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Postpartum WomenMindfulness-BaNCT07139704

The Effect of Mindfulness-Based Sexual Counseling on Body Appreciation, Sexual Distress, and Sexual Self-Confidence in Postpartum Women With Episiotomy

A study testing Mindfulness-Based Sexual Counseling (MBSR-BA) in people with Postpartum Women, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Women
What is being tested?
Mindfulness-Based Sexual Counseling (MBSR-BA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Sep 2025to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

HATİCE GÜL ÖZTAŞ, DİRECTOR contact

05428267629

h.gul_akbaba@hotmail.com.tr

Turkey (Türkiye)1 site
  • Kahramanmaraş Sütçü İmama Universty

    Kahramanmaraş, Kahramanmaraş, (542) 826-7629

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

An episiotomy is a surgical incision made in the perineal muscles during labor to widen the vaginal opening, facilitate the safe and rapid delivery of the fetal head, shorten the second stage, reduce the risk of lacerations, and prevent anal sphincter damage (Carroli \& Mignini, 2009; Shmueli et al., 2017; Goh, Goh, \& Ellepola, 2018; Deyaso et al., 2022). This intervention, normally recommended only for medical indications, has become routine in many countries over time. This has led international health authorities such as the World Health Organization (WHO), the American College of Obstetricians and Gynecologists (ACOG), and NICE to issue clear warnings against unnecessary episiotomy (WHO, 2018; ACOG, 2006; NICE, 2023; Ghulmiyyah et al., 2022). According to the WHO's 2018 guidelines, episiotomy rates vary widely between countries. In Southeast Asia, this rate reaches 63%, while in Europe the average is 20-25%. In Turkey, the overall rate is reported as 52%, 93.3% in primiparous women, and 30.2% in multiparous women. Similarly high rates are reported in developing countries such as India (63.4%), Oman (66%), Cambodia (94.5%), and Taiwan (100%) (Djusad et al., 2024). Episiotomy can affect women's health not only during labor but also in the postpartum period. Research shows that this intervention is associated with complications such as postpartum perineal pain, dyspareunia, decreased sexual desire, and orgasmic disorders (Dedavid da Rocha \& Zamberlan, 2018; Khajehei et al., 2015; Buhling et al., 2018). Furthermore, episiotomy can cause sexual dysfunction, distorted body image, decreased sexual self-confidence, and lowered self-esteem (Khajehei et al., 2015; Buhling et al., 2018; Ghulmiyyah et al., 2022). Female sexual dysfunction is a condition characterized by lack of sexual desire, difficulty with arousal, orgasmic problems, and pain, which negatively affects an individual's quality of sexual life and psychological well-being. Its prevalence in the first 2-3 months after birth varies between 41-83% (De Souza et al., 2015). These disorders threaten psychological health by causing negative changes in body image and self-esteem (Ören \& Yaşar, 2023; Naisri, 2015).

Mindfulness is a mind-body practice that allows individuals to focus on the present moment and observe thoughts, emotions, and bodily sensations without judgment (Durna et al., 2019). Regular practice increases levels of happiness, psychological flexibility, compassion, and self-compassion, and reduces levels of depression, anxiety, and stress (İnci \& Ergen, 2019; Cengizhan \& Uçar, 2023). The literature reports that mindfulness-based interventions have positive effects on sexual dysfunction, body image, and self-esteem. However, studies examining the effects of mindfulness-based sexual counseling on sexual distress, body image, and sexual self-confidence in postpartum women who have undergone an episiotomy are extremely limited. In societies where sexuality is considered taboo, such as those in southeastern Turkey, such an intervention is anticipated to provide benefits at both the individual and societal levels. This study aims to evaluate the effects of mindfulness-based sexual counseling on body image, sexual distress, and sexual self-confidence in postpartum women experiencing episiotomy. The study is expected to fill a gap in the literature and offer a holistic, evidence-based, and culturally sensitive intervention model for postpartum sexual health.

Being tested
Mindfulness-Based Sexual Counseling (MBSR-BA)
Keywords
Mindfulness-Based Sexual Counseling, MİDWİFERY, Episiotomy, Postpartum Women, Body Appreciation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Sexual Counseling (MBSR-BA)Behavioural

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

Study groups in NCT07139704
Study groupRoleWhat they receive
MBSR-BAExperimentalThis 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.
Receives: Behavioral: Mindfulness-Based Sexual Counseling (MBSR-BA)
control:No interventionRoutine Postpartum Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 WEEEK

  2. 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.

    Measured: 4 WEEK

  3. 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.

    Measured: 4 WEEK

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2025
  2. Study start20 Sep 2025 (estimated)
  3. Primary completion28 Oct 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07139704
Sponsor's protocol ID
KahramanmaraşSIUIE7
Acronym
Mindfulness-Ba
Status last verified
Aug 2025
First submitted
17 Aug 2025
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Sexual Counseling (MBSR-BA) in people with Postpartum Women, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact HATİCE GÜL ÖZTAŞ, DİRECTOR (05428267629, h.gul_akbaba@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Female Sexual Distress Inventory-Revised (FSSI-R): (time frame: 4 WEEEK). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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