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Protocol summary
Our purpose is to evaluate the effect of acupuncture on insomnia in pregnant women by the measuring urine melatonin before and after acupuncture and also use of sleep questionnaire, so that we can introduce a new simple and effective method for treatment of insomnia in pregnancy
To evaluate the effect of acupuncture on insomnia in pregnant women by the measuring urine melatonin before and after acupuncture, so that we can introduce effective method for treatment of insomnia in pregnancy
Our purpose is toTo evaluate the effect of acupuncture on insomnia in pregnant women by the measuring urine melatonin before and after acupuncture and also use of sleep questionnaire, so that we can introduce a new simple and effective method for treatment of insomnia in pregnancy
هدف ما از این مطالعه بررسی میزان اثربخشی آکوپانکچر از طریق اندازه گیری و مقایسه میزان ملاتونین ادرار قبل و بعد از انجام طب سوزنی ومعرفی روشی کارامد و کم خطر برای درمان بیخوابی در زنان باردار میباشد.
بررسی میزان اثربخشی آکوپانکچر از طریق اندازه گیری و مقایسه میزان ملاتونین ادرار قبل و بعد از انجام طب سوزنی ومعرفی روشی کارامد و کم خطر برای درمان بیخوابی در زنان باردار میباشد.
هدف ما از این مطالعه بررسی میزان اثربخشی آکوپانکچر از طریق اندازه گیری و مقایسه میزان ملاتونین ادرار قبل و بعد از انجام طب سوزنی ومعرفی روشی کارامد و کم خطر برای درمان بیخوابی در زنان باردار میباشد.
Both groups will also request to fill in a questionnaire. Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm. The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions. At the end of treatment again patients is ask to collect a night urine sample and also refuel sleep questionnaire and efficacy Acupuncture and sleep hygiene will be evaluated.
Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm. The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions. At the end of treatment again patients is ask to collect a night urine sample and also refuel sleep questionnaire and efficacy Acupuncture and sleep hygiene will be evaluated.
Both groups will also request to fill in a questionnaire. Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm. The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions. At the end of treatment again patients is ask to collect a night urine sample and also refuel sleep questionnaire and efficacy Acupuncture and sleep hygiene will be evaluated.
جهت بیماران دو گروه باید پرسشنامه های مربوطه تکمیل شود. پیش از شروع درمان طب سوزنی یا بهداشت خواب نمونه ادرار بین ساعات 11-12 شب از بیماران جمع آوری شده. درمان طب سوزنی توسط متخصص مربوطه بر روی نقاط از پیش تعیین شده و ترجیحا یک روز در میان تا 10 جلسه انجام میشود. پس از انتهای درمان مجدد نمونه ادرار شبانه جمع آوری شده،مقدار ملاتونین ادرار توسط کیتهای مخصوص سنجیده میشود.در انتها مقدار ملاتونین ادرار قبل و بعد از درمان طب سوزنی و بهداشت خواب باهم مقایسه و اثربخشی این روش درمانی سنجیده میشود.
پیش از شروع درمان طب سوزنی یا بهداشت خواب نمونه ادرار بین ساعات 11-12 شب از بیماران جمع آوری شده. درمان طب سوزنی توسط متخصص مربوطه بر روی نقاط از پیش تعیین شده و ترجیحا یک روز در میان تا 10 جلسه انجام میشود. پس از انتهای درمان مجدد نمونه ادرار شبانه جمع آوری شده،مقدار ملاتونین ادرار توسط کیتهای مخصوص سنجیده میشود.در انتها مقدار ملاتونین ادرار قبل و بعد از درمان طب سوزنی و بهداشت خواب باهم مقایسه و اثربخشی این روش درمانی سنجیده میشود.
جهت بیماران دو گروه باید پرسشنامه های مربوطه تکمیل شود. پیش از شروع درمان طب سوزنی یا بهداشت خواب نمونه ادرار بین ساعات 11-12 شب از بیماران جمع آوری شده. درمان طب سوزنی توسط متخصص مربوطه بر روی نقاط از پیش تعیین شده و ترجیحا یک روز در میان تا 10 جلسه انجام میشود. پس از انتهای درمان مجدد نمونه ادرار شبانه جمع آوری شده،مقدار ملاتونین ادرار توسط کیتهای مخصوص سنجیده میشود.در انتها مقدار ملاتونین ادرار قبل و بعد از درمان طب سوزنی و بهداشت خواب باهم مقایسه و اثربخشی این روش درمانی سنجیده میشود.
Inclusion criteria:
Women with aged between 20-45 years.
Gestational aged between 12 and 36 weeks
Women with Pittsburgh sleep quality index score more than 5.
Exclusion criteria:
Patients must not have suffered from insomnia before pregnancy.
-Patients must not have been treated by acupuncture within the preceding year.
Patients must not have high risk pregnancy (multifetal pregnancy, threated abortion, preeclampsia, …)
-Patient must not have been taking hypnotic drugs.
Inclusion criteria:
Age between 20-45 years.
Gestational aged between 12 and 36 weeks
Women with Pittsburgh sleep quality index score more than 5.
Exclusion criteria:
Patients must not have suffered from insomnia before pregnancy.
Patients must not have been treated by acupuncture within the preceding year.
Patients must not have high risk pregnancy
Patient must not have been taking hypnotic drugs.
Inclusion criteria: Women with agedAge between 20-45 years. Gestational aged between 12 and 36 weeks Women with Pittsburgh sleep quality index score more than 5. Exclusion criteria: Patients must not have suffered from insomnia before pregnancy. -Patients must not have been treated by acupuncture within the preceding year. Patients must not have high risk pregnancy (multifetal pregnancy, threated abortion, preeclampsia, …) -Patient must not have been taking hypnotic drugs.
شرایط ورود: سن بین 20-45
زنان باردار 12-36 هفته
زنان مبتلا به بیخوابی با امتیاز شاخص خواب پیترزبرگ بیشتر از 5
شرایط خروج از مطالعه:
زنان مبتلا به بیخوابی از قبل از بارداری
زنانی بارداری که از داروهای خواب اور استفاده میکنند
بیماران مبتلا به حاملگی پر خطر(بارداری چند قلویی،تهدید به سقط،مسمومیت بارداری،.......)
استفاده از طب سوزنی طی یکسال گذشته
شرایط ورود به مطالعه:
سن بین 20-45سال
زنان باردار 12-36 هفته
زنان مبتلا به بیخوابی با امتیاز شاخص خواب پیترزبرگ بیشتر از 5
شرایط خروج از مطالعه:
زنان مبتلا به بیخوابی از قبل از بارداری
زنانی بارداری که از داروهای خواب اور استفاده میکنند
بیماران مبتلا به حاملگی پر خطر
استفاده از طب سوزنی طی یکسال گذشته
شرایط ورود به مطالعه: سن بین 20-4545سال زنان باردار 12-36 هفته زنان مبتلا به بیخوابی با امتیاز شاخص خواب پیترزبرگ بیشتر از 5 شرایط خروج از مطالعه: زنان مبتلا به بیخوابی از قبل از بارداری زنانی بارداری که از داروهای خواب اور استفاده میکنند بیماران مبتلا به حاملگی پر خطر(بارداری چند قلویی،تهدید به سقط،مسمومیت بارداری،.......)خطر استفاده از طب سوزنی طی یکسال گذشته
72 subjects with sleep disorder will be assigned into 2 groups with Block randomization method, 36 patients will be treated by Acupuncture and sleep hygiene and 36 patients will be received only hygiene.
Both groups will also request to fill in a questionnaire. Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm.
The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions.
72 subjects with sleep disorder will be assigned into 2 groups with Block randomization method, 36 patients will be treated by Acupuncture and sleep hygiene and 36 patients will be received only hygiene.
Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm.
The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions.
72 subjects with sleep disorder will be assigned into 2 groups with Block randomization method, 36 patients will be treated by Acupuncture and sleep hygiene and 36 patients will be received only hygiene. Both groups will also request to fill in a questionnaire. Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm. The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions.
72 بیمار مبتلا به بیخوابی به طور تصادفی در دو گروه تقسیم بندی می شوند.36 نفر از آن ها تحت درمان با آکوپانکچر به علاوه بهداشت خواب قرار گرفته و 36 نفر تنها آموزش بهداشت داده می شوند.
جهت بیماران دو گروه باید پرسشنامه های مربوطه تکمیل شود.
پیش از شروع درمان طب سوزنی یا بهداشت خواب نمونه ادرار بین ساعات 11-12 شب از بیماران جمع آوری شده. درمان طب سوزنی توسط متخصص مربوطه بر روی نقاط از پیش تعیین شده و ترجیحا یک روز در میان تا 10 جلسه انجام میشود.
72 بیمار مبتلا به بیخوابی به طور تصادفی در دو گروه تقسیم بندی می شوند. 36 نفر از آن ها تحت درمان با آکوپانکچر به علاوه بهداشت خواب قرار گرفته و 36 نفر تنها آموزش بهداشت داده می شوند.
پیش از شروع درمان طب سوزنی یا بهداشت خواب نمونه ادرار بین ساعات 11-12 شب از بیماران جمع آوری شده. درمان طب سوزنی توسط متخصص مربوطه بر روی نقاط از پیش تعیین شده و ترجیحا یک روز در میان تا 10 جلسه انجام میشود.
72 بیمار مبتلا به بیخوابی به طور تصادفی در دو گروه تقسیم بندی می شوند.36شوند. 36 نفر از آن ها تحت درمان با آکوپانکچر به علاوه بهداشت خواب قرار گرفته و 36 نفر تنها آموزش بهداشت داده می شوند. جهت بیماران دو گروه باید پرسشنامه های مربوطه تکمیل شود. پیش از شروع درمان طب سوزنی یا بهداشت خواب نمونه ادرار بین ساعات 11-12 شب از بیماران جمع آوری شده. درمان طب سوزنی توسط متخصص مربوطه بر روی نقاط از پیش تعیین شده و ترجیحا یک روز در میان تا 10 جلسه انجام میشود.
At the end of treatment again patients is ask to collect a night urine sample and also refuel sleep questionnaire and efficacy Acupuncture and sleep hygiene will be evaluated.
Finally, urinary melatonin levels are compared before and after acupuncture treatment and sleep hygiene and the effectiveness of this treatment is evaluated.
At the end of treatment again patients is ask to collect a night urine sampleFinally, urinary melatonin levels are compared before and also refuel sleep questionnaire and efficacy Acupunctureafter acupuncture treatment and sleep hygiene will beand the effectiveness of this treatment is evaluated.
پس از انتهای درمان مجدد نمونه ادرار شبانه جمع آوری شده،مقدار ملاتونین ادرار توسط کیتهای مخصوص سنجیده میشود.در انتها مقدار ملاتونین ادرار قبل و بعد از درمان طب سوزنی و بهداشت خواب باهم مقایسه و اثربخشی این روش درمانی سنجیده میشود.
در انتها مقدار ملاتونین ادرار قبل و بعد از درمان طب سوزنی و بهداشت خواب باهم مقایسه و اثربخشی این روش درمانی سنجیده میشود.
پس از انتهای درمان مجدد نمونه ادرار شبانه جمع آوری شده،مقدار ملاتونین ادرار توسط کیتهای مخصوص سنجیده میشود.دردر انتها مقدار ملاتونین ادرار قبل و بعد از درمان طب سوزنی و بهداشت خواب باهم مقایسه و اثربخشی این روش درمانی سنجیده میشود.
General information
2017-11-11, 1396/08/20
2017-12-21, 1396/09/30
2017-1112-1121 00:00:00
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empty
empty
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Recruitment centers
#1
Name of recruitment center - English: Hafez Clinic of Shiraz University of Medical Sciences
Name of recruitment center - Persian: درمانگاه حافظ دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Saeedeh Froghinia
Full name of responsible person - Persian: سعیده فروغی نیا
Street address - English: Shahid Chamran blvd, Hafez Clinic
Street address - Persian: بلوار شهید چمران، درمانگاه حافظ
City - English: Shiraz
City - Persian: شیراز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Hafez Clinic of Shiraz University of Medical Sciences
Name of recruitment center - Persian: درمانگاه حافظ دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Saeedeh Froghinia
Full name of responsible person - Persian: سعیده فروغی نیا
Street address - English: Shahid Chamran blvd, Hafez Clinic
Street address - Persian: بلوار شهید چمران، درمانگاه حافظ
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 34786-71946
Phone: +98 71 3612 8257
Fax:
Email: sd.foroughinia@yahoo.com
Web page address:
Name of recruitment center - English: Hafez Clinic of Shiraz University of Medical Sciences Name of recruitment center - Persian: درمانگاه حافظ دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Saeedeh Froghinia Full name of responsible person - Persian: سعیده فروغی نیا Street address - English: Shahid Chamran blvd, Hafez Clinic Street address - Persian: بلوار شهید چمران، درمانگاه حافظ City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 34786-71946 Phone: +98 71 3612 8257 Fax: Email: sd.foroughinia@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Shiraz University Of medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr Seyed Baser Hashemi
Full name of responsible person - Persian: دکتر سید بصیر هاشمی
Street address - English: Building of Shiraz University of Medical Sciences, Zand Ave
Street address - Persian: خیابان زند، ساختمان دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Shiraz University Of medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr Seyed Baser Hashemi
Full name of responsible person - Persian: دکتر سید بصیر هاشمی
Street address - English: Building of Shiraz University of Medical Sciences, Zand Ave
Street address - Persian: خیابان زند، ساختمان دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 34786-71946
Phone: +98 71 3230 5410
Fax:
Email: hashemib@sums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shiraz University Of medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Dr Seyed Baser Hashemi Full name of responsible person - Persian: دکتر سید بصیر هاشمی Street address - English: Building of Shiraz University of Medical Sciences, Zand Ave Street address - Persian: خیابان زند، ساختمان دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 34786-71946 Phone: +98 71 3230 5410 Fax: Email: hashemib@sums.ac.ir Web page address:
Protocol summary
Study aim
To evaluate the effect of acupuncture on insomnia in pregnant women by the measuring urine melatonin before and after acupuncture, so that we can introduce effective method for treatment of insomnia in pregnancy
Design
72 subjects with sleep disorder will be assigned into 2 groups with Block randomization method, 36 patients will be treated by Acupuncture and sleep hygiene and 36 patients will be received only hygiene.
Settings and conduct
Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm. The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions. At the end of treatment again patients is ask to collect a night urine sample and also refuel sleep questionnaire and efficacy Acupuncture and sleep hygiene will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 20-45 years.
Gestational aged between 12 and 36 weeks
Women with Pittsburgh sleep quality index score more than 5.
Exclusion criteria:
Patients must not have suffered from insomnia before pregnancy.
Patients must not have been treated by acupuncture within the preceding year.
Patients must not have high risk pregnancy
Patient must not have been taking hypnotic drugs.
Intervention groups
72 subjects with sleep disorder will be assigned into 2 groups with Block randomization method, 36 patients will be treated by Acupuncture and sleep hygiene and 36 patients will be received only hygiene.
Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm.
The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions.
Main outcome variables
Finally, urinary melatonin levels are compared before and after acupuncture treatment and sleep hygiene and the effectiveness of this treatment is evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140525017827N3
Registration date:2017-12-10, 1396/09/19
Registration timing:prospective
Last update:2019-09-15, 1398/06/24
Update count:1
Registration date
2017-12-10, 1396/09/19
Registrant information
Name
Nasrin Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
asadin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University Of medical Science
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of KI-3. HT-7. ST-36. PC-6, anmian I, GB-20, DU-20 acupuncture on relieving insomnia in pregnant woman
Public title
The effect of acupuncture on insomnia in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Women with aged between 20-45 years. Gestational aged between 12 and 36 weeks Women with Pittsburgh sleep quality index score more than 5. Exclusion criteria: Patients must not have suffered from insomnia before pregnancy. Patients must not have been treated by acupuncture within the preceding year. Patients must not have high risk pregnancy (multifetal pregnancy, threated abortion, preeclampsia, …) Patient must not have been taking hypnotic drugs
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2017-07-20, 1396/04/29
Ethics committee reference number
IR.SUMS.MED.REC.1396.77
Health conditions studied
1
Description of health condition studied
Nonorganic insomnia
ICD-10 code
F51.0
ICD-10 code description
maternal disorders predominantly related to pregnancy
Primary outcomes
1
Description
Measurment of urine Melatonine
Timepoint
before and after treatment
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
10 sessions of 20 minutes acupuncture
Category
Treatment - Drugs
2
Description
Observe 14 health issues
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Saeedeh Froghinia
Street address
Shahid Chamran blvd, Hafez Clinic
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
sd.foroughinia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of medical Science
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3230 5410
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University Of medical Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Saaedeh Froghinia
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Fax
Email
sd.foroughinia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin asadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Fax
Email
nasadi2012@yahoo.ca
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin asadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Fax
Email
nasadi2012@yahoo.ca
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
IPD: Information and research data
Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2018
Ethic form: 2018
To whom data/document is available
IPD: Researcher & Patient
Ethic form: Patient
Under which criteria data/document could be used
IPD:
Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences
Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document