Effectiveness comparison of online relationship enhancement couple therapy program versus systematic desensitization on sexual relationship anxiety in women undergoing infertility treatment with timed intercourse
Effectiveness comparison of online relationship enhancement couple therapy versus systematic desensitization on sexual relationship anxiety in infertility
Design
This study is a quasi-experimental study with a parallel clinical trial that has two groups of 34 people, relationship enhancement couple therapy program and systematic desensitization. In order to prevent the decline in the quality of online education, Each group of 34 people is divided into 2 groups of 17 people. 68 women who have sexual anxiety according to the questionnaire are given a number from 1 to 68. Using random allocation1 software, individuals are randomly assigned to two groups of relationship therapy and regular desensitization based on the software output table.
Settings and conduct
Shahrekord infertility treatment Invitation to study, sample selection, random assignment, and psychological intervention is done by the second author under the supervision of a supervisor and a couple therapy counselor.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian nationality; Persian fluency; primary infertility; having sexual anxiety based on the Sexual Anxiety Scale; Internet literacy and smartphone; having shared bed with husband. Exclusion criteria: Pregnancy; having neurological diseases and taking psychiatric drugs; not having internet; Dispute in recent month; psycho counseling during last 6 months; unpleasant events like relevant death.
Intervention groups
Group 1 receives online relationship enhancement couple therapy program and group 2 receives online systematic desensitization in 8 sessions of 60 minutes. The content of the sessions in Skyroom is presented in groups. The counselor, the counseling method and the counseling time are the same for both groups.
Main outcome variables
Change in the mean scores of sexual anxiety measured by the questionnaire "Measurement of sexual anxiety" .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211127053188N1
Registration date:2021-12-25, 1400/10/04
Registration timing:prospective
Last update:2021-12-25, 1400/10/04
Update count:0
Registration date
2021-12-25, 1400/10/04
Registrant information
Name
Maryam Afzal dehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0444
Email address
afzal-m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness comparison of online relationship enhancement couple therapy program versus systematic desensitization on sexual relationship anxiety in women undergoing infertility treatment with timed intercourse
Public title
Effectiveness comparison of relationship enhancement couple therapy versus systematic desensitization on sexual anxiety in infertility
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a primary infertility record in Hazrat Zahra Infertility Center in Shahrekord
Having sexual anxiety based on a sexual anxiety test questionnaire
Internet literacy and smartphone
Having a bed with his wife
Willingness to participate in this study
Iranian nationality
Fluency in Persian
Exclusion criteria:
Pregnancy
Ovarian Hyperstimulation Syndrome (OHSS)
Having neurological diseases and taking psychiatric drugs based on infertility records
Tragic events such as the death of loved ones in the last two months
Family quarrel in a recent month
Living in a place without internet access
Participate in psychological counseling sessions or similar studies over the past 6 months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 68 women under treatment with sexual anxiety are randomly assigned a number from 1 to 68. Using random allocation1 software, individuals are randomly assigned to two groups of Relationship Improvement Couple Therapy (RECT) and Regular Desensitization (SD) based on the software output table. Each group of 34 people is then randomly divided into two subgroups of 17 people. Blindness is not possible due to women's awareness 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
Street address
4th floor, corner of the alley, No. 40, Alley 16, varzesh Street, shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815846679
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.SSU.REC.1400.160
Health conditions studied
1
Description of health condition studied
Sexual anxiety counseling
ICD-10 code
Z70
ICD-10 code description
Counselling related to sexual attitude, behaviour and orientation
Primary outcomes
1
Description
Measuring the mean scores of sexual anxiety in women undergoing infertility treatment
Timepoint
At baseline, when the intervention was completed at week 8 and at follow-up at study week 12 at the two groups
Method of measurement
Sexual Anxiety Scale (Davis et al.)
Secondary outcomes
1
Description
Spouse satisfaction score of counseling method in two groups
Timepoint
At the end of the intervention at week 8 and at the end of the study at week 12
Method of measurement
Satisfaction visual Scale with one question, score between 1-10
2
Description
Pregnancy frequency
Timepoint
Fallow up week 12
Method of measurement
Pregnancy diagnosis test
Intervention groups
1
Description
Intervention group 1 receives an online relationship enhancement couple therapy program. Intervention sessions include 8 sessions of 60 minutes. The content of online sessions in the form of text, graphics, videos, clips, group chat and questions and answers in Skyroom is presented in groups. Homework and its evaluation by the second author is done under the supervision of the first and third authors in all sessions through WhatsApp. In case of absence of women up to two sessions, a summary of the content of these two sessions will be provided to absentees. Free weekly internet package is provided to women.
Category
Behavior
2
Description
Intervention group 2 receives an online systematic desensitization program. Intervention sessions include 8 sessions of 60 minutes. The content of online sessions in the form of text, graphics, videos, clips, group chat and questions and answers in Skyroom is presented in groups. Homework and its evaluation by the second author is done under the supervision of the first and third authors in all sessions through WhatsApp. In case of absence of women up to two sessions, a summary of the content of these two sessions will be provided to absentees. Free weekly internet package is provided to women.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility treatment center of Hazrat Zahra Shahrekord
Full name of responsible person
Maryam Afzal Dehkordi
Street address
4th floor, No. 40, Alley 16, varzash Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815846679
Phone
+98 38 3333 0444
Email
afzal.midwife@gmail.com
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
۸۹۱۶۹۷۸۴۷۷
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?