NCT06632366

Brief Summary

Sexual function in the postpartum period, the gateway to newness and change, can be affected by problems such as caring for a new baby, breastfeeding, fatigue, anxiety about pain during sexual intercourse, postpartum depression, pelvic floor dysfunction, urinary symptoms and body image. Changes in sexual function are common in the postpartum period. Pregnancy and childbirth is a period in a woman's life that causes hormonal and physical changes and has an impact on the parents' quality of life. Postpartum sexual function is an important issue for couples, as the first sexual intercourse after childbirth is an important step for couples to establish intimate relationships. Many factors affect postpartum sexual dysfunction, including number of births, breastfeeding, mode of delivery, episiotomy, physical and psychological dysfunction, including fatigue and postpartum depression. Without adequate information and counseling on sexual life by health professionals in the postpartum period, most women may remain silent about their sexual concerns and anxieties, preferring instead to share their problems with friends. More holistic and multidisciplinary approaches are needed to treat female sexual dysfunctions. The use of mindfulness-based therapies has recently become widespread in the treatment of women diagnosed with sexual dysfunction.Thanks to mindfulness practices, it has been observed that women perceive stimuli better and are able to notice clues that they did not notice before. The Compassion Focused Therapy program is one of these practices. It is known to integrate well with existing approaches to therapy and offers some useful ways of reducing sexual problems to provide a coherent rationale for treatment strategies.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

February 5, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

April 26, 2024

Last Update Submit

October 7, 2024

Conditions

Keywords

postpartum, midwifery, sexuality

Outcome Measures

Primary Outcomes (1)

  • Arizona Sexual Experiences Scale- Female (ASES-F)

    The female form includes questions investigating sexual drive, psychological arousal, physiological arousal (vaginal lubrication), the capacity to reach orgasm and the feeling of satisfaction after orgasm. Each question in the scale is scored from 1 to 6, and the minimum score that can be obtained from the total score is 5 and the maximum is 30. A total score of 19 and above from the scale, a score of 5 or 6 for any item or a score of 4 for three or more items indicates the presence of sexual dysfunction. While low scores represent that the sexual response is effective, comfortable and satisfying, high scores indicate the presence of sexual dysfunction. The total internal consistency coefficient of the scale is 0.89 and the Cronbach alpha reliability coefficient is 0.90.

    ten weeks

Secondary Outcomes (1)

  • Sexual Quality of Life Scale- Female (SQOL-F)

    ten weeks

Other Outcomes (1)

  • The Revised Marital Adjustment Scale

    ten weeks

Study Arms (2)

Sexual Dysfunction in the Postpartum Period

EXPERIMENTAL

In the research, Awareness-Based Self-Compassion Training sessions will be held with the women in the experimental group twice a week for 3 weeks, six times in total.Women in the postpartum period included in the control group will be interviewed twice in total. In the first interview, the "Personal Information Form", "Sexual Life Quality Scale-Female" and "Male Compatibility Scale" will be applied and pre-test data will be obtained. Eight weeks after the pre-test data is obtained, post-test data will be obtained by applying the "Arizona Sexual Experiences Scale-Female", "Sexual Quality of Life Scale-Female" and "Dutch Compatibility Scale".

Other: Sexual Dysfunction in the Postpartum Period

control

NO INTERVENTION

Women in the postpartum period included in the control group will be interviewed twice in total. In the first interview, the "Personal Information Form", "Sexual Life Quality Scale-Female" and "Male Compatibility Scale" will be applied and pre-test data will be obtained. Eight weeks after the pre-test data is obtained, post-test data will be obtained by applying the "Arizona Sexual Experiences Scale-Female", "Sexual Quality of Life Scale-Female" and "Dutch Compatibility Scale".

Interventions

The experimental group will receive mindfulness-based self-compassion training. The control group will not receive any intervention.

Sexual Dysfunction in the Postpartum Period

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostpartum women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Erbal communicator and no literacy disability,
  • Living with his wife,
  • Beginning postpartum sexual intercourse, menstrual cycle has not started
  • Between 2-6 months postpartum,
  • Having a healthy baby
  • Menstrual cycle has not started
  • Women diagnosed with sexual dysfunction (total score ≥19) according to the Arizona
  • Sexual Experiences Scale will be included in the study.

You may not qualify if:

  • Having undergone gynecological surgery during the study,
  • Have been or are currently diagnosed with a psychiatric illness,
  • Having attended any awareness-based training at least 6 months ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Provincial Directorate of Health

Gaziantep, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Bolsoy N, Sen S, Sezer G, Cakil M. The effect of training on women with postpartum sexual dysfunction: A randomized controlled trial. Niger J Clin Pract. 2023 Jul;26(7):949-956. doi: 10.4103/njcp.njcp_656_22.

    PMID: 37635579BACKGROUND
  • De Souza A, Dwyer PL, Charity M, Thomas E, Ferreira CH, Schierlitz L. The effects of mode delivery on postpartum sexual function: a prospective study. BJOG. 2015 Sep;122(10):1410-8. doi: 10.1111/1471-0528.13331. Epub 2015 Mar 6.

    PMID: 25752211BACKGROUND
  • Bhat GS, Shastry A. Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study. J Sex Med. 2022 Nov;19(11):1634-1643. doi: 10.1016/j.jsxm.2022.08.189. Epub 2022 Sep 25.

    PMID: 36167664BACKGROUND
  • Kolberg Tennfjord M, Hilde G, Staer-Jensen J, Siafarikas F, Engh ME, Bo K. Effect of postpartum pelvic floor muscle training on vaginal symptoms and sexual dysfunction-secondary analysis of a randomised trial. BJOG. 2016 Mar;123(4):634-42. doi: 10.1111/1471-0528.13823. Epub 2015 Dec 22.

    PMID: 26691895BACKGROUND

MeSH Terms

Conditions

Sexuality

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Hacer Ünver Koca, PhD

    İnönü University

    STUDY DIRECTOR

Central Study Contacts

Fadime Biçer Şahin, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research was designed as a randomized controlled experimental type.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 26, 2024

First Posted

October 9, 2024

Study Start

February 5, 2024

Primary Completion

February 1, 2025

Study Completion

June 30, 2025

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations