The Effect of Mental Toughness Interventions During Birth on the Pelvic Floor in the Postpartum Period | NCT07771647 | Trialant

CompletedInterventionalNot ApplicableUpdated Aug 20, 2026

The Effect of Mental Toughness Interventions During Birth on the Pelvic Floor in the Postpartum Period

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07771647
Lead Sponsor: Istanbul University - CerrahpasaOTHER
Overall Status: Completed
Study Type: Interventional
Phase: Not Applicable
Enrollment: 62Actual
Last Update Posted: Aug 20, 2026Actual
Start Date: Jan 15, 2026Actual
Primary Completion Date: Jun 15, 2026Actual
Completion Date: Jun 15, 2026Actual

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: The Effect of Mental Toughness Interventions During Birth on the Pelvic Floor in the Postpartum Period
Brief Summary: This randomized controlled study aimed to determine the effect of mental toughness interventions initiated during the third trimester of pregnancy and applied during childbirth on pelvic floor-related distress in the postpartum period. The mental toughness interventions consisted of breathing exercises, relaxation exercises, focusing/concentration, and imagery. Pregnant women were randomly assigned to an intervention group or a control group. Participants in the intervention group were taught the mental toughness interventions during the third trimester and received follow-up training sessions at 32-34 and 36-38 weeks of gestation. During labor, the interventions were applied at cervical dilations of 5-7 cm and 8-9 cm. The control group received routine care. Mind-body index was assessed using the HeartMath device in both groups during labor. Pelvic floor-related distress was assessed using the Pelvic Floor Distress Inventory-20 at baseline and at 6 weeks postpartum.

Conditions

The medical conditions and diseases this study investigates.

Pregnancy
Labor Delivery
Breath Exercise

Interventions

The treatments and procedures being evaluated in this study.

Mental Toughness

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Eligibility Criteria: Inclusion Criteria:

Being primiparous

Being in the third trimester of pregnancy

Having no communication barriers

Being a pregnant woman with an expectation of vaginal delivery

Exclusion Criteria:

Being multiparous

Having a diagnosis of high-risk pregnancy

Having a diagnosed pelvic floor dysfunction (Urinary Incontinence, Fecal Incontinence, or Pelvic Organ Prolapse)

Being under 18 years of age

Having a planned cesarean delivery

Study Discontinuation Criteria:

Voluntary withdrawal from the study by the participant

Emergency cesarean delivery decision

Impairment of mental functions during the intrapartum or postpartum period

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Ankara Bilkent Şehir Hastanesi

Ankara, Ankara 06800, Turkey (Türkiye)

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Istanbul University - CerrahpasaOTHER

Similar Studies

Other registered studies that closely resemble this one.

This randomized controlled study was conducted to evaluate the effect of mental toughness interventions initiated during the third trimester of pregnancy and continued during childbirth on pelvic floor-related distress in the postpartum period. The mental toughness intervention consisted of breathing exercises, relaxation exercises, focusing/concentration, and imagery techniques.

During the third trimester of pregnancy, participants were randomly assigned to an intervention group or a control group using Randomizer.org. Participants in the intervention group received training on the mental toughness interventions. Two face-to-face follow-up sessions were conducted at 32-34 and 36-38 weeks of gestation. During these sessions, participants' understanding and ability to perform the interventions were assessed, their questions were answered, and additional practice training was provided when necessary. Participants in the control group did not receive the mental toughness interventions and continued to receive routine care until childbirth.

During labor, the mental toughness interventions were applied to participants in the intervention group at cervical dilations of 5-7 cm and 8-9 cm, for a total of two applications. Following each intervention, the mind-body index was assessed using the HeartMath device to objectively evaluate the participants' mind-body state during labor. Participants in the control group received routine intrapartum care, and their mind-body index was assessed using the HeartMath device at the same cervical dilation stages of 5-7 cm and 8-9 cm.

The interventions were designed to promote relaxation and reduce mental and physical tension during labor. The study examined whether relaxation and improved mind-body regulation during childbirth could contribute to reducing the additional physical and muscular load on the pelvic floor and consequently affect pelvic floor-related outcomes in the postpartum period.

Following randomization, baseline assessments included the Descriptive Information Form and the Pelvic Floor Distress Inventory-20 (PFDI-20). Within 48 hours after childbirth, the Birth and Postpartum Information Form was administered to participants in both groups. At 6 weeks postpartum, the PFDI-20 was administered again to assess pelvic floor-related distress.