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The impact of guided imagery-based counseling on the quality of life of women with polycystic ovary syndrome

Protocol summary

Study aim
The aim of the study is to determine the effectiveness of guided imagery on hirsutism, weight, anxiety, and stress related to infertility, menstrual disorders, emotional issues, and quality of life in women with polycystic ovary syndrome.
Design
A clinical trial with a control group, parallel groups, double-blind, randomized, conducted on 66 patients.
Settings and conduct
In healthcare centers, both public and private, in Ramhormoz County, including the Women's Clinic of Mother Hospital and private offices of midwives and gynecologists, consultations will be held. Counseling sessions will be conducted in the researcher's private office.
Participants/Inclusion and exclusion criteria
**Inclusion Criteria for the Study:** 1. Age between 18 and 35 years 2. Diagnosed cases of Polycystic Ovary Syndrome (PCOS) based on Rotterdam criteria 3. At least two years after menarche 4. A score higher than 26 on the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ) 5. Ability to participate in 8 educational classes 6. Literacy in reading and writing 7. Proficiency in Persian.
Intervention groups
The intervention group will receive guided imagery education to examine its effect on the quality of life of women with polycystic ovary syndrome (PCOS).
Main outcome variables
"Consultation based on guided visualization, quality of life, age, education, marital status, employment and economic status, infertility, number of children."

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241026063502N1
Registration date: 2025-02-14, 1403/11/26
Registration timing: registered_while_recruiting

Last update: 2025-02-14, 1403/11/26
Update count: 0
Registration date
2025-02-14, 1403/11/26
Registrant information
Name
maria Ahmadirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4352 7510
Email address
mariaahmadirad0@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-11, 1403/10/22
Expected recruitment end date
2025-03-12, 1403/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of guided imagery-based counseling on the quality of life of women with polycystic ovary syndrome
Public title
the effect of guided imagery on the quality of life of women with polycystic ovary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years Known cases of polycystic ovary syndrome based on Rotterdam criteria At least two years since menarche A score of more than 26 on the quality of life questionnaire for women with polycystic ovary syndrome( PCOSQ) The ability to attend 8 training sessions Having literacy skills ( reading and writing) Proficiency in the Persian language
Exclusion criteria:
Diagnosed physical health problems and diseases Use of psychiatric medications addiction to drugs and alcohol Simultaneous use of other relaxation methods Pregnancy and breastfeeding The occurrence of stress-related events in the past three months (Death of a relative, divorce...)
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals in the research community who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to two groups: intervention (33 individuals) and control (33 individuals) using a random number table. The allocation of intervention to individuals will be done randomly using a randomized block design with block sizes of 4, 6, and 8 (utilizing a table of random permutations). The randomization list will be prepared by a statistician. The intervention used in this study will be allocated according to the randomized list by an individual outside the study, who is unaware of the research goals, based on the corresponding codes in sealed envelopes.
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
Jundishapur University of Medical Sciences, Ahvaz
Street address
Golestan highway-Jandishapur University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-12-21, 1403/10/01
Ethics committee reference number
IR.AJUMS.REC.1403.509

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
quality of life
Timepoint
"Before starting the study, immediately after, and two weeks after the end of the counseling sessions."
Method of measurement
:Data collection tools include: A: Demographic information questionnaire, which includes personal, medical, and obstetric information such as age, marital status, body mass index, education level of the individual and spouse, employment status of the individual and spouse, number of children, and history of infertility of the individual. B: Quality of life questionnaire for women with polycystic ovary syndrome (PCOSQ).

Secondary outcomes

empty

Intervention groups

1

Description
The test group will undergo eight sessions of group counseling based on guided visualization, led by a researcher who has previously completed a guided visualization counseling course under the supervision of a thesis advisor. After the sessions, they will be provided with a checklist to record the date and time of their exercises daily, marking their progress in the corresponding table. This table will be reviewed weekly by the researcher. The counseling sessions will be held in person for 45 minutes in groups of 5 to 6 participants. The content of the counseling sessions will be derived from relevant sources, supported by research, and developed in consultation with a psychology advisor. The most common duration for psychological interventions is 20 minutes, and the guided visualization sessions will consist of two main parts: 1) relaxation and 2) receiving guided visualization. Initially, relaxation will take place for 10 minutes, followed by the exercise for 20 minutes. After this, participants will share their experiences with their peers for 10 minutes, followed by a 5-minute Q&A session. Participants are asked to practice the techniques presented in each session for 20 minutes a day, six days a week.
Category
Treatment - Other

2

Description
Control group: During the research period, no intervention will be done for the control group and they will continue with their daily activities, and in order to appreciate them and in terms of observing the ethical principles, at the end of the research, we will provide them with guided visualization educational pamphlets and a two-hour counseling session based on guided visualization for free.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother hospital
Full name of responsible person
Ismail Jamshid Nejad
Street address
Moalem boulevard
City
Ramhormoz
Province
Khouzestan
Postal code
6381651154
Phone
+98 61 4352 2130
Email
name@rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnosh Zaker Kish
Street address
Jundi Shapur University، Golestan Boulevard، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
eduaum@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maria Ahmadirad
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 1، 15 Narges Alley، Farhangian Phase 4
City
Ramhormoz
Province
Khouzestan
Postal code
6381766927
Phone
+98 61 4352 7511
Email
maria.ahmadirad123@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maria Ahmadirad
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 1، 15 Narges Alley، Farhangian Phase 4
City
Ramhormoz
Province
Khouzestan
Postal code
6381766927
Phone
+98 61 4352 7510
Email
maria.ahmadirad123@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maria Ahmadirad
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 1، 15 Narges Alley، Farhangian Phase 4
City
Ramhormoz
Province
Khouzestan
Postal code
6381766927
Phone
+98 61 4352 7510
Email
maria.ahmadirad123@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data includes information about the main outcome of the sharing.
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
Researchers working in the university institute
Under which criteria data/document could be used
via email
From where data/document is obtainable
Email address: maria.ahmadirad123@gmail.com
What processes are involved for a request to access data/document
Apply by email
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