Protocol summary

Study aim
Investigating the effect of Couple Coping Enhancement Training on marital intimacy and quality of sexual life of married women with premenstrual syndrome and their spouses.
Design
A randomized controlled clinical trial with a simultaneous control group on 96 couples, which will be used for random allocation of quadruple blocks and random allocation sequence generation software.
Settings and conduct
Sampling in this research will be in two stages. In the first stage, Qazvin city is considered as 4 clusters in the north, south, east and west regions of Qazvin city. Then from each cluster, two centers are selected by simple random method (8 centers). In the second stage, by referring to these centers in a targeted way, the registration of qualified people with the desire to participate in the study will be done.
Participants/Inclusion and exclusion criteria
Women's inclusion criteria: •Willingness to participate in the study •Iranian and able to speak and understand Persian language •Having minimum reading and writing literacy •At least one year has passed since their marriage •Age 18 to 49 years •Having a smartphone with internet access Men's inclusion criteria: • Willingness to participate in the study • Iranian and able to speak and understand Persian language • Having minimum reading and writing literacy • At least one year has passed since their marriage • Having a smartphone with internet access
Intervention groups
Counseling sessions will be conducted in the form of 8 sessions of 45 minutes, and counseling sessions will be offered to the intervention group on virtual platforms (chosen by the participants) every two days. The control group will not receive any intervention until the end of the study, and at the end of the study, the training booklet in PDF format will be provided to the participants of both groups.
Main outcome variables
Marital intimacy, Quality of sexual life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240430061611N1
Registration date: 2024-08-10, 1403/05/20
Registration timing: prospective

Last update: 2024-08-10, 1403/05/20
Update count: 0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Faezeh Safaralinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 8442
Email address
faezeh.alinezhad1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Couple Coping Enhancement Training on marital intimacy and quality of sexual life of married women with premenstrual syndrome and their spouses.
Public title
Investigating the effect of Couple Coping Enhancement Training on marital intimacy and quality of sexual life of married women and their spouses.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women's inclusion criteria: Willingness to participate in the study Iranian and able to speak and understand Persian language Having at least reading and writing literacy At least one year has passed since their marriage Age 18 to 49 years Definitely suffering from premenstrual syndrome (premenstrual syndrome Based on the PSST scale and a score greater than 38) People whose marital intimacy score is lower than the average score (less than 68) Having a smartphone with access to the Internet Men's inclusion criteria: Willingness to participate in the study Iranian and able to speak and understand Persian language Having at least reading and writing literacy At least one year has passed since their marriage People with spouses with premenstrual syndrome Having a smartphone with internet access
Exclusion criteria:
Suffering from a mental disorder and drug use (based on self-report and health records) Taking part in other counseling sessions at the same time Couples who are on the verge of divorce The occurrence of an unfortunate incident in life during the last three months (accident, bereavement of family members) pregnancy breastfeeding
Age
From 18 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 192
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, Qazvin city is considered as 4 clusters in the north, south, east and west regions of Qazvin city. Then, from each cluster, two centers are selected by simple random method (8 centers by lottery). In the second stage, by referring to the selected health centers, the list of married women aged 18-49 years is selected from the electronic files, and the conditions of the research are mentioned during a telephone call with them. The samples will be selected from among married women with premenstrual syndrome referring to comprehensive health centers of Qazvin city and their spouses who have a low score in the marital intimacy questionnaire. We will use quadruple block design for random allocation of people. In order to determine the allocation sequence using the quadruple block method, random allocation sequence generation software will be used.By choosing 24 blocks of possible quadruples from the quadruple combination of two intervention and control groups, the selection process will be defined by default and the participants will be allocated to two groups respectively. In order to hide the sequence of allocation, the papers specifying the group of people are placed inside the envelopes in the opaque package and coded in the same order. In this case, a questionnaire with the same code will be completed for the person who receives the intervention.
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2024-08-05, 1403/05/15
Ethics committee reference number
IR.QUMS.REC.1403.183

Health conditions studied

1

Description of health condition studied
Marital intimacy
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Quality of sexual life
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Couple coping
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Marital intimacy
Timepoint
In the study "Investigation of the effect of couple coping training on marital intimacy and the quality of sexual life of married women with PMS and their spouses " Marital intimacy was measured at the beginning of the study (before the intervention), one and three months after the intervention, will be measured.
Method of measurement
In the study "Investigation of the effect of couple coping training on marital intimacy and the quality of sexual life of married women with premenstrual syndrome and their spouses", marital intimacy is measured by Walker and Thompson's 17-question questionnaire.

2

Description
Quality of sexual life
Timepoint
In the study "Investigation of the effect of couple coping training on marital intimacy and the quality of sexual life of married women with PMS and their spouses " Quality of sexual life was measured at the beginning of the study (before the intervention), one and three months after the intervention, will be measured.
Method of measurement
In the study "Investigation of the effect of couple coping training on marital intimacy and the quality of sexual life of married women with PMS and their spouses",The quality of sexual life of women using an 18-question questionnaire on the quality of sexual life of Simond women And the quality of men's sexual life is measured by Abraham's 11-question questionnaire.

3

Description
couple coping
Timepoint
In the research "Investigation of the effect of couple coping training on marital intimacy and the quality of sexual life of married women with premenstrual syndrome and their husbands"Couple coping is measured at the beginning of the study (before the intervention), one and three months after the intervention.
Method of measurement
In the study "Investigation of the effect of couple coping training on marital intimacy and the quality of sexual life of married women with PMS and their husbands". Couple coping is measured by the 37-question Bodenmann questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training to strengthen couples' coping is a program to prevent marital problems that tries to strengthen marital abilities and skills. Counseling sessions will be conducted in the form of 8 sessions of 45 minutes of simultaneous counseling of couples and counselors, and counseling sessions will be held every two days. It will be offered on virtual platforms (as chosen by the participants).
Category
Lifestyle

2

Description
Control group: They will receive the usual training and care from the doctor and other members of the health team in comprehensive health centers, and at the end of the study, the training provided for the intervention group will be provided to them.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bolandian Health Center of Qazvin city
Full name of responsible person
Faizeh Safaralinejad
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin city
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 910 168 2019
Fax
+98 910 168 2019
Email
Faezeh.alinezhad1371@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mirhashmi
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin city
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Faizeh Safaralinejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Bahnar boulevard, Nasr, Qazvin city, Qazvin province
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 910 168 2019
Email
Faezeh.alinezhad1371@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Faizeh Safaralinejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Boulevard,Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 910 168 2019
Email
Faezeh.alinezhad1371@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Faizeh SafarAlinejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin Cit
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 910 168 2019
Email
Faezeh.alinezhad1371@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
It is only part of the sharing
When the data will become available and for how long
5 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
research works
From where data/document is obtainable
email
What processes are involved for a request to access data/document
send an email faezeh.alinezhad1371@gmail.com
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