Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07771647
Enrollment
62
Registered
2026-08-18
Start date
2026-01-15
Completion date
2026-06-15
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Mental Toughness, Labor, Pelvic Floor

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.

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.

Interventions

BEHAVIORALMental Toughness

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

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Population and Sample of the Study: 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 62 (Experimental Group = 31, Control Group = 31). \*\*Inclusion Criteria of the Study:\*\* * Being primiparous * Being in the 3rd trimester of pregnancy * Having no communication barriers * Pregnant women expecting a vaginal birth

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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 outcomes

Primary

MeasureTime frameDescription
Pelvic Floor Distress Inventory- 20At 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

MeasureTime frameDescription
Mind-Body Index during LaborAt 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORHüsniye Dinç Kaya, PhD

Istanbul University - Cerrahpasa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026