MeditationNCT07201220
Meditation in Early Labor: Impact on Self-Efficacy and Childbirth Fear in First-Time Mothers
A study testing meditation in people with Meditation, run by Seyhan District Health Directorate, Adana at 2 sites in Turkey (Türkiye).
Trial 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. 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
- Meditation
- What is being tested?
- meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Multiparous women
- High-risk pregnancy
- Previous experience with meditation during labor
- Communication difficulties
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Seyhan İlçe Sağlık Müdürlüğü
Adana, Adana
EMEL SALCAN, 05061727755, emelsalcan01@gmail.com
- Recruiting
Seyhan İlçe Sağlık Müdürlüğü
Seyhan, Adana
EMEL SALCAN, 05061727755, emelsalcan01@gmail.com
About this study
Official title: The Effect of Relaxation Meditation During the First Stage of Labor on Childbirth Self-Efficacy and Fear in Primiparous Women: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Introduction:
This study aims to examine whether there are significant differences in childbirth self-efficacy and fear of childbirth between primiparous pregnant women who practice meditation (experimental group) and those who do not (control group) during the first stage of labor. Childbirth is a physiological process for every woman, but feelings of uncertainty, perceived inadequacy, anxiety, and stress can lead to fear of childbirth and avoidance behavior. Studies show that 6.3-75% of pregnant women experience fear of childbirth, with 6-10% affected severely. This fear can be influenced by biological, psychological, social, and secondary factors such as previous traumatic experiences or negative birth stories. Furthermore, gestational age and parity also play important roles in the emergence of birth fear.
Fear of childbirth can result in complications such as prolonged labor, emergency or elective cesarean delivery, postpartum depression, post-traumatic stress disorder, and disruption in mother-infant bonding. Various methods, including cognitive-behavioral techniques, psychoeducation, and relaxation therapies like hypnobirthing, are used to manage this fear. Research suggests that birth fear is not solely linked to pain or information deficits but to many other factors, including a woman's sense of self-efficacy.
Self-efficacy refers to a person's belief in their ability to complete tasks or overcome challenges. A woman with high self-efficacy is more likely to manage stress-inducing situations, such as labor, by trusting her own capabilities. Increasing self-efficacy and reducing fear of childbirth can be achieved through relaxation techniques, one of which is meditation. Meditation involves mental training that helps individuals find strength and solutions to problems, promoting relaxation that may alleviate both mental and physical tension. During pregnancy and labor, meditation can assist in reducing anxiety and enhancing positive birth experiences.
Aim:
The study aims to investigate whether relaxation through meditation in the first stage of labor can enhance self-efficacy and reduce fear of childbirth in primiparous women, contributing to a less stressful and anxious labor process. Gestational age and parity are known to influence childbirth fear. The research will evaluate whether meditation can help reduce anxiety and foster self-efficacy, aiding in a more manageable birth experience.
Research Problem:
Does a significant difference exist between the self-efficacy and fear of childbirth of primiparous women who receive meditation during the first stage of labor and those who do not?
Keywords: Primiparous pregnancy, Meditation, Childbirth Self-Efficacy, Fear of Childbirth.
- Conditions
- Meditation
- Being tested
- meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Fear of childbirth is assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A). The scale is applied before the relaxation meditation during the active phase of the first stage of labor and re-applied 1 hour after the intervention. The change in scores reflects the effect of the intervention on fear of childbirth.intervention and re-administered within 24 hours after delivery to evaluate changes in fear levels among participants.
Measured: From the beginning of the active phase of the first stage of labor to 1 hour after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeditationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seyhan District Health Directorate, Adana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMEL SALCAN, Seyhan District Health Directorate, Adana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201220
- Sponsor's protocol ID
- 2022.03.06/123
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxation Meditation During the First Stage of Labor on Childbirth Self-Efficacy and Fear in Primiparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07201220
- Acronym / sponsor ID
- 2022.03.06/123
- Conditions
- Meditation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seyhan District Health Directorate, AdanaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 1 Oct 2025 (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.
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.
Detailed description
Introduction:
This study aims to examine whether there are significant differences in childbirth self-efficacy and fear of childbirth between primiparous pregnant women who practice meditation (experimental group) and those who do not (control group) during the first stage of labor. Childbirth is a physiological process for every woman, but feelings of uncertainty, perceived inadequacy, anxiety, and stress can lead to fear of childbirth and avoidance behavior. Studies show that 6.3-75% of pregnant women experience fear of childbirth, with 6-10% affected severely. This fear can be influenced by biological, psychological, social, and secondary factors such as previous traumatic experiences or negative birth stories. Furthermore, gestational age and parity also play important roles in the emergence of birth fear.
Fear of childbirth can result in complications such as prolonged labor, emergency or elective cesarean delivery, postpartum depression, post-traumatic stress disorder, and disruption in mother-infant bonding. Various methods, including cognitive-behavioral techniques, psychoeducation, and relaxation therapies like hypnobirthing, are used to manage this fear. Research suggests that birth fear is not solely linked to pain or information deficits but to many other factors, including a woman's sense of self-efficacy.
Self-efficacy refers to a person's belief in their ability to complete tasks or overcome challenges. A woman with high self-efficacy is more likely to manage stress-inducing situations, such as labor, by trusting her own capabilities. Increasing self-efficacy and reducing fear of childbirth can be achieved through relaxation techniques, one of which is meditation. Meditation involves mental training that helps individuals find strength and solutions to problems, promoting relaxation that may alleviate both mental and physical tension. During pregnancy and labor, meditation can assist in reducing anxiety and enhancing positive birth experiences.
Aim:
The study aims to investigate whether relaxation through meditation in the first stage of labor can enhance self-efficacy and reduce fear of childbirth in primiparous women, contributing to a less stressful and anxious labor process. Gestational age and parity are known to influence childbirth fear. The research will evaluate whether meditation can help reduce anxiety and foster self-efficacy, aiding in a more manageable birth experience.
Research Problem:
Does a significant difference exist between the self-efficacy and fear of childbirth of primiparous women who receive meditation during the first stage of labor and those who do not?
Keywords: Primiparous pregnancy, Meditation, Childbirth Self-Efficacy, Fear of Childbirth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A Randomized Controlled Experimental Study | Experimental | Behavioral: meditationExperimental 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primiparous pregnant women
- In the first stage of labor
- Singleton pregnancy
- Aged 18 and above
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Multiparous women
- High-risk pregnancy
- Previous experience with meditation during labor
- Communication difficulties
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 |
|---|---|---|
| meditationThe 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. | Behavioural | A Randomized Controlled Experimental Study |
Primary outcome
Change in perceived childbirth self-efficacy measured by the Childbirth Self-Efficacy Inventory Short Form (CBSEI-SF)
Time frame: From the beginning of the active phase of the first stage of labor to 1 hour after the intervention
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.
1 secondary outcome
Change in fear of childbirth measured by the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)
Time frame: From the beginning of the active phase of the first stage of labor to 1 hour after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meditation in people with Meditation, run by Seyhan District Health Directorate, Adana at 2 sites 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived childbirth self-efficacy measured by the Childbirth Self-Efficacy Inventory Short Form (CBSEI-SF) (time frame: From the beginning of the active phase of the first stage of labor to 1 hour after the intervention). 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 1 Oct 2025.