Evaluation of the effectiveness of mindfulness-based counseling on sexual satisfaction and performance in women with polycystic ovary syndrome(PCO)
Design
The method of random block allocation is divided into two groups of intervention and control (4 blocks). The sample size of people in group therapy with mindfulness approach should not exceed 14 people, because the effectiveness of psychotherapy decreases with increasing sample size , so the intervention group was divided into three groups of 9 patients and control group of 27 people.
Settings and conduct
.Altered performance and sexual satisfaction in people with PCO
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 55 years
Married
BMI less than 30
Diagnosis of polycystic ovary syndrome based on Rotterdam criteria
Score less than 26.5 from the Sexual Function Questionnaire
Score less than 75 on the Sexual Satisfaction Questionnaire
6 months have passed since the start of treatment.
Do not be treated with infertility drugs
No entry conditions:Having a specific physical and mental illnessAddiction to alcohol, drugs and other psychotropic drugs
Having sexual dysfunction in yourself and your spouse Pregnancy and lactation
Intervention groups
The sample size of people in group therapy with mindfulness approach should not exceed 14 people, because the effectiveness of psychotherapy decreases with increasing sample size. Therefore, the intervention group was divided into three treatment groups of 9 people and the control group of 27 people. Then the intervention is performed as a pre-test, post-test so that all women in the three groups at the beginning of the study, week 8 and week 12 after the intervention questionnaire They complement Larson sex and sexual function in the form of self-report.
Main outcome variables
Altered performance and sexual satisfaction in people with pco
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049216N1
Registration date:2021-02-08, 1399/11/20
Registration timing:prospective
Last update:2021-02-08, 1399/11/20
Update count:0
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
Monire Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 7837
Email address
zmonire74@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-12, 1399/11/24
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mindfulness counseling on sexual satisfaction and function in women with polycystic ovary syndrome
Public title
The effect of Mindfulness counseling on sexual satisfaction and function in women with polycystic ovary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 55 years
Married
Have a minimum literacy rate
BMI less than 30
Diagnosis of polycystic ovary syndrome based on Rotterdam criteria (oligomenorrhea / amenorrhea, ultrasound evidence, clinical signs such as acne, hirsutism, and laboratory signs of hyperandrogenism (also recorded and diagnosed by a gynecologist)
Score less than 26.5 from the Sexual Function Questionnaire(FSFI)
Score less than 75 on the Sexual Satisfaction Questionnaire(ISS)
6 months have passed since the start of treatment
Do not be treated with infertility drugs
Exclusion criteria:
Having a specific physical and mental illness
Addiction to alcohol, drugs and other psychotropic drugs
Having sexual dysfunction in yourself and your spouse
Pregnancy and lactation
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Structuring is performed by structural block method to create a balance in the number of samples specified to each of the study groups. In this method, the measurement of blocks can be fixed or variable. In this study, we use blocks with an equal number of 4 safe. For the specific feature using the blocking method and individual characteristics into 2 intervention groups (A) and intervention group (B), there are six modes for blocks, including: AABB, ABAB, ABBA, BBAA, BABA and BAAB using The computer generates random numbers. For number 1 of combination 1 (BAAB), for number 2 of combination 2 (BBAA), for number 3 of combination 3 (ABBA), for number 4 of combination 4 (ABAB), for number 5 of combination 5 (BAAB) and For number 6, use combination 6 (AABB).
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 Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan Boulevard
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.AJUMS.REC.1399.623
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function
Timepoint
Evaluation of sexual function and satisfaction before the intervention and in week 8 and week 12 after the intervention
Method of measurement
FSFI Sexual Function Questionnaire(FSFI)
2
Description
Sexual Satisfaction Questionnaire
Timepoint
Evaluation of sexual function and satisfaction before the intervention and in week 8 and week 12 after the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group will receive 8 sessions of cognitive counseling based on group mindfulness for 120 minutes once a week on a specific day. The sessions will be held by a researcher who has received the necessary training and certification in mindfulness-based cognitive counseling, and the counselor will attend some sessions to ensure the correctness of the intervention, and finally take a post-test after the sessions. will be.
Category
Treatment - Other
2
Description
Control group: Due to the fact that the control group did not receive any intervention despite sexual and marital dissatisfaction. In order to make the research ethical, after completing the study, an educational booklet and a summary of the contents of the sessions are given to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadan Shahid Beheshti Hospital Clinic
Full name of responsible person
Monire zarei
Street address
Ahmadabad Street
City
َAbadan
Province
Khouzestan
Postal code
6316648371
Phone
+98 61 5332 3094
Email
zmonire74@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghadam
Street address
Golestan Boulevard
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3336 1968
Email
zmonire74@yahoo.com
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
Mitra Tadayon
Position
Faculty of Ahvaz University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3336 1968
Email
tadayon-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Monire Zarei
Position
Master student of Dermatology Consulting
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kave
City
Isfahan
Province
Isfehan
Postal code
8138795846
Phone
+98 31 3345 7837
Email
zmonire74@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Monire Zarei
Position
Master student of midwifery Consulting
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kave
City
Isfahan
Province
Isfehan
Postal code
8138795846
Phone
+98 31 3345 7837
Email
zmonire74@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available