- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796180
Sexual Health Counseling Based on the BETTER Model
The Effect of Sexual Health Counseling Based on the BETTER Model on Postpartum Sexual Life Quality: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Keçiören
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Ankara, Keçiören, Turkey (Türkiye)
- Lokman Hekim Etlik Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primiparous,
- Weeks of gestation 37 weeks and over,
- Who had a singleton pregnancy,
- Having a sexual partner/partner,
- Having started sexual intercourse before starting training,
- Without a diagnosed chronic disease (DM, HT, Heart disease, etc.),
- Labour week 37 weeks and over
- 18 years or older,
- Able to speak and understand Turkish,
Exclusion Criteria:
- Edinburgh Postpartum Depression Scale score of 12 and above,
- To have received training on sexual health and family planning in a hospital or other health institution other than discharge training,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group: Routine postpartum care
Routine postpartum care Women who gave birth vaginally and applied to the hospital for postpartum controls 8-10 weeks after delivery will be interviewed face-to-face with the women and the content of the research will be mentioned. Pre-evaluation forms will be applied to the women who accepted to participate in the study to evaluate the inclusion criteria. Women who meet the inclusion criteria will be divided into experimental-control groups using the block randomization method. Women in the control group will receive routine postpartum care administered in the hospital. Women in the control group will receive routine postpartum care administered in the hospital. Post-tests will be administered 8 weeks after the first interview. |
|
|
Experimental: Behavioral: sexual health counseling based on the BETTER model
Sexual health counseling based on the BETTER model The content of the research will be discussed by face-to-face interviews with women who gave birth vaginally and applied to the hospital for birth control 8-10 weeks after delivery. Pre-evaluation forms will be applied to women who have agreed to participate in the study to evaluate the inclusion criteria. Women who meet the inclusion criteria will be divided into experimental-control groups using the block randomization method. An appointment will be made for interviews with the women in the experimental group. It is planned that these meetings will be held in the form of online video calls and will last an average of 45 minutes. The final tests will be held 8 weeks after the online meetings are over. |
The content of the research will be discussed by face-to-face interviews with women who gave birth vaginally and applied to the hospital for birth control 8-10 weeks after delivery. Pre-evaluation forms will be applied to women who have agreed to participate in the study to evaluate the inclusion criteria. Women who meet the inclusion criteria will be divided into experimental-control groups using the block randomization method. An appointment will be made for interviews with the women in the experimental group. It is planned that these meetings will be held in the form of online video calls and will last an average of 45 minutes. The final tests will be held 8 weeks after the online meetings are over. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arizona Sexual Experiences Scale
Time Frame: 8 week
|
The Arizona Sexual Experiences Scale (ASEX) is a 6-point Likert-type self-report scale and consists of 5 questions.
This form reveals the capacity to reach orgasm, the feeling of satisfaction, vaginal wetness, arousal and sexual drive.
Each question is scored from 1 to 6.
The total score ranges from 5 to 30.
Low scores indicate that the sexual response is satisfactory, strong and easy, while high scores indicate the presence of sexual dysfunction.
The total scale score is formed by the sum of the scores of the scale items in the scale.
The cut-off point of the scale was determined as 11.
A score of 5 or more for each item indicates that there is a sexual dysfunction related to that item.
|
8 week
|
|
Postpartum Sexual Life Quality Scale
Time Frame: 8 week
|
The scale is still under development.
|
8 week
|
|
VAS satisfaction scale
Time Frame: 8 week
|
Women's satisfaction with sexual life will be evaluated with the visual analog scale (VAS).
It shows that women who score high on the scale, which is scored between 0 (very dissatisfied) and 10 (very satisfied), also have high sexual satisfaction.
|
8 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nurgül ŞİMAL YAVUZ, Lecturer, Lokman Hekim University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSIMALYAVUZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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