| Registry | NCT07771647 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, health services research |
| Enrollment | 62 (Actual) |
| Sponsor | Istanbul University - Cerrahpasa (Other) |
| Conditions | Pregnancy, Labor Delivery, Breath Exercise, Relaxation, Focus Health Pregancy Women, Imagery, Psychotherapy, Pelvic Floor Disorder, Pelvic Floor Muscle Activation |
| Interventions | Mental Toughness (Behavioral) |
| Dates | start 2026-01-15, primary completion 2026-06-15, completion 2026-06-15, first posted 2026-08-18, last updated 2026-08-20 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Pregnancy All trials for Labor Delivery All trials of Mental Toughness
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mental Toughness Intervenıons | Experimental | Behavioral: Mental Toughness | 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." |
| Control Group | No intervention | Routine care will be given |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Ankara Bilkent Şehir Hastanesi | Ankara, Ankara | Turkey (Türkiye) |