NCT07201220

Brief Summary

Aim-Introduction: The feeling of uncertainty about what will happen during labor, and the mother's perception of inadequacy regarding childbirth, can lead to anxiety and stress in some pregnant women, resulting in fear of childbirth and avoidance behaviors. This study was conducted to examine whether there are significant differences in childbirth self-efficacy and fear of childbirth between primiparous pregnant women who practiced meditation and those who did not during the first stage of labor. Materials and Methods: This experimental study is planned to be conducted between 01.04.2025 and 01.08.2025 with a total of 60 pregnant women (30 in the experimental group and 30 in the control group) who applied to the delivery unit of a tertiary hospital in Turkey and were in the first stage of labor. After informing the pregnant women about the study and the procedures to be implemented, written informed consent was obtained from those who agreed to participate. Subsequently, the pre-tests of the relevant scales and the data collection form were administered. The relaxation meditation during childbirth was applied to the experimental group, followed by the post-tests of the same scales. Data were collected using the "Childbirth Self-Efficacy Inventory Short Form" and the "Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) Version A." Descriptive statistics and hypothesis tests will be used for data analysis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 9, 2025

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in perceived childbirth self-efficacy measured by the Childbirth Self-Efficacy Inventory Short Form (CBSEI-SF)

    Perceived childbirth self-efficacy is assessed using the Childbirth Self-Efficacy Inventory Short Form (CBSEI-SF). The scale is administered during the active phase of the first stage of labor (before the intervention), and re-administered 1 hour after relaxation meditation. Change in scores indicates the effect of the intervention on participants' self-efficacy levels.

    From the beginning of the active phase of the first stage of labor to 1 hour after the intervention

Secondary Outcomes (1)

  • Change in fear of childbirth measured by the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)

    From the beginning of the active phase of the first stage of labor to 1 hour after the intervention

Study Arms (1)

A Randomized Controlled Experimental Study

EXPERIMENTAL

Experimental Group: 30 primiparous women in the first stage of labor receive relaxation meditation during labor. Pre- and post-tests using the Childbirth Self-Efficacy Inventory Short Form and W-DEQ Version A are applied. Data collected between 01.04.2025 and 01.08.2025 at a tertiary hospital in Turkey. Control Group: 30 primiparous women in the first stage of labor receive standard care without intervention. The same pre- and post-tests are applied. Data collected in the same period and setting.

Behavioral: meditation

Interventions

meditationBEHAVIORAL

The study is planned to include 60 pregnant women (30 in the experimental group and 30 in the control group) in the first stage of labor. After informing the participants about the study and obtaining informed consent, pre-test scales will be administered. Relaxation meditation will be applied during labor for the experimental group, followed by post-test scales.

A Randomized Controlled Experimental Study

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous pregnant women
  • In the first stage of labor
  • Singleton pregnancy
  • Aged 18 and above
  • Able to provide informed consent
  • No high-risk pregnancy or psychiatric diagnosis

You may not qualify if:

  • Multiparous women
  • High-risk pregnancy
  • Previous experience with meditation during labor
  • Communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seyhan İlçe Sağlık Müdürlüğü

Adana, Adana, Turkey (Türkiye)

RECRUITING

Seyhan İlçe Sağlık Müdürlüğü

Seyhan, Adana, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: After informing the pregnant women about the study and the procedures to be implemented, informed consent will be obtained from those who agree to participate. Following this, participants will complete the data collection form, and pre-test questionnaires will be administered. Subsequently, relaxation meditation will be played via headphones during labor, and the questionnaires will be applied again as post-tests.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Midwife

Study Record Dates

First Submitted

September 9, 2025

First Posted

October 1, 2025

Study Start

July 1, 2025

Primary Completion

September 30, 2025

Study Completion

October 31, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations