History
# Registration date Revision Id
2 2019-05-20, 1398/02/30 93031
1 2014-05-27, 1393/03/06 15025
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  • Protocol summary

    The aim of this study was to determine the effects of guided imagery on anxiety of patients before abdominal surgery. Some of inclusion criteria included: patients 15 to 49 years old; abdominal surgery (appendicitis and hernia requiring surgical intervention); having full consciousness. In this randomized clinical trial, 116 patients undergoing appendectomy and herniorrhaphy in Sabzevar Beheshti Hospital in 2014 will be randomly assign to intervention and control groups. After the initial selection of samples, demographic data form and STAI anxiety questionnaire is completed by both groups. For the intervention group, 18-minute guided visualization CD will be played through headphones, which include visualization of the beautiful scenery and pleasant (the beach) and positively associated with increased wellness is empathy. The control group received routine care.
    empty
    هدف از انجام این مطالعه تعیین تأثیر تجسم هدایت شده بر میزان اضطراب بیماران قبل از اعمال جراحی شکم می باشد. برخی از معیارهای ورود عبارتند از: بیماران 15 تا 49 ساله؛ اعمال جراحی شکم (آپاندیسیت و هرنی نيازمند به مداخله جراحي)؛ داشتن هوشیاری کامل. در این کارآزمایی بالینی تصادفی شده، 116بیمار کاندید عمل جراحی آپاندکتومی و هرنیورافی، بستری در بیمارستان شهید بهشتی سبزوار در سال 1392 به صورت تصادفی به دو گروه مداخله و کنترل تقسیم خواهند شد. پس از انتخاب اولیه نمونه ها، فرم اطلاعات فردی بیماری و پرسشنامه اضطراب اشپیل برگر در هر دو گروه تکمیل می شود. برای افراد گروه مداخله، 18 دقیقه از طریق هدفون سی دی تجسم هدایت شده پخش خواهد شد که شامل تجسم مناظر زیبا و خوشایند (ساحل دریا) و تلقینات مثبت مرتبط با افزایش سلامتی می باشد. گروه کنترل مراقبت های روتین را دریافت می کنند. در پایان، مجدداً پرسشنامه اشپیل برگر برای هر دو گروه تکمیل می گردد. امید است که در صورت مؤثر بودن این روش بتوان آن را به عنوان یک روش درمانی کاهنده اضطراب توسط پرستاران مورد استفاده قرار داد.
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    The aim of this study was to determine the effect of mental imagery on anxiety in patients before abdominal surgery.
    empty
    هدف از انجام این مطالعه تعیین تأثیر تصویرسازی ذهنی بر میزان اضطراب بیماران قبل از اعمال جراحی شکم می باشد
    empty
    This clinical trial study was conducted with parallel group, randomized design.
    empty
    این مطالعه کارآزمایی بالینی با طرح موازی تصادفی شده است.
    empty
    In this randomized clinical trial, 116 patients undergoing appendectomy and herniorrhaphy at Sabzevar Beheshti Hospital in 2014 will be randomly assigned to intervention and control groups.
    empty
    ر این کارآزمایی بالینی تصادفی شده، 116بیمار کاندید عمل جراحی آپاندکتومی و هرنیورافی، بستری در بیمارستان شهید بهشتی سبزوار در سال 1392 به صورت تصادفی به دو گروه مداخله و کنترل تقسیم خواهند شد.
    empty
    Some of inclusion criteria included: patients 15 to 49 years old; abdominal surgery (appendicitis and hernia requiring surgical intervention); having full consciousness
    empty
    برخی از معیارهای ورود عبارتند از: بیماران 15 تا 49 ساله؛ اعمال جراحی شکم (آپاندیسیت و هرنی نيازمند به مداخله جراحي)؛ داشتن هوشیاری کامل.
    empty
    Intervention group: 18-minute mental imagery CD will be played through headphones, which include visualization of the beautiful scenery and pleasant (the beach) and positively associated with increased wellness is empathy. The control group received routine care.
    empty
    برای افراد گروه مداخله، 18 دقیقه از طریق هدفون سی دی تصویرسازی ذهنی پخش خواهد شد که شامل تجسم مناظر زیبا و خوشایند (ساحل دریا) و تلقینات مثبت مرتبط با افزایش سلامتی می باشد. گروه کنترل مراقبت های روتین را دریافت می کنند.
    empty
    anxiety
    empty
    اضطراب
  • General information

    The Effect of Guided Imagery on Anxiety
    The Effect of Mental Imagery on Anxiety
    تأثیر تجسم هدایت شده بر اضطراب
    تأثیر تصویرسازی ذهنی بر اضطراب
    The Effect of Guided Imagery on Preoperative Anxiety in Patients Undergoing Abdominal Surgery
    The Effect of Mental Imagery on Preoperative Anxiety in Patients Undergoing Abdominal Surgery
    بررسی تأثیر تجسم هدایت شده بر میزان اضطراب بیماران قبل از اعمال جراحی شکم
    بررسی تأثیر تصویرسازی ذهنی بر میزان اضطراب بیماران قبل از اعمال جراحی شکم
    patients 15 to 49 years old
    abdominal surgery (appendicitis and hernia requiring surgical intervention)
    having full consciousness
    loss of hearing
    loss of hearing; having a stressful event (divorce, death of spouse or close relative, loss of a job, migration, severe accident) during the last 6 months
    بیماران 15 تا 49 ساله
    اعمال جراحی شکم (آپاندیسیت و هرنی نيازمند به مداخله جراحي)
    داشتن هوشیاری کامل
    فقدان مشکل شنوایی
    نداشتن حادثه استرس زا (طلاق، فوت همسر و وابستگان نزدیک، از دست دادن شغل، مهاجرت، تصادف شدید) طی 6 ماه گذشته.
    empty
    Random assignment using random blocks
    empty
    تخصیص تصادفی با استفاده از بلوک های تصادفی
    empty
    empty
    empty
    empty
  • Recruitment centers

    #1
    Name of recruitment center - English: Sabzevar Beheshti Hospital
    Name of recruitment center - Persian: بیمارستان بهشتی سبزوار
    Full name of responsible person - English: Mahbobe Mohebbi
    Full name of responsible person - Persian: محبوبه محبی
    Street address - English: Razi Street
    Street address - Persian: خیابان رازی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Sabzevar Beheshti Hospital
    Name of recruitment center - Persian: بیمارستان بهشتی سبزوار
    Full name of responsible person - English: Mahbobe Mohebbi
    Full name of responsible person - Persian: محبوبه محبی
    Street address - English: Razi Street
    Street address - Persian: خیابان رازی
    City - English: Sabzevar
    City - Persian: Sabzevar
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 51 4442 8257
    Fax:
    Email: mohebbi_mhb@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mr. Moosareza Tadayonfar
    Full name of responsible person - Persian: آقای موسی الرضا تدین فر
    Street address - English: School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
    Street address - Persian: سبزوار، جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mr. Moosareza Tadayonfar
    Full name of responsible person - Persian: آقای موسی الرضا تدین فر
    Street address - English: School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
    Street address - Persian: سبزوار، جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 51 4442 8257
    Fax:
    Email: mohebbi_mhb@yahoo.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mahbobe Mohebbi
    Full name of responsible person - Persian: محبوبه محبی
    Position - English: Senior student of Nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
    Street address - Persian: سبزوار، جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 51 1386 1959
    Mobile: +98 937 609 3917
    Fax:
    Email: mohebbi_mhb@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mahbobe Mohebbi
    Full name of responsible person - Persian: محبوبه محبی
    Position - English: Senior student of Nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery, next to the SHahroud road police station
    Street address - Persian: جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 51 1386 1959
    Mobile: +98 937 609 3917
    Fax:
    Email: mohebbi_mhb@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mr Moosareza Tadayonfar, Faculty Member of Sabzevar University of Medical Science
    Full name of responsible person - Persian: آقای موسی الرضا تدین فر، عضو هیئت علمی دانشگاه سبزوار
    Position - English: Master of nursing
    Position - Persian: کارشناس ارشد پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
    Street address - Persian: سبزوار، جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 57 1444 6070
    Mobile: 00
    Fax:
    Email: mtadayonfar@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mr Moosareza Tadayonfar, Faculty Member of Sabzevar University of Medical Science
    Full name of responsible person - Persian: آقای موسی الرضا تدین فر، عضو هیئت علمی دانشگاه سبزوار
    Position - English: Master of nursing
    Position - Persian: کارشناس ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery, next to the SHahroud road police station
    Street address - Persian: جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 57 1444 6070
    Mobile: +98 919 882 9193
    Fax:
    Email: mtadayonfar@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mahbobe Mohebbi
    Full name of responsible person - Persian: محبوبه محبی
    Position - English: senior student of Nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Next to the police station to SHahroud road, Sabzevar.
    Street address - Persian: سبزوار، جنب پلیس راه شاهرود
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 57 1444 6070
    Mobile: +98 937 609 3917
    Fax:
    Email: mohebbi_mhb@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mahbobe Mohebbi
    Full name of responsible person - Persian: محبوبه محبی
    Position - English: senior student of Nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery, next to the SHahroud road police station
    Street address - Persian: جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 51 4442 8257
    Mobile: +98 937 609 3917
    Fax:
    Email: mohebbi_mhb@yahoo.com
    Web page address:
  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Not decided yet...
    empty
    هنوز تصمیم نگرفته ام

Protocol summary

Study aim
The aim of this study was to determine the effect of mental imagery on anxiety in patients before abdominal surgery.
Design
This clinical trial study was conducted with parallel group, randomized design.
Settings and conduct
In this randomized clinical trial, 116 patients undergoing appendectomy and herniorrhaphy at Sabzevar Beheshti Hospital in 2014 will be randomly assigned to intervention and control groups.
Participants/Inclusion and exclusion criteria
Some of inclusion criteria included: patients 15 to 49 years old; abdominal surgery (appendicitis and hernia requiring surgical intervention); having full consciousness
Intervention groups
Intervention group: 18-minute mental imagery CD will be played through headphones, which include visualization of the beautiful scenery and pleasant (the beach) and positively associated with increased wellness is empathy. The control group received routine care.
Main outcome variables
anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2013122315905N1
Registration date: 2014-05-27, 1393/03/06
Registration timing: retrospective

Last update: 2019-06-10, 1398/03/20
Update count: 1
Registration date
2014-05-27, 1393/03/06
Registrant information
Name
Mahbobe Mohebbi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1386 1959
Email address
mohebbi_mhb@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mental Imagery on Preoperative Anxiety in Patients Undergoing Abdominal Surgery
Public title
The Effect of Mental Imagery on Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients 15 to 49 years old abdominal surgery (appendicitis and hernia requiring surgical intervention) having full consciousness loss of hearing loss of hearing; having a stressful event (divorce, death of spouse or close relative, loss of a job, migration, severe accident) during the last 6 months
Exclusion criteria:
Age
From 15 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 116
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment using random blocks
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
Sabzevar University of Medical Sciences
Street address
Next to the police station to Shahroud road, Sabzevar.
City
Sabzevar
Province
Razavi Khorasan
Postal code
0000000000
Approval date
2013-11-13, 1392/08/22
Ethics committee reference number
medsab.Rec.92.1

Health conditions studied

1

Description of health condition studied
Anxiety before abdominal surgery
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Preoperative Anxiety
Timepoint
Before surgery
Method of measurement
Spielberger Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
In addition to routine care, interventional group listened to guided imagery audio CD, one hour before surgery for 18 minutes.
Category
Other

2

Description
Control group received only routine care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Beheshti Hospital
Full name of responsible person
Mahbobe Mohebbi
Street address
Razi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 4442 8257
Email
mohebbi_mhb@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mr. Moosareza Tadayonfar
Street address
School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
City
Sabzevar
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 4442 8257
Email
mohebbi_mhb@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mahbobe Mohebbi
Position
Senior student of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, next to the SHahroud road police station
City
Sabzevar
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 1386 1959
Fax
Email
mohebbi_mhb@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mr Moosareza Tadayonfar, Faculty Member of Sabzevar University of Medical Science
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, next to the SHahroud road police station
City
Sabzevar
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 57 1444 6070
Fax
Email
mtadayonfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mahbobe Mohebbi
Position
senior student of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, next to the SHahroud road police station
City
Sabzevar
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 4442 8257
Fax
Email
mohebbi_mhb@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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