NCT07139704

Brief Summary

Aim: This study will aim to evaluate the effect of mindfulness-based sexual counseling on body appreciation, sexual distress, and sexual self-confidence in postpartum women with episiotomy. Method: This randomized controlled experimental study will include participants assigned to intervention and control groups. The intervention group will receive a four-week mindfulness-based sexual counseling program consisting of eight sessions, while the control group will receive routine care. Body Appreciation, Sexual Distress, and Sexual Self-Confidence scales will be administered as pre- and post-tests.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

August 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 17, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

Mindfulness-Based Sexual CounselingMİDWİFERYEpisiotomyPostpartum WomenBody Appreciation

Outcome Measures

Primary Outcomes (3)

  • Female Sexual Distress Inventory-Revised (FSSI-R):

    Developed by Derogatis et al. (2008) and adapted to Turkish by Aydın et al. (2016), it is a 13-item, five-point Likert-type scale assessing personal distress associated with sexual dysfunction. Possible scores range from 0 to 52, with higher scores indicating greater sexual distress. The cut-off point is ≥ 11.5. The Cronbach's alpha coefficient is 0.98.

    4 WEEEK

  • Sexual Self-Esteem Scale (SSS)

    Developed by Çelik (2012), it consists of 13 items. Items are scored from 1 ("never") to 4 ("always"). The total score ranges from 13 to 52, with higher scores indicating higher sexual self-confidence. The Cronbach's alpha coefficient is 0.88.

    4 WEEK

  • Body Esteem Scale (BSS)

    Developed by Cragun (2013) and adapted to Turkish by Arslan et al. (2020). It is a 15-item, five-point Likert-type scale consisting of three subscales: body esteem-weight, body esteem-appearance, and body esteem-quality. The subscale Cronbach's alpha coefficients are 0.940, 0.920, and 0.810, respectively.

    4 WEEK

Study Arms (2)

MBSR-BA

EXPERIMENTAL

This study will aim to evaluate the effect of mindfulness-based sexual counseling on body appreciation, sexual distress, and sexual self-confidence in postpartum women with episiotomy.This randomized controlled experimental study will include participants assigned to intervention and control groups. The intervention group will receive a four-week mindfulness-based sexual counseling program consisting of eight sessions, while the control group will receive routine care. Body Appreciation, Sexual Distress, and Sexual Self-Confidence scales will be administered as pre- and post-tests.

Behavioral: Mindfulness-Based Sexual Counseling (MBSR-BA)

control:

NO INTERVENTION

Routine Postpartum Care

Interventions

A MBSR-based sexual counseling program applied to women after episiotomy, 2 sessions per week for 4 weeks, 8 sessions in total.

MBSR-BA

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPOSTPORTUM WOMEN
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having had a vaginal birth and an episiotomy,
  • Having a follow-up appointment with the Family Health and Medical Center at 8 weeks postpartum,
  • Being able to read and write in Turkish,
  • Having a 3rd or 4th degree perineal tear

You may not qualify if:

  • History of pelvic surgery,
  • Significant psychiatric illness,
  • Presence of chronic illness that may affect sexual function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş, Kahramanmaraş, (542) 826-7629, Turkey (Türkiye)

Location

Central Study Contacts

HATİCE GÜL ÖZTAŞ, DİRECTOR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single (Care Provider)
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2025

First Posted

August 24, 2025

Study Start

September 20, 2025

Primary Completion

October 28, 2025

Study Completion

December 30, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations