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OpenTrials
Completed

NCT Number: NCT07771647

THE EFFECT OF MENTAL TOUGHNESS INTERVENIONS DURİNG BIRTH ON THE PELVIC FLOOR IN THE POSTPARTUM PERIOD

Aim: The aim of this study is to determine the effect of mental resilience interventions performed during the childbirth process (breathing exercises, relaxation exercises, focusing/concentration, and imagery) on the pelvic floor in the postpartum period.

Original Value: No study has been found that examines the effect of implementing mental resilience interventions from the third trimester of pregnancy on postpartum pelvic floor muscle strength and functions.

Method: In the study, the sample size was calculated prior to data collection using the G*Power 3.1.9.2 program at a 95% confidence level. Since no study could be found in the literature that could be used as a reference for the research objective, an effect size of 0.80-the lower limit of the high effect size range-was used to calculate the sample size for the difference between two groups. Accordingly, with an alpha value of 0.05 and a theoretical power of 0.80, the minimum sample size was calculated as 52 (Experimental Group = 26, Control Group = 26). In the study, the Descriptive Information Form, the Birth and Postpartum Information Form, and the Pelvic Floor Distress Inventory-20, which were prepared in line with the literature, will be used.

Management: Obtaining ethics committee permission, creating forms before data collection, collecting data, creating data sets of the data obtained, analyzing the data and reporting the findings obtained and making them available on scientific platforms have been determined as work packages within the scope of the management of the project and the total duration of the work packages is 24 months.

Widespread Impact: The reference results of the study planned within the project will be presented on scientific platforms as at least one national/international article and declaration.

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Key information

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 18, 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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