Evaluation of the effect of intervention that promotes skill of sexual talk with spouse based on gamification on the level of sexual compatibility and satisfaction in couples: a randomized controlled trail
Determining the effect of gamification-based sexual conversation skill enhancement intervention on the level of compatibility and sexual satisfaction in couples who referred to a nursing home in the neighborhoods of Tehran province in 1401
Design
The clinical trial has a control group and two intervention groups, randomized by lottery, without blinding, on 41 couples in each group, with a total of 123 couples.
Settings and conduct
The names of women aged 18 to 45 years registered in the neighborhood centers in the intervention group 1، 2 and the control group.
Participants/Inclusion and exclusion criteria
Reproductive age (18-45 years), married for more than one year, having a spouse and active sex, having Iranian nationality, having the ability to read and write, having a dedicated smart cell phone, no history of couples participating in sexual skill training courses and counseling In the past 2 months, the husband's participation and accompaniment in educational programs, no alcohol and drug use in the couple, no sexual dysfunction , no disabilities, no known chronic diseases، Lack of chronic psychiatric disorders and problems (self-reported)
Intervention groups
The couples of the intervention group 1 will play the sexual conversation skill game online once a week for one month and twice a week. The researcher will answer the questions raised by the people. In intervention group 2, women share brochure content with their husbands. No training is given in the control group.
Main outcome variables
Sexual satisfaction and sexual compatibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220712055440N1
Registration date:2022-09-25, 1401/07/03
Registration timing:registered_while_recruiting
Last update:2022-09-25, 1401/07/03
Update count:1
Registration date
2022-09-25, 1401/07/03
Registrant information
Name
Maryam Nekoolaltak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
mnekoolaltak@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intervention that promotes skill of sexual talk with spouse based on gamification on the level of sexual compatibility and satisfaction in couples: a randomized controlled trail
Public title
the effect of intervention that promotes skill of sexual talk with spouse based on gamification on the level of sexual compatibility and satisfaction in couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Reproductive age (18-45 years)
Marriage duration more than one year
Having a spouse and active sex
Having Iranian nationality
Having the ability to read and write
Having a dedicated smart phone
Participation and companionship of the husband in educational programs
Exclusion criteria:
history of couples participating in sexual skill training and counseling courses in the last 6 months
sexual dysfunction (self-reported)
any disability (self-declaration)
suffering from known chronic diseases (self-reported)
chronic psychiatric disorders and problems (self-reported)
alcohol and drug use in couples
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
123
More than 1 sample in each individual
Number of samples in each individual:
1
The spouses of the research women are also present in this research
Randomization (investigator's opinion)
Randomized
Randomization description
Out of 23 neighborhood houses in the 6th district of Tehran Municipality, 3 neighborhood houses are selected by lottery from the most populated neighborhoods and the samples entered into the study in all 3 neighborhood houses are randomly placed in intervention groups 1, 2 and control.
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 Tehran Nursing and Midwifery and Rehabilitation Faculty
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-01-13, 1400/10/23
Ethics committee reference number
IR.TUMS.FNM.REC.1400.184
Health conditions studied
1
Description of health condition studied
Educational - advisory
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual satisfaction score in the Larson questionnaire
Timepoint
The amount of sexual satisfaction before the start of the intervention and 4 and 8
Method of measurement
Larson questionnaire
2
Description
Sexual compatibility score in the questionnaire of sexual compatibility with spouse (Dr. Nekulal Tek et al.)
Timepoint
The level of sexual compatibility before the start of the intervention and 4 and 8
Method of measurement
questionnaire of sexual compatibility with spouse (Dr. Nekulal Tek et al.)
Secondary outcomes
1
Description
Sexual conversation skills
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Sexual conversation questionnaire
Intervention groups
1
Description
Intervention group:Intervention group 1 will play the sexual conversation skill game with each other (couples) twice a week for one month, and once a week the researcher will answer the questions raised online through WhatsApp. Questionnaires are completed before and 4 and 8 weeks after the intervention by both intervention groups.
Category
Behavior
2
Description
Intervention group:Intervention group 2, women share the content of the brochure that contains sexual conversation skills with their husbands. And the questionnaires are completed before and 4 and 8 weeks after the intervention by both intervention groups
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarai neighborhood, district 6, Tehran
Full name of responsible person
Ali Karimi
Street address
No. 64، 2nd floor،Municipality Building،Nusrat St،Nusrat St
City
Tehran
Province
Tehran
Postal code
2
Phone
+98 21 6657 0192
Email
eli_nae@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotohi
Street address
School of Nursing and Midwifery.Mirkhani St. Tohid square.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
mnekoolaltak@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Nekoolaltak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery،Mirkhani St.،Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
mnekoolaltak@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Nekoolaltak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery،Mirkhani St.،Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
mnekoolaltak@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Nekoolaltak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery،Mirkhani St.،Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
mnekoolaltak@sina.tums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study data can be shared after de-identifying individuals
When the data will become available and for how long
six months after publication of finding
To whom data/document is available
The data of this research will be accessible to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data obtained from this study will be accessible only to conduct similar studies
What processes are involved for a request to access data/document
Initial correspondence via e-mail, face-to-face meeting and presentation of a work proposal similar to the current research, providing sufficient evidence for the similarity of your research with the current research, reading the proposal by the current research manager, making a decision and announcing the result by the current research manager, providing the researcher with access to data. Providing data files for on-site use.