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).
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmama Universty
Kahramanmaraş, Kahramanmaraş, (542) 826-7629
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.
- Conditions
- Postpartum Women
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Sexual Counseling (MBSR-BA) |
| control: | No intervention | Routine Postpartum Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted24 Aug 2025
- Study start20 Sep 2025 (estimated)
- Primary completion28 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Sexual Counseling on Body Appreciation, Sexual Distress, and Sexual Self-Confidence in Postpartum Women With Episiotomy
- ClinicalTrials.gov ID
- NCT07139704
- Acronym / sponsor ID
- Mindfulness-Ba / KahramanmaraşSIUIE7
- Conditions
- Postpartum Women
- Keywords
- Mindfulness-Based Sexual Counseling, MİDWİFERY, Episiotomy, Postpartum Women, Body Appreciation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 28 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR-BA | Experimental | Behavioral: Mindfulness-Based Sexual Counseling (MBSR-BA)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. |
| control: | No intervention | –Routine Postpartum Care |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having had a vaginal birth and an episiotomy,
Key exclusion criteria (3 listed)
- • History of pelvic surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Sexual Counseling (MBSR-BA)A MBSR-based sexual counseling program applied to women after episiotomy, 2 sessions per week for 4 weeks, 8 sessions in total. | Behavioural | MBSR-BA |
Primary outcome
Female Sexual Distress Inventory-Revised (FSSI-R):
Time frame: 4 WEEEK
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.
Sexual Self-Esteem Scale (SSS)
Time frame: 4 WEEK
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.
Body Esteem Scale (BSS)
Time frame: 4 WEEK
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.