Comparison survey the effectiveness of online counseling the Practical Application of Intimate Relationship Skills (PAIRS) versus the Training in marriage Enrichment (TIME) on marital intimacy.
Comparison effectiveness of online counseling the Practical Application of Intimate Relationship Skills (PAIRS) versus Training in marriage Enrichment (TIME) on marital intimacy
Design
This is an experimental study using the method of parallel clinical trial. Participants are women in their reproductive age who have mentioned the marital intimacy problems both in the initial interview and on the Bagarozzi questionnaire. participants are randomly assigned to one of the two intervention groups receiving two methods of online counseling: practical application of intimate relationship skills (PAIRS) and training in marriage enrichment (TIME). Women and their husbands complete the marital intimacy questionnaire at baseline, when the intervention is completed at week 8, and at follow-up of the study in week 12.
Settings and conduct
3 Comprehensive healthcare centers of Gerash. Sessions of intervention are conducted online one day in a week by the second author under the supervision of the supervisor and the consultant.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women of 15 - 49 who mentioned intimacy problems in the initial interview and on the Bagarozzi questionnaire; internet literacy; owning a smartphone; sexual relationship with their husbands; couple's consent; completing Marital Intimacy Questionnaire. Exclusion criteria: Pregnancy; acute psychological and personality disorders; substance abuse, tobacco use; systemic diseases.
Intervention groups
The intervention group A receives the online program of Practical Application of Intimate Relationship Skills (PAIRS) and the intervention group B receives the online program of Marriage Enrichment (TIME) in 8 sessions of 90 minutes each, one day in a week.
Main outcome variables
Change in the average scores of marital intimacy in women and their husbands, measured by the Bagarozzi Marital Intimacy Questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220217054048N1
Registration date:2022-04-29, 1401/02/09
Registration timing:prospective
Last update:2022-04-29, 1401/02/09
Update count:0
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Leila Shiravan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5245 1335
Email address
l.shiravan@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison survey the effectiveness of online counseling the Practical Application of Intimate Relationship Skills (PAIRS) versus the Training in marriage Enrichment (TIME) on marital intimacy.
Public title
Comparison of the effectiveness of Intimate Relationship skills versus the Training in marriage Enrichment on marital intimacy.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Married women between the ages of 15 and 49 who had mentioned marital intimacy problems both in the initial interview and on the Bagarozzi questionnaire.
Fluency in Persian language
Internet literacy and owning a smartphone
Having lived together for at least one year
Having a sexual relationship with husband
Being Interested in participating in training courses and attending the training sessions
Consent of both partners to participate in the study; completing the Marital Intimacy Questionnaire.
Exclusion criteria:
Pregnancy
women who have, or their husbands have, acute psychological and personality disorders, or a history of substance abuse and tobacco use
Having systemic diseases
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The specified sample size includes 88 people (women). The participants are randomized in two groups using the permuted block randomization method by the use of the software “Random Allocation” version 1, https://random-allocation-software.software.informer.com/1.0/. Considering the sample size (88 people) and also the similar size of blocks (due to having two intervention groups of A and B, the size of the block is 2 by the power of 4 which is 16) the software calculated the number of blocks to be 6.
Randomization is done in this way: women who have mentioned marital intimacy problems both in the initial interview and on the Bagarozzi questionnaire get a number from 1 to 88 according to the order of their attendance. Then, from among the 6 blocks, one block is chosen randomly which contains the name of the intervention group according to the patient’s code; therefore, each participant is randomly allocated to one of the intervention groups. After the completion of the first block, the second block is chosen randomly and the process of randomization continues. Also, since the randomization of participant in two intervention groups is carried out separately in each of the Comprehensive Healthcare Centers, two blocks are randomly allocated to each center and participants are divided into intervention group based on their numbers in the chosen blocks in each center.
Blinding is not possible since women are aware of the type of 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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
College of Nursing and Midwifery, Bo Ali Sina alley, Timsar Fallahi street, Safaieh neighborhood
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR.SSU.REC.1400.234
Health conditions studied
1
Description of health condition studied
Marital intimacy counseling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measuring the average scores of intimacy in women and their husbands
Timepoint
At baseline, the completion of intervention in week 8, and follow-up of the study in week 12.
Method of measurement
Bagarozzi Marital Intimacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group A receives the online program of the Practical Application of Intimate Relationship Skills (PAIRS) which includes these sessions: trust therapy, the importance of communication, personal history, bonding, clarification of mental imagery, clarification of expectations and days of love, adaptation to family functioning, summarizing and conclusion. Intervention is carried out in 8 sessions of 90 minutes each. The contents of online sessions in Skyroom are presented in the form of text, graphics, videos, clips, group chats and questions and answers. In every session, homework is presented and corrected via WhatsApp application by the second author under the supervision of the first and the third authors. Participants are provided with free weekly internet packages.
Category
Behavior
2
Description
The intervention group B receives the online program of Training in Marriage Enrichment (TIME) which include these sessions: responsibility, encouragement, preferences and values, effective communication skills, choices, conflict resolution, application of conflict resolution skills, and equal marital bonding. Intervention is carried out in 8 sessions of 90 minutes each. The contents of online sessions in Skyroom are presented in the form of text, graphics, videos, clips, group chats and questions and answers. In every session, homework is presented and corrected via WhatsApp application by the second author under the supervision of the first and the third authors. Participants are provided with free weekly internet packages.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib Comprehensive Healthcare Center
Full name of responsible person
Ali Reza Massah
Street address
Ali ibn Abi Talib Comprehensive Healthcare Center, Next to the Red Crescent road relief base, Shahid Saadat Boulevard
City
Gerash
Province
Fars
Postal code
74417-14487
Phone
+98 71 5245 1033
Email
info@gerums.ac.ir
2
Recruitment center
Name of recruitment center
Mohammad Rasool Allah Comprehensive Healthcare Center
Full name of responsible person
Ali Reza Massah
Street address
Mohammad Rasool Allah Comprehensive Healthcare Center, Darmangah Street
City
Gerash
Province
Fars
Postal code
74419-43379
Phone
+98 71 5244 2224
Email
info@gerums.ac.ir
3
Recruitment center
Name of recruitment center
Saadat Comprehensive Healthcare Center
Full name of responsible person
Ali Reza Massah
Street address
Fath Al-Mubin Operation Street, Shohada Blvd.
City
Gerash
Province
Fars
Postal code
74416-00000
Phone
+98 71 5245 6033
Email
info@gerums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Hoshang Mehrparvar
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences and Health Services Yazd, Shahid Dr. Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?