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Completed

NCT Number: NCT07771647

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental Toughness

Behavioral

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

Primary outcomes

  1. Pelvic Floor Distress Inventory- 20

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

    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).

Secondary outcomes

  1. Mind-Body Index during Labor

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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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