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CompletedNCT07771647Updated Aug 20, 2026

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

An interventional study of Mental Toughness in Pregnancy, Labor Delivery and Breath Exercise, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 30 studies in Pelvic Floor Disorders with a site in Turkey — 5 open to participants now, 6 under way, 1 of them phase 3. Pelvic Floor Disorders · Turkey.

Enrollment
6th of 21
62 · median 40
Started
2026
with 1 other
No phase
20 of 30
3 open now
Registered
21st of 30
by date
Lead sponsor
2 of 30
Istanbul University - Cerrahpasa

Among the 30 studies in Pelvic Floor Disorders with a site in Turkey, this one is the 6th largest by enrollment of the 21 interventional ones that give a count, is one of 2 that started in 2026, is one of 20 with no phase, and was the 21st registered.

Pelvic Floor Disorders

212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.

Browse Pelvic Floor Disorders studies →

Open to participants now

5 of the 30 studies in Pelvic Floor Disorders with a site in Turkey are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 27 Pelvic Floor Disorders studies recruiting now, 17 (63%) set no upper age limit and 10 (37%) stop at 75 or younger; none take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Pregnancy
  • Labor Delivery
  • Breath Exercise
  • Relaxation
  • Focus Health Pregancy Women
  • Imagery, Psychotherapy
  • Pelvic Floor Disorder
  • Pelvic Floor Muscle Activation

Keywords

  • Mental Toughness
  • Labor
  • Pelvic Floor
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Mental Toughness Intervenıons

    The group that will apply the mental resilience interventions taught during the last trimester of pregnancy (breathing exercises, relaxation techniques, focusing/concentration practices, and imagery) during the childbirth process."

    Behavioral: Mental Toughness

  • No intervention
    Control Group

    Routine care will be given

Interventions

  • BehavioralMental Toughness

    breathing exercises, relaxation techniques, focusing/concentration practices, and imagery

06

What researchers measure

Primary outcomes

  1. Pelvic Floor Distress Inventory- 20

    Assesses the presence and severity of pelvic floor distress symptoms, including urinary, colorectal-anal, and pelvic organ prolapse-related symptoms, using the Pelvic Floor Distress Inventory-20 (PFDI-20).

    Time frame: At baseline (third trimester of pregnancy) and at 6 weeks postpartum.

Secondary outcomes

  1. Mind-Body Index during Labor

    The Mind-Body Index was assessed using the HeartMath device to evaluate changes in mind-body coherence during labor. Measurements were obtained at two time points during active labor and compared between the intervention and control groups.

    Time frame: At 5-7 cm and 8-9 cm cervical dilation during active labor.

07

Study locations

1 site
  • Ankara Bilkent Şehir Hastanesi
    Ankara, Ankara 06800, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Jun 2026, 5 months.

Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 5 months is below that.

Counting every sponsor, half of 107 studies reached it within 17 months; a quarter within 7 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2024
First posted
Aug 18, 2026
StartActual
Jan 15, 2026
Primary completionActual
Jun 15, 2026
CompletionActual
Jun 15, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07771647
Responsible party
Gurbet Yetiskin Erogul (Principal Investigator, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Aug 18, 2026
Start date
Jan 15, 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026
Last update
Aug 20, 2026

Study contacts

Hüsniye Dinç Kaya, PhD
principal investigator · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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