Protocol summary

Study aim
Investigate the effect of sensate focus techniques and body image counseling on the sexual function of women with PCOS.
Design
60 married women with PCOS will be selected and randomly assigned to intervention and control groups using block randomization (in blocks of four).
Settings and conduct
Demographic questionnaires of fertility and concern about body image and sexual performance were completed by 60 eligible married women in obstetrics and gynecology offices in Yazd city. Then, people are randomly divided into intervention and control groups.The intervention group receives a face-to-face counseling session including sensory focus technique training and body image improvement. This two-hour workshop is held individually in a confidential room and the training booklet is also provided to the samples.The evaluation of the research units is done one and two months after the intervention by completing the questionnaires in person.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women aged 18-40؛ Having sex in the last 8 weeks؛ Having no known underlying disease except PCOS؛ Not having a mental illness؛ Literacy in reading and writing Persian language؛ Being Iranian؛ Exit criteria:Couples' addiction to drugs and alcohol; Stressful event in the past month; History of pelvic floor surgery; Use of medications affecting sexual function
Intervention groups
The intervention group will receive an in-person training session that includes sensory focus techniques and body image improvement along with slides and educational videos. This two-hour workshop will be conducted individually in a private room, and an educational handout will also be provided to the participants. The control group will not receive any intervention.
Main outcome variables
Sexual function, body image

General information

Reason for update
Acronym
Pcos
IRCT registration information
IRCT registration number: IRCT20241121063792N1
Registration date: 2025-03-18, 1403/12/28
Registration timing: prospective

Last update: 2025-03-18, 1403/12/28
Update count: 0
Registration date
2025-03-18, 1403/12/28
Registrant information
Name
Mahla Payam askari
Name of organization / entity
Tarbiat modares University
Country
Iran (Islamic Republic of)
Phone
+98 35 3842 5778
Email address
mahla.payamaskari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sensate focus technique and body image counseling on the sexual function of married women of reproductive age with polycystic ovarian syndrome: a Randomized Clinical Trial
Public title
Investigating the effect of sensate focus technique and body image counseling on the sexual function of married women of reproductive age with polycystic ovarian syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 18-40 Having sex in the last 8 weeks Having no known underlying disease other than PCOS Not having a mental illness Being single and living with a spouse now and during the study Literacy in reading and writing Farsi language Being Iranian
Exclusion criteria:
Addiction of couples to drugs and alcoholic beverages Stressful incident in the past month History of pelvic floor surgery Use of medications that affect sexual performance
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using a **block randomization** method to ensure balance between the intervention and control groups. In this study, blocks of four will be used, meaning that within each block, two participants will be assigned to the intervention group and two to the control group. All possible balanced sequences within a four-person block (IICC, ICIC, ICCI, CCII, CICI, CIIC) will be pre-generated. These sequences will then be randomly selected(Using a standard table of random numbers) and placed in sealed envelopes to maintain allocation concealment. Participants will sequentially select one of these envelopes, determining their group assignment, while group allocation will remain concealed from both researchers and participants until the end of the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
No

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasser Bridge, Jalal Al Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2025-01-25, 1403/11/06
Ethics committee reference number
IR.MODARES.REC.1403.149

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Sexual performance score
Timepoint
Before the intervention and one and two months after the intervention
Method of measurement
Sexual function index questionnaire

2

Description
Body image
Timepoint
Before the intervention and one and two months after the intervention
Method of measurement
Body image concern questionnare

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group receives a face-to-face counseling session including sensory focus technique training and body image improvement in the form of face-to-face counseling along with educational slides and videos, and exercises are performed for one and two months after the counseling.
Category
Treatment - Other

2

Description
Control group: will not receive an intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's office
Full name of responsible person
Mahla Payam Askari
Street address
41 Kashani St., Hafez Alley, No. 10
City
Yazd
Province
Yazd
Postal code
8915633665
Phone
+98 35 3842 5778
Email
mahlaaskari.03@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Mohammad Javan
Street address
Jalal Al Ahmad, Paul Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
mahlaaskari.03@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Mahla Payamaskari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 84, Maskan St., Banafshe Alley
City
Yazd
Province
Yazd
Postal code
8915784718
Phone
0098 35 6235152
Email
mahlaaskari.03@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mahla Payamaskari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 84, Maskan St., Banafshe Alley
City
Yazd
Province
Yazd
Postal code
8915784718
Phone
0098 35 6235152
Email
mahlaaskari.03@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mahla Payamaskari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 84, Maskan St., Banafshe Alley
City
Yazd
Province
Yazd
Postal code
8915784718
Phone
0098 35 6235152
Email
mahlaaskari.03@gmail.com

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
Not applicable
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