PregnancyNCT07771647
The Effect of Mental Toughness Interventions During Birth on the Pelvic Floor in the Postpartum Period
A study testing Mental Toughness in people with Pregnancy and Labor Delivery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Labor Delivery, Breath Exercise
- What is being tested?
- Mental Toughness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being primiparous
- Being in the third trimester of pregnancy
- Having no communication barriers
- Being a pregnant woman with an expectation of vaginal delivery
Who cannot join
- 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:
Show all 9Show fewer
- Voluntary withdrawal from the study by the participant
- Emergency cesarean delivery decision
- Impairment of mental functions during the intrapartum or postpartum period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent Şehir Hastanesi
Ankara, Ankara, 06800
About this study
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.
- Conditions
- Pregnancy, Labor Delivery, Breath Exercise, Relaxation, Focus Health Pregancy Women, Imagery, Psychotherapy
- Being tested
- Mental Toughness
- Keywords
- Mental Toughness, Labor, Pelvic Floor
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental ToughnessBehavioural
breathing exercises, relaxation techniques, focusing/concentration practices, and imagery
| Study group | Role | What they receive |
|---|---|---|
| Mental Toughness Intervenıons | Experimental | 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." Receives: Behavioral: Mental Toughness |
| Control Group | No intervention | Routine care will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At 5-7 cm and 8-9 cm cervical dilation during active labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Jan 2026
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurbet Yetiskin Erogul, Istanbul University - Cerrahpasa
- Investigators
- Hüsniye Dinç Kaya, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771647
- Sponsor's protocol ID
- TABED 1-25-1761
- Status last verified
- Aug 2026
- First submitted
- 31 May 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mental Toughness Interventions During Birth on the Pelvic Floor in the Postpartum Period
- ClinicalTrials.gov ID
- NCT07771647
- Acronym / sponsor ID
- TABED 1-25-1761
- Conditions
- Pregnancy, Labor Delivery, Breath Exercise, Relaxation, Focus Health Pregancy Women, Imagery, Psychotherapy
- Keywords
- Mental Toughness, Labor, Pelvic Floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mental Toughness Intervenıons | Experimental | Behavioral: Mental ToughnessThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being primiparous
- Being in the third trimester of pregnancy
- Having no communication barriers
- Being a pregnant woman with an expectation of vaginal delivery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Toughnessbreathing exercises, relaxation techniques, focusing/concentration practices, and imagery | Behavioural | Mental Toughness Intervenıons |
Primary outcome
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).
1 secondary outcome
Mind-Body Index during Labor
Time frame: At 5-7 cm and 8-9 cm cervical dilation during active labor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hüsniye Dinç Kaya, PhD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Toughness in people with Pregnancy and Labor Delivery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Distress Inventory- 20 (time frame: At baseline (third trimester of pregnancy) and at 6 weeks postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.