Sexual Health Counseling Based on the BETTER Model

Sponsor

Lokman Hekim Üniversitesi (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05796180

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators wanted to examine the effect of sexual health counseling to women in the postpartum period on the quality of life of the participants.

Condition or Disease	Intervention/Treatment	Phase
Health Knowledge, Attitudes, Practice Sexuality	Behavioral: Behavioral: sexual health counseling based on the BETTER model	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Sexual Health Counseling Based on the BETTER Model on Postpartum Sexual Life Quality: A Randomized Controlled Study

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 4 weeks after the online meetings are over.	Behavioral: Behavioral: 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 4 weeks after the online meetings are over.
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.

Arm

Intervention/Treatment

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 4 weeks after the online meetings are over.

Behavioral: Behavioral: 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 4 weeks after the online meetings are over.

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.

Outcome Measures

Primary Outcome Measures

Postpartum Sexual Life Quality [8 week]
The scale is still under development.
Arizona Sexual Experiences Scale [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.
Female Sexual Satisfaction Scale [8 week]
The scale has 24 sub-dimensions of satisfaction, communication, agreeableness, personal concern and relational concern and consists of 30 items. In 29 items, a 5-point Likert scale ranging from "strongly disagree" to "strongly agree" is used. For one item, a 5-point Likert scale ranging from "totally satisfactory" to "not at all satisfactory" is used. Average scores are calculated for each subscale. Higher scores are interpreted as more sexual satisfaction. For each sub-dimension in the scale, the lowest score is 6.0 and the highest score is 30.0. Total Score = Satisfaction + Communication + Compliance + (Relational Worry + Personal Worry) /2 formula is used to calculate the total score of the scale. Accordingly, the lowest score that can be obtained from the scale is 24.0, and the highest score is 120.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Primiparous,
Have had a vaginal birth,
Without a diagnosed chronic disease (DM, HT, Heart disease, etc.),
18 years or older,
Able to speak and understand Turkish,

Exclusion Criteria:

• Edinburgh Postpartum Depression Scale score of 12 and above,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lokman Hekim Etlik Hospital	Ankara	Keçiören	Turkey

Sponsors and Collaborators

Lokman Hekim Üniversitesi

Investigators

Study Director: Nurgül ŞİMAL YAVUZ, Lecturer, Lokman Hekim Üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nurgül ŞİMAL YAVUZ, Lecturer, Lokman Hekim Üniversitesi

ClinicalTrials.gov Identifier:

NCT05796180

Other Study ID Numbers:

NSIMALYAVUZ

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nurgül ŞİMAL YAVUZ, Lecturer, Lokman Hekim Üniversitesi

Sexual Health Counseling

Sexual Life Quality

Postpartum

Postpartum Sexual Life Quality

BETTER Model

Study Results

No Results Posted as of Apr 3, 2023