Determining the effect of counseling approach based on Internet-Based Cognitive Behavior Therapy on sexual intimacy in woman whose husbands have spinal cord lesion
Design
Clinical trials with community based and pragmatic control group, with parallel groups, Not blinded, randomized
Settings and conduct
After obtaining the necessary permits from the Vice Chancellor for Research and Technology and the University Ethics Committee, eligible women are invited to refer to the Yazd Spinal Cord Injury Association. After considering the inclusion and exclusion criteria, 60 people were targeted and based on the table of random numbers, people were divided into two equal groups of intervention and control. After obtaining informed consent, a sexual intimacy questionnaire and a demographic information questionnaire were completed by the subjects. Including 8 sessions of 90-minute weekly counseling after the classes and a month later the questionnaires were completed again and the results were analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
inclusion criteria: The desire to participate in the study, being Iranian, age 18-45, having literacy and reading skills, married and having a spouse, the only person to be a spouse.
exclusion criteria: alcohol and drug addiction, use of drugs affecting sexual function, diseases affecting sexual function, psychiatric disorders and pregnancy.
Intervention groups
Intervention group: 18- to 45-year-old women with spinal cord injury spouse who have low sexual intimacy. The intervention is performed in 8 sessions of 90 minutes for cognitive-behavioral therapy. Control group: 18- to 45-year-old women with spinal cord injury spouse who Receive general sexual health information in the form of pamphlets. (Active control)
Main outcome variables
Sexual intimacy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220227054139N1
Registration date:2022-06-30, 1401/04/09
Registration timing:registered_while_recruiting
Last update:2022-06-30, 1401/04/09
Update count:0
Registration date
2022-06-30, 1401/04/09
Registrant information
Name
Maryam Malboubi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
m.malboubi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-23, 1401/03/02
Expected recruitment end date
2022-08-24, 1401/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Internet-Based Cognitive Behavior Therapy on sexual intimacy in woman whose husbands have spinal cord lesion
Public title
The effect of Internet-Based Cognitive Behavior Therapy on sexual intimacy in woman whose husbands have spinal cord lesion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 18-45 and their husbands have a spinal cord injury
Be the only wife of the man
Have at least one year of living together
Live in a house during the research period and do not intend to divorce
Have access to smart phone and internet
Be willing to participate in virtual meetings
Fill out a voluntary and informed online written consent form
Exclusion criteria:
The addiction of himself and his wife to drugs, according to the patient
The use of psychiatric drugs by oneself and one's spouse according to the patient
Pregnancy
Participate in simultaneous psychological and psychiatric interventions
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:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Sciences
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Thaisar Fallahi Avenue، Safaiyeh،Yazd
City
Yazd
Province
Yazd
Postal code
03538241757
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.SSU.REC.1400.193
Health conditions studied
1
Description of health condition studied
Sexual intimacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual intimacy score in the invalidity questionnaire
Timepoint
Measurement of sexual intimacy score before and after the intervention and one month after the intervention
Method of measurement
Sexual Intimacy Questionnaire (Persian text) based on Bagarozi Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women 18-45 years old with a spinal cord injury spouse who has low sexual intimacy. The intervention is performed in 8 sessions of 90 minutes based on cognitive behavioral therapy.
Category
Behavior
2
Description
Control group: 18- to 45-year-old women with spinal cord injury who have low sexual intimacy and receive general sexual health information in the form of a pamphlet. (Active control)