NCT05954130

Brief Summary

Pregnancy is an important process with many changes in a woman's life. During this period, the sexual lives of couples may be affected due to anatomical, physiological and psychological changes. While sexual intercourse during pregnancy strengthens the harmony between spouses, emotional bond, and self-confidence of the woman, its role is important in terms of the continuation of the marriage. The development of technology in the world and in our country has led to an increase in the use of mobile devices. The emergence of telehealth and mobile applications with the Covid-19 pandemic has enabled individuals to access information whenever they want and more easily. The aim of this study was to determine the effect of mobile application support given to pregnant women for sexual health on sexual function and quality of sexual life. It is planned to develop a mobile application in this direction by preparing a guide, with the foresight that sexuality during pregnancy is not an easily expressed subject and that pregnant women and health workers need training materials. After the power analysis, it is aimed to reach a total of 70 people, 35 in the experimental group and 35 in the control group. Data will be collected with Personal Information Form, Female Sexual Function Index, Sexual Life Quality Scale and Qualitative Interview Form. Based on the developed guide and mobile application, training will be given to pregnant women in the first, second and third trimesters, and it is thought that the mobile application support specific to sexual health during pregnancy may contribute to increasing sexual function and sexual life quality.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

June 6, 2023

Last Update Submit

February 13, 2025

Conditions

Keywords

pregnancy, sexual life, education

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Function Index

    It was developed as a 19-item multidimensional scale to evaluate female sexual function. The scale assesses sexual problems or function in the last 4 weeks. In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0, and the lowest raw score is 4.0.

    Change in sexual functions during pregnancy at 9 months

Secondary Outcomes (1)

  • Sexual Quality of Life Scale

    Change in the quality of sexual life in 9 months of pregnancy

Study Arms (2)

Mobile Application Support Specific to Sexual Health in Pregnancy

EXPERIMENTAL

The training module will consist of 3 sessions. The first session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. The second and third sessions will last 1 hour, with 45 minutes of interactive narration and 15 minutes of qualitative interviews. Module sessions will have a dynamic structure that takes into account the needs of the pregnant woman in her trimester. The content of the training sessions will be structured on the following topics.

Other: Education

control

NO INTERVENTION

No training will be given to the pregnant women in the control group who accepted to participate in the study.

Interventions

Sexual Health in Pregnancy

Mobile Application Support Specific to Sexual Health in Pregnancy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswill be applied to pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In the first 3 months of pregnancy
  • Speaks and understands Turkish
  • Being able to read and write
  • Not having received prior education about sexuality during pregnancy

You may not qualify if:

  • Having a risky pregnancy (under 18 years of age, having a chronic and psychiatric disease, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Şule GÖKYILDIZ SÜRÜCÜ, Prof.

    gokyildizsule@gmail.com

    STUDY DIRECTOR
  • Emel SALCAN, Msc.Midwife

    emelers@hotmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: experimental and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 20, 2023

Study Start

September 9, 2024

Primary Completion

June 30, 2025

Study Completion

August 31, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations