Comparing the effectiveness of midwife-led integrative couple counseling with routine care on sexual desire discrepancy in couples after their delivery
Comparing the effectiveness of midwife-led integrative couple counseling with routine care on sexual desire discrepancy in couples after their delivery
Design
A randomized controlled clinical trial with two parallel intervention and control arms
Settings and conduct
Visiting health centers, urban family doctor and selected gynecologists' offices, identifying eligible people, dividing patients into two intervention and control groups randomly, completing questionnaires by both groups, evaluating results using Porsline through the network Eitaa or WhatsApp social media will be done.
Participants/Inclusion and exclusion criteria
Declaration of written consent of both couples to participate in the study/ women of childbearing age / at least 10 weeks have passed after their delivery / return of menstruation / living with a spouse / access to a smartphone (to complete the form and questionnaires in the Porsline) / availability in length of the study / No other chronic physical diseases / No addiction / No pregnancy / No mental disorders (depression, anxiety and stress based on the DASS-21 questionnaire) or physical diseases that interfere with their daily functioning/ No consumption Psychiatric drugs/ lack of participation in educational and counseling courses related to improving sexual function in the last 6 months/ lack of history of genital or pelvic surgeries (such as hysterectomy) that affect their sexual desire.
Intervention groups
Couple counseling sessions will be conducted in 5 sessions of 60 minutes at an interval of one week. Control group: In addition to routine midwifery care, after completing the study, a pamphlet containing educational materials will be provided to them during a session.
Main outcome variables
Sexual desire discrepancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031117N17
Registration date:2024-11-12, 1403/08/22
Registration timing:prospective
Last update:2024-11-12, 1403/08/22
Update count:0
Registration date
2024-11-12, 1403/08/22
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of midwife-led integrative couple counseling with routine care on sexual desire discrepancy in couples after their delivery
Public title
The effectiveness of integrative couple counseling on sexual desire discrepancy after delivery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Declaration of written consent of both couples to participate in the study
Women of childbearing age
At least 10 weeks have passed after their delivery
Return of menstruation
Living with a spouse
Access to a smartphone (to complete the form and questionnaires in the Porsline)
Availability in Length of the study
Exclusion criteria:
Other chronic physical diseases
Addiction
Pregnancy
Suffering from mental disorders (depression, anxiety and stress based on the DASS-21 questionnaire) or physical diseases that interfere with their daily functioning.
Consumption Psychiatric drugs
Participating in educational and counseling courses related to improving sexual function in the last 6 months
History of genital or pelvic surgeries (such as hysterectomy) that affect their sexual desire
Age
From 18 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples are matched based on the duration of marriage, the number of births and breastfeeding, and the block method will be used for the random allocation of the samples. For this purpose, two blocks will be considered. Two possible blocks are TC and CT, where T is for the intervention group and C is for the control group. The numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in domain 1 and 2) And according to the production values of one of the blocks (production number 1 for CT block , production number 2 for TC blocks) will be selected and samples will be allocated. The sampling method will be done in convenience method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of the consequences will be done using the PORSLINE through the social networks Eitaa or WhatsApp. The researcher and the evaluator do not know the group to which the participant belongs when evaluating the outcome.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Moalem Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2024-10-01, 1403/07/10
Ethics committee reference number
IR.MAZUMS.REC.1403.304
Health conditions studied
1
Description of health condition studied
sexual desire discrepancy of couples
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
sexual desire discrepancy of couples
Timepoint
Determining the sexual desire discrepancy of couples before, immediately and 4 weeks after the intervention
Method of measurement
Using Halbert Sexual Desire Questionnaire, the sexual desire score of each couple will be calculated. The couple's desire discrepancy scores will be calculated as the difference between the couple's sexual desire scores in the Halbert questionnaire, after standardization. That is, men's Z score from women's Z score will be reduced. For the discrepancy to be significant, the absolute value of the Z score with a 95% confidence interval should be greater than 1.96.
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Determining the sexual satisfaction of couples before, immediately and 4 weeks after the intervention
Method of measurement
Larson's standard sexual satisfaction questionnaire
Intervention groups
1
Description
Intervention group: Counseling sessions with the presence of couples will be conducted for an average of 60 minutes and during 5 sessions with an interval of one week. People will be contacted once or twice a week to ensure that they complete their assignments. Immediately after the completion of the intervention sessions, there will be a post-test and a session to follow up and re-evaluate the two groups in terms of the couples' sexual desire discrepancy and sexual satisfaction, four weeks later.
Category
Behavior
2
Description
Control group: Control group: In addition to receiving routine midwifery care, after completing the study, they will be provided with a pamphlet containing educational materials about sexual desire discrepancy of couples and sexual satisfaction after delivery and solutions to improve it in a session.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers, urban family doctor bases
Full name of responsible person
Dr. Soghra Khani
Street address
Vesal Street, Amir Mazandarani Boulevard, Sari, Mazandaran Province,
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
khanisog343@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moalem square, Moalem street
City
sari
Province
Mazandaran
Postal code
4816717887
Phone
+98 11 3339 8303
Fax
+98 11 3339 8303
Email
enayati@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Tousheh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hamzehkala Square
City
babol
Province
Mazandaran
Postal code
4731714576
Phone
+98 11 3234 1294
Email
f.tousheh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghra Khani
Position
PhD/ Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vasal St, Amir Mazandarani Blvd
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
khanisog343@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Tousheh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hamzehkala Square
City
Babo;
Province
Mazandaran
Postal code
4731714576
Phone
+98 11 3234 1294
Email
f.tousheh@gmail.com
Web page address
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 information related to the research is shared with the aim of keeping the names of the people and keeping their identities confidential and complying with the 31 code of ethics
When the data will become available and for how long
Since 1404
To whom data/document is available
All researchers and those interested in research
Under which criteria data/document could be used
To conduct review and supplementary research and for the use of Therapists and counselors of couples' sexual disorders
From where data/document is obtainable
In order to receive documents or data, the corresponding author can be reached by email at khanisog343@gmail.com and counseling student in midwifery at f.tousheh@gmail.com. If the article is published according to the journal address, you can refer to that journal.
What processes are involved for a request to access data/document
First, you should send an email to the responsible author of the article and make your request, and if the responsible author and the research team deem it appropriate, the documents and files will be provided in a short period of time.