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Protocol summary
The main objective of this study is the impact of pelvic floor physical therapy on sexual function and pelvic floor muscle strength and endurance in women complaining dyspareunia.Among patients in the female urology clinic located at Talegani, Azzahra, Emam reza hospital, women with dyspareunia selected. After explaining the different treatments, volunteers participating in this project will be treated with physical therapy. The minimum sample size is 25.Initially all patients will be seen by a trained psychologist. Neuropsychiatric disease has proven to be excluded. Then all the subjects under examination will be objective and subjective evaluated. Subjective evaluation includes determination of pain and completing the female sexual function index (FSFI) questionnaire. Objective evaluation that will be conducted by physiotherapist and gynecologist, include vaginal exam and determining the severity of tenderness, muscle strength (based on a scoring system of oxford) and pelvic floor muscle endurance (time to maintain muscle contraction).Examples include individuals who have been dyspaunia and they are under pelvic floor rehabilitation treatments by a physiotherapist for 10 sessions during 3 months. After evaluating patients and determining the location of active trigger points, my facial release technical will be performed for patients and pelvic floor muscle training based on the initial strength of the patient will be prescribed.Finally, patients evaluated by a gynecologist to vary the intensity of dyspareunia,symptoms improvement and pelvic floor muscles strength and endurance before and after intervention will be compared.
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The main objective of this study is the impact of pelvic floor physical therapy on sexual function and pelvic floor muscle strength and endurance in women complaining dyspareunia.Among patients in the female urology clinic located at Talegani, Azzahra, Emam reza hospital, women with dyspareunia selected. After explaining the different treatments, volunteers participating in this project will be treated with physical therapy. The minimum sample size is 25.Initially all patients will be seen by a trained psychologist. Neuropsychiatric disease has proven to be excluded. Then all the subjects under examination will be objective and subjective evaluated. Subjective evaluation includes determination of pain and completing the female sexual function index (FSFI) questionnaire. Objective evaluation that will be conducted by physiotherapist and gynecologist, include vaginal exam and determining the severity of tenderness, muscle strength (based on a scoring system of oxford) and pelvic floor muscle endurance (time to maintain muscle contraction).Examples include individuals who have been dyspaunia and they are under pelvic floor rehabilitation treatments by a physiotherapist for 10 sessions during 3 months. After evaluating patients and determining the location of active trigger points, my facial release technical will be performed for patients and pelvic floor muscle training based on the initial strength of the patient will be prescribed.Finally, patients evaluated by a gynecologist to vary the intensity of dyspareunia,symptoms improvement and pelvic floor muscles strength and endurance before and after intervention will be compared.
هدف اصلی در این مطالعه تاثیر درمانهای فیزیکی کف لگن بر عملکرد جنسی وقدرت وتحمل عضلات کف لگن در زنان مبتلا به آمیزش دردناک می باشد.
این مطالعه کار آزمایی بالینی بدون گروه شاهد است.
معیار اصلی ورود به مطالعه:زنان فعال از نظر جنسی با شکایت دیسپارونی است.
زنان حامله وشیر ده وزنان با سابقه جراحی ولو و واژن و زنان با بیماری عصبی و روحی وپرولاپس ارگانهای لگنی و اندومتریوز ومیوم رحمی از مطالعه حذف میشوند.
حجم نمونه حداقل 25 نفر است.زنان مبتلا به آمیزش دردناک مراجعه کننده به بیمارستان الزهرا و علاقه مند به شرکت در مطالعه توسط روانشناس ویزیت خواهند شد تا مبتلایان بیماری عصبی روانی از مطالعه حذف شوند.سپس افراد مورد مطالعه تحت ارزیابی های ذهنی (تکمیل پرسشنامه FSFI وعینی (معاینه واژینال وتعیین شدت تندرنس و قدرت عضلانی بر اساس معیار اکسفورد وتحمل عضلانی :مدت زمان حفظ انقباض ) قرار می گیرند.سپس به مدت ده جلسه طی سه ماه تحت در مانهای فیزیکی کف لگن قرار گرفته ,بعد اتمام جلسات توسط یک متخصص زنان از نظر تغییر شدت دیسپارونی, بهبودی علایم و قدرت و تحمل عضلات کف لگن قبل و بعد از مداخله مقایسه خواهند شد.
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هدف اصلی در این مطالعه تاثیر درمانهای فیزیکی کف لگن بر عملکرد جنسی وقدرت وتحمل عضلات کف لگن در زنان مبتلا به آمیزش دردناک می باشد. این مطالعه کار آزمایی بالینی بدون گروه شاهد است. معیار اصلی ورود به مطالعه:زنان فعال از نظر جنسی با شکایت دیسپارونی است. زنان حامله وشیر ده وزنان با سابقه جراحی ولو و واژن و زنان با بیماری عصبی و روحی وپرولاپس ارگانهای لگنی و اندومتریوز ومیوم رحمی از مطالعه حذف میشوند. حجم نمونه حداقل 25 نفر است.زنان مبتلا به آمیزش دردناک مراجعه کننده به بیمارستان الزهرا و علاقه مند به شرکت در مطالعه توسط روانشناس ویزیت خواهند شد تا مبتلایان بیماری عصبی روانی از مطالعه حذف شوند.سپس افراد مورد مطالعه تحت ارزیابی های ذهنی (تکمیل پرسشنامه FSFI وعینی (معاینه واژینال وتعیین شدت تندرنس و قدرت عضلانی بر اساس معیار اکسفورد وتحمل عضلانی :مدت زمان حفظ انقباض ) قرار می گیرند.سپس به مدت ده جلسه طی سه ماه تحت در مانهای فیزیکی کف لگن قرار گرفته ,بعد اتمام جلسات توسط یک متخصص زنان از نظر تغییر شدت دیسپارونی, بهبودی علایم و قدرت و تحمل عضلات کف لگن قبل و بعد از مداخله مقایسه خواهند شد.
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The effects of Pelvic floor rehabilitation in treatment of women with dyspareunia
The effects of Pelvic floor rehabilitation in treatment of women with dyspareunia
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بررسی تاثیر فیزیوتراپی کف لگن در درمان زنان مبتلا به دیس پارونیا
بررسی تاثیر فیزیوتراپی کف لگن در درمان زنان مبتلا به دیس پارونیا
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Two arm parallel group randomized controlled trial with blinded outcome assessment, sample size 64
Two arm parallel group randomized controlled trial with blinded outcome assessment, sample size 64
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کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ( ارزیابی کننده) ، تصادفی شده، حجم نمونه 64
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ( ارزیابی کننده) ، تصادفی شده، حجم نمونه 64
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Dyspareunia patients from Alzahra hospital and physiotherapy center who met the criteria were included in the study.
Treatment was done by one of the researchers and assessment was done by another one who was blinded to group allocation.
Dyspareunia patients from Alzahra hospital and physiotherapy center who met the criteria were included in the study. Treatment was done by one of the researchers and assessment was done by another one who was blinded to group allocation.
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بیماران مبتلا به دیسپارونیا در بیمارستان الزهرا و بخش فیزیوتراپی که معیار های ورود به مطالعه را داشتند وارد مطالعه شدند . درمان توسط یک محقق و ارزیابی توسط محقق دیگری که نسبت به گروهها غیر مطلع بود صورت گرفت.
بیماران مبتلا به دیسپارونیا در بیمارستان الزهرا و بخش فیزیوتراپی که معیار های ورود به مطالعه را داشتند وارد مطالعه شدند . درمان توسط یک محقق و ارزیابی توسط محقق دیگری که نسبت به گروهها غیر مطلع بود صورت گرفت.
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Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS).
If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS). If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
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زنان با شکایت ابتلا به درد در ناحیه تناسلی قبل ,حین یا بعد از نزدیکی که شدت درد آنها در مقیاس بینایی درد بالاتر از 8 بود وارد مطالعه می شدند .
زنان با سابقه ابتلا به عفونت , تومور بیماریهای روانی, واژینسموس , وستیبولودینیا , بیماریهای درماتولوژیکی والو واژن , سندوم مثانه دردناک , کیست اینتر استیشیال, اندمتریوز, حاملگی ,جراحی در ارگانهای لگن یا درمان های قبلی برای دیسپارونیا از مطالعه خارج میشدند
زنان با شکایت ابتلا به درد در ناحیه تناسلی قبل ,حین یا بعد از نزدیکی که شدت درد آنها در مقیاس بینایی درد بالاتر از 8 بود وارد مطالعه می شدند . زنان با سابقه ابتلا به عفونت , تومور بیماریهای روانی, واژینسموس , وستیبولودینیا , بیماریهای درماتولوژیکی والو واژن , سندوم مثانه دردناک , کیست اینتر استیشیال, اندمتریوز, حاملگی ,جراحی در ارگانهای لگن یا درمان های قبلی برای دیسپارونیا از مطالعه خارج میشدند
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Intervention Group: Pelvic floor physiotherapy (n=32)
Control group: No treatment(n=32)
Intervention Group: Pelvic floor physiotherapy (n=32) Control group: No treatment(n=32)
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گروه مداخله: فیزیوتراپی کف لگن
گروه کنترل : بدون درمان
گروه مداخله: فیزیوتراپی کف لگن گروه کنترل : بدون درمان
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pain;
pelvic floor muscles and deep abdominals strength and endurance;
female sexual functional index (FSFI).
pain; pelvic floor muscles and deep abdominals strength and endurance; female sexual functional index (FSFI).
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درد
قدرت و تحمل عضلات کف لگن و عمقی شکم
معیار عملکرد جنسی زنان
درد قدرت و تحمل عضلات کف لگن و عمقی شکم معیار عملکرد جنسی زنان
General information
N/A
Randomized
narand
Not blinded
Single blinded
notblsingl
1
1
1
1
Single
Parallel
singlparal
25
64
2564
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64
64
2014-09-11, 1393/06/20
2016-09-20, 1395/06/30
20142016-09-1120 00:00:00
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2014-09-21, 1393/06/30
2014-09-21 00:00:00
empty
2016-09-20, 1395/06/30
2016-09-20 00:00:00
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2016-09-20, 1395/06/30
2016-09-20 00:00:00
Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS).
Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS).
زنان مبتلا به درد ناحیه تناسلی قبل حین یا بعد از نزدیکی که در مقیاس دیداری درد میزان درد خود را بیشتر از 8 گزارش کنند
زنان مبتلا به درد ناحیه تناسلی قبل حین یا بعد از نزدیکی که در مقیاس دیداری درد میزان درد خود را بیشتر از 8 گزارش کنند
If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
در صورتیکه بیمار مبتلا به پاتولوژیهایی از قبیل عفونت , بیماریهای شدید روانی , تومور, واژینیسموس, وستیبولو دینیا , مشکلات درماتولوژیک والو واژن , کیست بینابینی , سندوم مثانه دردناک , اندمتریوز, حاملگی , جراحی روی ارگانهای لگن یا هر درمان قبلی در مورد دیسپارونیا از مطالعه خارج خواهد شد.
در صورتیکه بیمار مبتلا به پاتولوژیهایی از قبیل عفونت , بیماریهای شدید روانی , تومور, واژینیسموس, وستیبولو دینیا , مشکلات درماتولوژیک والو واژن , کیست بینابینی , سندوم مثانه دردناک , اندمتریوز, حاملگی , جراحی روی ارگانهای لگن یا هر درمان قبلی در مورد دیسپارونیا از مطالعه خارج خواهد شد.
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participants were randomly assigned to one of two groups using
a block randomization procedure . The allocation sequence was generated by random allocation software.
participants were randomly assigned to one of two groups using a block randomization procedure . The allocation sequence was generated by random allocation software.
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با استفاده از روش تخصیص بلوکهای تصادفی شرکت کنندگان در دو گروه مطالعه و کنترل قرار گرفتند . تصادفی سازی با استفاده از نرم افزار RAS انجام شد.
با استفاده از روش تخصیص بلوکهای تصادفی شرکت کنندگان در دو گروه مطالعه و کنترل قرار گرفتند . تصادفی سازی با استفاده از نرم افزار RAS انجام شد.
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Blinding only occurred for assessor and statistician. Because of the nature of the intervention and control, participants and physiotherapist couldn’t be blinded.
blinded assessor did the assessment procedure including questionnaires and examination.
Blinding only occurred for assessor and statistician. Because of the nature of the intervention and control, participants and physiotherapist couldn’t be blinded. blinded assessor did the assessment procedure including questionnaires and examination.
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بدلیل ماهیت مداخله و کنترل در دو گروه بیمار و درمانگر نمیتوانست نسبت به گروهها کور شده باشد ولی کور سازی فقط در مورد ارزیابی کننده و آمارگر صورت گرفت .تکمیل پرسشنامه و معاینه قبل و بعد از درمان توسط همکار محقق که نسبت به گروهها غیر مطلع بود صورت گرفت .
بدلیل ماهیت مداخله و کنترل در دو گروه بیمار و درمانگر نمیتوانست نسبت به گروهها کور شده باشد ولی کور سازی فقط در مورد ارزیابی کننده و آمارگر صورت گرفت .تکمیل پرسشنامه و معاینه قبل و بعد از درمان توسط همکار محقق که نسبت به گروهها غیر مطلع بود صورت گرفت .
minimum25
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minimum25
25
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25
Primary outcomes
#1
Before and after Physiotherapy
Before and after intervention
Before and after Physiotherapyintervention
قبل و بعد از انجام فیزیوتراپی
قبل و بعد از انجام مداخله
قبل و بعد از انجام فیزیوتراپیمداخله
Questionnaire
VAS
QuestionnaireVAS
پرسشنامه
مقیاس بینایی درد
پرسشنامهمقیاس بینایی درد
#2
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Female sexual function index (FSFI)
Female sexual function index (FSFI)
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نمره عملکرد جنسی زنان
نمره عملکرد جنسی زنان
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before and after intervention
before and after intervention
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قبل و بعد از مداخله
قبل و بعد از مداخله
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
Secondary outcomes
#1
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PFM strength
PFM strength
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قدرت عضلات کف لگن
قدرت عضلات کف لگن
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before after intervention
before after intervention
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قبل و بعد از مداخله
قبل و بعد از مداخله
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oxford scale- vaginal examination
oxford scale- vaginal examination
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معاینه واژینال- معیار اکسفورد
معاینه واژینال- معیار اکسفورد
#2
empty
PFM endurance
PFM endurance
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تحمل عضلات کف لگن
تحمل عضلات کف لگن
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before after intervention
before after intervention
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قبل و بعد از مداخله
قبل و بعد از مداخله
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oxford scale- vaginal examination
oxford scale- vaginal examination
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معاینه واژینال- معیار اکسفورد
معاینه واژینال- معیار اکسفورد
Intervention groups
#1
Other
Rehabilitation
otherrehabilitaion
Patients will be 10 physiotherapy sessions for three months
Patients had 10 physiotherapy sessions for three months
Patients will behad 10 physiotherapy sessions for three months
#2
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N/A
na
empty
Control group: no treatment ( waiting list)
Control group: no treatment ( waiting list)
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گروه کنترل: بدون درمان ( لیست انتظار)
گروه کنترل: بدون درمان ( لیست انتظار)
Recruitment centers
#1
Name of recruitment center - English: Alzahra Hospital
Name of recruitment center - Persian: بیمارستان الزهرا(س)
Full name of responsible person - English: Dr.Parvin Bastani Alamdari
Full name of responsible person - Persian: دکتر پروین باستانی علمداری
Street address - English:
Street address - Persian:
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Fariba Ghaderi
Name of recruitment center - Persian: Fariba Ghaderi
Full name of responsible person - English: Fariba Ghaderi
Full name of responsible person - Persian: Fariba Ghaderi
Street address - English: Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
Street address - Persian: تبریز - توانیر شمالی - دانشکده توانبخشی
City - English: Tabriz
City - Persian: Tabriz
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5167631444
Phone: +98 41 3337 5359
Fax:
Email: ghaderimailbox@gmail.com
Web page address:
Name of recruitment center - English: Alzahra HospitalFariba Ghaderi Name of recruitment center - Persian: بیمارستان الزهرا(س)Fariba Ghaderi Full name of responsible person - English: Dr.Parvin Bastani AlamdariFariba Ghaderi Full name of responsible person - Persian: دکتر پروین باستانی علمداریFariba Ghaderi Street address - English: Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran Street address - Persian: تبریز - توانیر شمالی - دانشکده توانبخشی City - English: Tabriz City - Persian: تبریزTabriz Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5167631444 Phone: +98 41 3337 5359 Fax: Email: ghaderimailbox@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for Research,Tabriz University Of Medical Sciences
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr.Alireza Rashidi
Full name of responsible person - Persian: دکتر علیرضا رشیدی
Street address - English: Third Floor, Central Building of Number2, Golgasht Street
Street address - Persian: خیابان گلگشت- ساختمان مرکزی شماره دو-طبقه سوم
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Fariba Ghaderi
Full name of responsible person - Persian: Fariba Ghaderi
Street address - English: Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
Street address - Persian: خیابان گلگشت- ساختمان مرکزی شماره دو-طبقه سوم
City - English: Tabriz
City - Persian: Tabriz
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5167631444
Phone: +98 41 3337 5359
Fax:
Email: ghaderimailbox@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for Research,TabrizTabriz University Of Medical Sciences Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr.Alireza RashidiFariba Ghaderi Full name of responsible person - Persian: دکتر علیرضا رشیدیFariba Ghaderi Street address - English: Third Floor, Central BuildingFaculty of Number2rehabilitation, Golgasht StreetTavanir Ave, Tabriz, Iran Street address - Persian: خیابان گلگشت- ساختمان مرکزی شماره دو-طبقه سوم City - English: Tabriz City - Persian: تبریزTabriz Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5167631444 Phone: +98 41 3337 5359 Fax: Email: ghaderimailbox@gmail.com Web page address:
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice chancellor for Research,Tabriz University Of Medical Sciences
Tabriz University Of Medical Sciences
Vice chancellor for Research,TabrizTabriz University Of Medical Sciences
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز
دانشگاه علوم پزشکی تبریز
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: دانشگاه علوم پزشکی تبریز
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr Parvin Bastani Alamdari
Full name of responsible person - Persian: دکتر پروین باستانی علمداری
Position - English: Associate Professor of Obstetrics and Gynecology
Position - Persian: دانشیار زنان و مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golgasht Street ,Tabriz University Of Medical Sciences
Street address - Persian: خیابان گلگشت- دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 1556 9543
Mobile: +98 914 311 0142
Fax:
Email: wrhrcenter@gmail.com;lahrodi59@yahoo.com;bastanip@tbzmed.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fariba Ghaderi
Full name of responsible person - Persian: Fariba Ghaderi
Position - English: Associate Professor of Obstetrics and Gynecology
Position - Persian: دانشیار زنان و مامایی
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
Street address - Persian: خیابان گلگشت- دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: Tabriz
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5167631444
Phone: +98 41 3337 5359
Mobile: +98 914 311 0142
Fax:
Email: ghaderimailbox@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: دانشگاه علوم پزشکی تبریز Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr Parvin Bastani AlamdariFariba Ghaderi Full name of responsible person - Persian: دکتر پروین باستانی علمداریFariba Ghaderi Position - English: Associate Professor of Obstetrics and Gynecology Position - Persian: دانشیار زنان و مامایی Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Golgasht Street Faculty of rehabilitation, Tavanir Ave, Tabriz University Of Medical Sciences, Iran Street address - Persian: خیابان گلگشت- دانشگاه علوم پزشکی تبریز City - English: Tabriz City - Persian: تبریزTabriz Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 51386657935167631444 Phone: +98 41 1556 95433337 5359 Mobile: +98 914 311 0142 Fax: Email: wrhrcenterghaderimailbox@gmail.com;lahrodi59@yahoo.com;bastanip@tbzmed.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr Parvin Bastani Alamdari
Full name of responsible person - Persian: دکتر پروین باستانی علمداری
Position - English: Associate Professor of Obstetrics and Gynecology
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golgasht Street ,Tabriz University Of Medical Sciences
Street address - Persian: خیابان گلگشت دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 1556 9543
Mobile: +98 914 311 0142
Fax:
Email: wrhrcenter@gmail.com;lahrodi59@yahoo.com;bastanip@tbzmed.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Parvin Bastani Alamdari
Full name of responsible person - Persian: دکتر پروین باستانی علمداری
Position - English: Associate Professor of Obstetrics and Gynecology
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golgasht Street ,Tabriz University Of Medical Sciences
Street address - Persian: خیابان گلگشت دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 1556 9543
Mobile: +98 914 311 0142
Fax:
Email: ghaderimailbox@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr Parvin Bastani Alamdari Full name of responsible person - Persian: دکتر پروین باستانی علمداری Position - English: Associate Professor of Obstetrics and Gynecology Position - Persian: دانشیار Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Golgasht Street ,Tabriz University Of Medical Sciences Street address - Persian: خیابان گلگشت دانشگاه علوم پزشکی تبریز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5138665793 Phone: +98 41 1556 9543 Mobile: +98 914 311 0142 Fax: Email: wrhrcenterghaderimailbox@gmail.com;lahrodi59@yahoo.com;bastanip@tbzmed.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Women's Reproductive Health Research Center
Name of organization / entity - Persian: مرکز تحقیقفات سلامت باروری زنان
Full name of responsible person - English: Dr Parvin Bastani Alamdari
Full name of responsible person - Persian: دکتر پروین باستانی علمداری
Position - English: Associate Professor Obstetrics Midwifery
Position - Persian: دانشیار زنان و مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Women's Reproductive Health Research Center, Alzahra hospital,Artesh jonoobi avenue
Street address - Persian: مرکز تحقیقات سلامت باروری زنان - بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138665793
Phone: +98 41 1553 9161
Mobile: 00
Fax:
Email: wrhrcenter@gmail.com;lahrodi59@yahoo.com;bastanip@tbzmed.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fariba Ghaderi
Full name of responsible person - Persian: Fariba Ghaderi
Position - English: Associate Professor
Position - Persian: دانشیار زنان و مامایی
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
Street address - Persian: مرکز تحقیقات سلامت باروری زنان - بیمارستان الزهرا
City - English: Tabriz
City - Persian: Tabriz
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5167631444
Phone: +98 41 3337 5359
Mobile: +98 914 311 0142
Fax:
Email: ghaderimailbox@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Women's Reproductive Health Research Center Name of organization / entity - Persian: مرکز تحقیقفات سلامت باروری زنان Full name of responsible person - English: Dr Parvin Bastani AlamdariFariba Ghaderi Full name of responsible person - Persian: دکتر پروین باستانی علمداریFariba Ghaderi Position - English: Associate Professor Obstetrics Midwifery Position - Persian: دانشیار زنان و مامایی Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Women's Reproductive Health Research CenterFaculty of rehabilitation, Alzahra hospital,Artesh jonoobi avenueTavanir Ave, Tabriz, Iran Street address - Persian: مرکز تحقیقات سلامت باروری زنان - بیمارستان الزهرا City - English: Tabriz City - Persian: تبریزTabriz Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 51386657935167631444 Phone: +98 41 1553 91613337 5359 Mobile: 00+98 914 311 0142 Fax: Email: wrhrcenterghaderimailbox@gmail.com;lahrodi59@yahoo.com;bastanip@tbzmed.ac.ir Web page address:
Sharing plan
no
no
yes
yes
yes
yes
no
no
yes
yes
undecided
undecided
undecided
undecided
empty
There is no further information
There is no further information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
empty
study protocol- data set
study protocol- data set
empty
پروتوکل مطالعه - جدول داده ها
پروتوکل مطالعه - جدول داده ها
empty
starting 6 months after publication
starting 6 months after publication
empty
6 ماه پس از چاپ نتایج
6 ماه پس از چاپ نتایج
empty
only available for people working in academic institutions
only available for people working in academic institutions
empty
محققین شاغل در موسسات دانشگاهی و علمی
محققین شاغل در موسسات دانشگاهی و علمی
empty
data analysis with referencing this study
data analysis with referencing this study
empty
آنالیز داده ها با ذکر مطالعه حاضر
آنالیز داده ها با ذکر مطالعه حاضر
empty
researcher email
ghaderimailbox@gmail.com
researcher email ghaderimailbox@gmail.com
empty
ایمیل محقق
ghaderimailbox@gmail.com
ایمیل محقق ghaderimailbox@gmail.com
empty
sending an email
sending an email
empty
ارسال ایمیل و نوع درخواست
ارسال ایمیل و نوع درخواست
Protocol summary
Study aim
The effects of Pelvic floor rehabilitation in treatment of women with dyspareunia
Design
Two arm parallel group randomized controlled trial with blinded outcome assessment, sample size 64
Settings and conduct
Dyspareunia patients from Alzahra hospital and physiotherapy center who met the criteria were included in the study.
Treatment was done by one of the researchers and assessment was done by another one who was blinded to group allocation.
Participants/Inclusion and exclusion criteria
Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS).
If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
Intervention groups
Intervention Group: Pelvic floor physiotherapy (n=32)
Control group: No treatment(n=32)
Main outcome variables
pain;
pelvic floor muscles and deep abdominals strength and endurance;
female sexual functional index (FSFI).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2014070118311N1
Registration date:2014-08-09, 1393/05/18
Registration timing:prospective
Last update:2019-04-25, 1398/02/05
Update count:1
Registration date
2014-08-09, 1393/05/18
Registrant information
Name
Parvin Bastani
Name of organization / entity
Tabriz University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1443 5590
Email address
bastanip@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2014-07-11, 1393/04/20
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
2014-09-21, 1393/06/30
Actual recruitment end date
2016-09-20, 1395/06/30
Trial completion date
2016-09-20, 1395/06/30
Scientific title
The effect of pelvic floor physical therapy on sexual function and pelvic floor muscle strength and endurance in women complaining dyspareunia
Public title
The effect of pelvic floor physical therapy on dyspareunia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS).
Exclusion criteria:
If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
participants were randomly assigned to one of two groups using
a block randomization procedure . The allocation sequence was generated by random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding only occurred for assessor and statistician. Because of the nature of the intervention and control, participants and physiotherapist couldn’t be blinded.
blinded assessor did the assessment procedure including questionnaires and examination.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Approval date
2014-06-26, 1393/04/05
Ethics committee reference number
5/4/2979
Health conditions studied
1
Description of health condition studied
Dyspareunia
ICD-10 code
N94.1
ICD-10 code description
Dyspareunia
Primary outcomes
1
Description
dyspareunia
Timepoint
Before and after intervention
Method of measurement
VAS
2
Description
Female sexual function index (FSFI)
Timepoint
before and after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
PFM strength
Timepoint
before after intervention
Method of measurement
oxford scale- vaginal examination
2
Description
PFM endurance
Timepoint
before after intervention
Method of measurement
oxford scale- vaginal examination
Intervention groups
1
Description
Patients had 10 physiotherapy sessions for three months
Category
Rehabilitation
2
Description
Control group: no treatment ( waiting list)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fariba Ghaderi
Full name of responsible person
Fariba Ghaderi
Street address
Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Email
ghaderimailbox@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Email
ghaderimailbox@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Associate Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Fax
Email
ghaderimailbox@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parvin Bastani Alamdari
Position
Associate Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1556 9543
Fax
Email
ghaderimailbox@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Faculty of rehabilitation, Tavanir Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Fax
Email
ghaderimailbox@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
study protocol- data set
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
data analysis with referencing this study
From where data/document is obtainable
researcher email
ghaderimailbox@gmail.com
What processes are involved for a request to access data/document