The effect of online counseling based on mindfulness approach on sexual intimacy of diabetic women
Design
A clinical trial with a control group, with parallel groups, not blinded, randomized randomized block allocation on 60 patients (women) is done by visiting http://www.randomization.com.
Settings and conduct
The research site is Yazd Diabetes Center. The sample size is 60 people who are randomly assigned, 30 people in the experimental group and 30 people in the control group and the intervention in the form of 8 counseling sessions for one and a half hours and online with the approach Mindfulness is done in WhatsApp space and the control group will receive 4 training sessions through an educational pamphlet. (Active control group) The measured instrument is a demographic information questionnaire and a sexual intimacy questionnaire that is evaluated as pre-test and post-test, before the intervention, immediately after the intervention and one month after the intervention in the experimental group and compared with the control group. will be.
Participants/Inclusion and exclusion criteria
clusion criteria include:
• Women of reproductive age 18 to 49 years
•Having type 2 diabetes
•Have at least one year of living together.
Inclusion criteria:
• You and your spouse are addicted to drugs according to the patient
• Consumption of psychiatric drugs by oneself and one's spouse according to the patient
• Participate in simultaneous psychological and psychiatric interventions
Intervention groups
The intervention is done in the form of 8 sessions of counseling for one and a half hours and online with WhatsApp mindfulness approach on sexual intimacy of women with type 2 diabetes, and the control group will receive 4 sessions of online training through an educational pamphlet.
Main outcome variables
Increased sexual intimacy in women with type 2 diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211222053483N1
Registration date:2022-06-21, 1401/03/31
Registration timing:prospective
Last update:2022-06-21, 1401/03/31
Update count:0
Registration date
2022-06-21, 1401/03/31
Registrant information
Name
Fereshteh Heshmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 0148
Email address
f.heshmati@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online counseling based on mindfulness approach on sexual intimacy of diabetic women
Public title
The effect of online counseling based on mindfulness approach on sexual intimacy of diabetic women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age 18 to 49 years
Having type 2 diabetes
The person's blood sugar is controlled.
Have at least one year of living together.
Have access to smart phones and the Internet.
Willingness to participate in virtual meetings.
Fill out a voluntary and informed written consent form online.
Exclusion criteria:
His and his wife's drug addiction, according to the patient
Consumption of psychiatric drugs by himself and his wife, according to the patient
Participate in simultaneous psychological and psychiatric interventions
Pregnancy
Systemic diseases or disease exacerbations
Having erectile dysfunction in the spouse
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation method:
The specified sample size includes 60 people (women), each person can be assigned a number between 1 and 60, which is done by referring to the online site random allocation. Assignment Model Due to the fact that this study is in two groups (experimental and control group), the first generation randomization model is used that each sample (female) is placed in a treatment group called block randomization and Http://www.randomization.com The software randomly assigns each person to one of the two groups A and B, which means that the allocation of people to each of the two groups in the order AB occurs. It does not fall but is done in the order in which the software output is placed.
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
Research Ethics Committees of Shahid Sadoughi University of Medical Sciences
The effect of online counseling based on mindfulness approach on sexual intimacy of diabetic women
Timepoint
The sexual intimacy of the subjects will be assessed before the intervention, immediately after the intervention and one month after the intervention.
Method of measurement
Invalid sexual intimacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is done in the form of 8 counseling sessions for one and a half hours and online with a mindfulness approach in the WhatsApp space.
Category
Behavior
2
Description
Control group: Sexual health trainings such as male and female device anatomy, sensory points and sexual response cycle, etc. are received as an educational pamphlet in 4 sessions in WhatsApp and online (active control group) and after the intervention if Willingness to be consulted.
What processes are involved for a request to access data/document
Applicant request by phone or e-mail, explanation of how to conduct their research, coordination with the Vice Chancellor for Research of Yazd University of Medical Sciences and obtaining permission from them, providing the requested information and data to the applicant.