NCT05796180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 22, 2023

Last Update Submit

February 3, 2026

Conditions

Keywords

Sexual Health CounselingSexual Life QualityPostpartumPostpartum Sexual Life QualityBETTER Model

Outcome Measures

Primary Outcomes (3)

  • Postpartum Sexual Life Quality Scale

    The scale is still under development.

    8 week

  • Arizona Sexual Experiences Scale

    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

  • VAS satisfaction scale

    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

Study Arms (2)

Behavioral: sexual health counseling based on the BETTER model

EXPERIMENTAL

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.

Behavioral: Behavioral: sexual health counseling based on the BETTER model

Control group: Routine postpartum care

NO INTERVENTION

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.

Interventions

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.

Behavioral: sexual health counseling based on the BETTER model

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older,
  • Able to speak and understand Turkish,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim Etlik Hospital

Ankara, Keçiören, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BehaviorSexuality

Condition Hierarchy (Ancestors)

Sexual Behavior

Study Officials

  • Nurgül ŞİMAL YAVUZ, Lecturer

    Lokman Hekim University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 22, 2023

First Posted

April 3, 2023

Study Start

November 18, 2024

Primary Completion

February 23, 2025

Study Completion

May 23, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations