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Effectiveness of Good-Enough Sex (GES) model-based group counseling on sexual self-concept and sexual quality of life in postpartum primiparous women

Protocol summary

Study aim
Comparison average score changes of sexual self-concept and sexual quality of life of primiparous women after childbirth before and after the intervention in two intervention and control groups
Design
A randomized and unblinded controlled clinical trial with 2 arm parallel group design of 120 people, using Random allocation software.
Settings and conduct
Before the intervention, questionnaires of personal information, sexual self-concept, sexual quality of life and DASS-21 scale are completed by the research units. Immediately and after 2 months from the last session, the questionnaire of sexual self-concept and sexual quality of life will be completed and will be followed up online.
Participants/Inclusion and exclusion criteria
Primiparous women in 2 to 6 months after childbirth, 18 to 35 years old, Recent delivery was non-traumatic and the result is a healthy singleton baby, Being married and the only wife of her husband, Currently living with her husband and have resumed her sexual relationship after childbirth, Not suffering from chronic diseases affecting sexual issues and severe psychiatric diseases, Not taking drugs affecting sexual function by woman or her husband, Not suffering from sexual disorders in the husband and Not suffering from severe depression, anxiety and stress.
Intervention groups
In the intervention group, group counseling is held during 4 sessions, one session of 60-90 minutes per week in the counseling room of the center. Also, the educational content for the spouses, which is appropriate to the topics of each counseling session, has been prepared and will be provided to them in a textual and multimedia form through the channel in the Eitaa messengers. In addition, there are tasks for couples to do in between sessions. The control group also receives routine health care from the health center.
Main outcome variables
sexual self-concept and sexual quality of life

General information

Reason for update
Acronym
GES
IRCT registration information
IRCT registration number: IRCT20241207063966N1
Registration date: 2024-12-09, 1403/09/19
Registration timing: prospective

Last update: 2024-12-09, 1403/09/19
Update count: 0
Registration date
2024-12-09, 1403/09/19
Registrant information
Name
Fateme Hajiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3357 3318
Email address
hajianf4012@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-01-09, 1403/10/20
Expected recruitment end date
2025-08-21, 1404/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Good-Enough Sex (GES) model-based group counseling on sexual self-concept and sexual quality of life in postpartum primiparous women
Public title
Effectiveness of Good-Enough Sex (GES) model-based group counseling on sexual self-concept and sexual quality of life in postpartum primiparous women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having written consent to participate in the study Having the least reading and writing literacy Primiparous women in 2 to 6 months after childbirth Having Iranian citizenship 18 to 35 years old Her recent delivery was non-traumatic and the result is a healthy singleton baby Being married and the only wife of her husband Currently living with her husband and have resumed her sexual relationship after childbirth (having sex at least once or twice a week)
Exclusion criteria:
Suffering from chronic diseases affecting sexual issues Addiction to alcohol, drugs and other psychoactive drugs Suffering from severe psychiatric diseases Participating in sexual training or counseling Taking drugs affecting sexual function in a woman or her husband The presence of prostate problems and sexual disorders in the husband Have a history of pelvic surgery or radiotherapy Suffering from severe depression, anxiety and stress
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: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the selected health centers are allocated to one of two intervention and control groups using the permuted block randomization. For this purpose, one health center was selected randomly (lottery) as a cluster among the five health-treatment centers of Mashhad city, and after preparing the list of centers covered by the center, four centers were randomly selected from among the centers that have a consultation room are selected. Four centers are assigned to two control and intervention groups using the permuted block randdomization with random block size and using Random Allocation Software. Sampling will be done from each center as available and based on the entry criteria. Due to the fact that the allocated centers are geographically independent and far from each other, there is no possibility of information leakage. Considering that the intervention is a consultation model and the possibility of publishing information in this study, the centers are assigned to two groups, and the individuals (subjects) of each center are assigned to one of the groups, and concealment is not done for individuals.
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 Mashhad University of Medical Sciences
Street address
Baharestan dormitory, Hejab Blvd, Bahonar Blvd, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948958
Approval date
2024-10-15, 1403/07/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.072

Health conditions studied

1

Description of health condition studied
sexual health
ICD-10 code
F52.8
ICD-10 code description
Other sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
Sexual self-concept score based on MSSCQ questionnaire
Timepoint
At the beginning of the study (before the implementation of the intervention), immediately and 2 months after the last session of the intervention
Method of measurement
Snell sexual self-concept questionnaire

2

Description
Sexual quality of life score based on SQOL-F questionnaire
Timepoint
At the beginning of the study (before the implementation of the intervention), immediately and 2 months after the last session of the intervention
Method of measurement
Symonds sexual quality of life questionnaire

Secondary outcomes

1

Description
Sexual function score based on FSFI questionnaire
Timepoint
At the beginning of the study (before the implementation of the intervention), immediately and 2 months after the last session of the intervention
Method of measurement
Rosen sexual function questionnaire (FSFI)

Intervention groups

1

Description
Intervention group: Intervention group: At first, the questionnaires of personal information, sexual self-concept, sexual quality of life and DASS-21 scale are completed by the research units. Then, in the counseling group based on the GES model, group counseling is held during 4 sessions, one session of 60 to 90 minutes per week in the counseling room of the center. The content of the intervention included: First session "Implementation of the first three aspects of GES model- Explaining the importance of sex as a Crucial element of life- The importance of quality of sex and sexual satisfaction in the sexual development of couples Setting realistic expectations for sexual relations", Second session "Implementation of the fourth, fifth and sixth dimensions of GES models- Emphasis on physical health and healthy habits for reviving sexual health- Behavioral training and counseling(mindfulness)- Paying equal attention to gaining sexual pleasure as much as achieving proper sexual function", Third session "Implementation of the seventh, eighth and ninth dimensions of the GES model- Counseling to overcome sexual fears and worries- Training to have flexible sexual experiences- Letting go of idealistic ideas about sex- Defining objectives in sex- Getting familiar with sexual arousal styles" and Forth Session "Implementation of the tenth, eleventh and twelfth dimensions of the GES model- Getting familiar with gender differences and acceptance of similarities and differences- Strengthening communication skills- Sexual desire cycle training and counseling to personalize sexual desire". In the interval between the sessions, the participants are required to complete the tasks assigned for each session. Since the GES model is designed with a focus on couples' relationships, it is necessary to involve spouses in this intervention. Therefore, this is done in two ways: 1. Preparation of educational content for spouses that is appropriate to the educational-counseling titles of each counseling session and will be provided to them in a textual and multimedia form through the channel in Eitaa messenger. 2. Preparation of homework for couples, which requires the participants to share the contents of the counseling sessions with their spouses, and in this way, information transfer and dialogue between couples is done, which is part of the intervention tasks. Finally, immediately and after 2 months from the last session, the research units will complete the Snell's sexual self-concept questionnaire and Simmonds' sexual quality of life questionnaire and will be followed up online. In order to prevent samples from falling and respond to their treatment problems, the researcher will be in regular contact with people through Eitaa messenger between visits. In this way, this communication will be based on the needs of the participant and if سhe wants and needs, a phone call will be arranged for him. In addition, in order to organize this matter, the researcher will allocate a certain time every day for this work. Also, from the beginning of the intervention, a public group will be created in Eitaa messenger for the participants to ask non-personal questions, including issues related to the intervention, assignments and notifications.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad health center
Full name of responsible person
Hamidreza Ghorbanzade
Street address
Felestin 25 Alley, Felestin Blvd., Malekabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3841 5001
Email
Health@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fateme Hajiabadi
Street address
Shahid Kharazmi educational complex, University Complex, East gate of Mashhad Ferdosi university, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Rahele Babazade
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Faculty, Shahid Kharazmi educational complex, University complex, East gate of Ferdosi university, Azadi square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
Babazadehr@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rahele Babazade
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Faculty, Shahid Kharazmi educational complex, University complex, East gate of Ferdosi University, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
Babazadehr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Hajiyan
Position
Master science student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Baharestan dormitory, Hejab Blvd., Bahonar Blvd., Vakilabad Blvd.
City
Mashhaad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3884 6730
Email
Hajianf4012@mums.ac.ir

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
The data in the study includes sexual self-concept , sexual quality of life, sexual performance score and demographic and fertility characteristics. These data will be reported only in the form of numbers and the average score, and the names of the participants are confidential to the researcher.
When the data will become available and for how long
The start of access will be along with the publication of articles related to the thesis.
To whom data/document is available
Access to the thesis will be free for researchers and medical students of Mashhad, and access to related articles will be free for all researchers.
Under which criteria data/document could be used
People affiliated with scientific organizations can use these items for their studies upon request, respecting the right of ownership of information and referring to the relevant study.
From where data/document is obtainable
By email to the corresponding author
What processes are involved for a request to access data/document
After receiving the applicant's email, including his/her introduction and the type of application to the responsible author, the required information will be checked and sent as soon as possible.
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