The effect of marital relationship enrichment counseling compared to usual treatment on the quality of life, performance and sexual satisfaction of women with endometriosis
Investigating the impact of marital relationship enrichment counseling on the quality of life, performance and sexual satisfaction of women with endometriosis
Design
A clinical trial with a control group, with parallel groups, single blind, randomized using a card, will be conducted on 44 patients.
Settings and conduct
1- Location of the study: Endometriosis clinic of the hospital affiliated to Qom University of Medical Sciences is the research environment of this study.
2- Study population: women with endometriosis
3- Type of blinding: only blinding of the statistician will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years; married; Diagnosis of endometriosis by a gynecologist; At least two years of living together have passed; At least six months have passed since the diagnosis, treatment and stabilization of the disease.
Exclusion criteria: history of severe marital disputes and going to court; couple's addiction to drugs; Experiencing recent crises in life; history of psychiatric disorders; History of participating in psychological training classes with the aim of improving sexual problems
Intervention groups
Intervention group: The intervention to enrich couples' relationships will take place during six 90-minute sessions in the form of couple counseling with the presence of the patient and his wife.
Control group: The control group will receive only regular programs.
Main outcome variables
Sexual performance; Sexual satisfaction; Sexual life quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231229060565N1
Registration date:2024-02-18, 1402/11/29
Registration timing:prospective
Last update:2024-02-18, 1402/11/29
Update count:0
Registration date
2024-02-18, 1402/11/29
Registrant information
Name
Zohre Momenimovahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3662 6132
Email address
zmomeni@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of marital relationship enrichment counseling compared to usual treatment on the quality of life, performance and sexual satisfaction of women with endometriosis
Public title
Effect of counseling on Sexual life quality, sexual function and sexual satisfaction in patient with endometriosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years of age
married
diagnosed with endometriosis by a gynecologist
at least two years of cohabitation
at least six months of diagnosis, treatment and stabilization of the disease
Exclusion criteria:
Simultaneous participation in another study
History of participating in psychological training classes with the aim of improving sexual problems
History of psychiatric disorders
Experiencing recent crises in life
Addiction of couples to drugs
History of severe marital disputes and going to court
Age
From 18 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, people are randomly assigned to two intervention and control groups. In this method, a number of cards are considered as the first group and the same number of cards for the next groups; Then, by mixing the cards together, one card is issued and its allocation is recorded, and that card is returned to the box containing other cards after being issued. Then the cards are mixed again and another card is taken out. This process continues until reaching a random sequence according to the sample size.
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
Research Ethics Committees of Qom University of Medical Sciences
Street address
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
City
Qom
Province
Ghoum
Postal code
3715835155
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.MUQ.REC.1402.190
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Quality of sexual life
Timepoint
Before, immediately and three months after participating in the meetings in two intervention and control groups
Method of measurement
women's sexual life quality questionnaire
2
Description
Sexual performance
Timepoint
Before, immediately and three months after participating in the meetings in two intervention and control groups
Method of measurement
women's sexual performance scale
3
Description
sexual satisfaction
Timepoint
Before, immediately and three months after participating in the meetings in two intervention and control groups
Method of measurement
Larson's sexual satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Couples relationship enrichment intervention will take place during six 90-minute sessions. The executive protocol of marital relationship enrichment sessions (RET) will be conducted in the form of couple counseling and in the presence of husband and wife, and the enrichment package will be based on similar interventions taken from two treatment books based on communication enrichment and the book of sex education sessions taken from my wife's book with comments from Specialists will be specially designed.
Category
Lifestyle
2
Description
Control group: The control group receives only the usual treatments.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Endometriosis Clinic of Women's Hospital affiliated to Qom University of Medical Sciences
Full name of responsible person
Zohre Khalajinia
Street address
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 912 251 6033
Email
zkh6033@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Khalajinia
Street address
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 912 251 6033
Email
zkh6033@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Momenimovahed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 912 758 2479
Email
momeni.z@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Khalajinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 912 251 6033
Email
zkh6033@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Momenimovahed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 912 758 2479
Email
momeni.z@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Still undecided - no release schedule yet
When the data will become available and for how long
Still undecided - no release schedule yet
To whom data/document is available
People working in scientific and research institutions
Under which criteria data/document could be used
If all group members agree, the file can be accessed
From where data/document is obtainable
Dr Zohre Khalajinia
What processes are involved for a request to access data/document
The applicant should send an email to Dr. Khaljinia. It will be sent if agreed