- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07820904
THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
This randomized controlled trial aims to evaluate the effects of 360-degree video-supported upright birth position education on fear of childbirth, childbirth self-efficacy, birth satisfaction, and perineal trauma among primiparous pregnant women. Eligible participants will be randomly assigned to one of three intervention groups or a control group. In addition to routine antenatal care, participants in the intervention groups will receive 360-degree video-supported education on one of three upright birth positions: use of a Pilates ball, birth dance, or squatting. Participants in the control group will receive routine antenatal care only.
The study will examine whether 360-degree video-supported education can help primiparous women prepare for childbirth, reduce fear of childbirth, improve childbirth self-efficacy and birth satisfaction, and reduce the occurrence of perineal trauma. The outcomes of the three intervention groups will also be explored to determine whether the effects differ according to the type of upright birth position.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rozerin Balcı
- Phone Number: +905398339950
- Email: rbalci@beu.edu.tr
Study Locations
-
-
Bitlis
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Bitlis, Bitlis, Turkey (Türkiye)
- Bitlis State Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having signed the Informed Consent Form.
- Being able to speak and understand Turkish.
- Being literate.
- Having no impairment that would interfere with auditory, visual, or cognitive communication.
- Being primiparous.
- Having a singleton live fetus.
- Being between 28 and 32 weeks of gestation.
- Having a fetus in cephalic presentation.
- Planning a vaginal birth.
- Being enrolled and randomized before the onset of labor.
- Being able to use a smartphone or tablet.
- Having sufficient physical and cognitive ability to watch the 360° video education.
- Having moderate fear of childbirth, defined as a score of 38 or higher on the W-DEQ-A.
Exclusion Criteria:
- Refusal to participate in the study or withdrawal from the study.
- Development of a serious maternal or fetal complication during labor that prevents continuation of the study intervention.
- Giving birth by elective or emergency cesarean section.
- Loss of study data during the research process.
- Giving birth outside Bitlis State Hospital.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates Ball Group
Participants will receive 360° video-supported education on upright birth positions using a Pilates ball.
|
Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
|
|
Experimental: Birth Dance Group
Participants will receive 360° video-supported education on upright birth positions using birth dance.
|
Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
|
|
Experimental: Squatting Group
Participants will receive 360° video-supported education on upright birth positions using supported squatting.
|
Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
|
|
No Intervention: Control Group
Participants will receive routine antenatal care without the 360° video-supported upright birth positions education during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Childbirth Fear Score
Time Frame: From baseline (before randomization) to 24-48 hours after childbirth
|
Childbirth fear will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire-A (W-DEQ-A) before randomization and the W-DEQ-B after childbirth.
The change in childbirth fear score will be compared between the study groups.
|
From baseline (before randomization) to 24-48 hours after childbirth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Childbirth Self-Efficacy Score
Time Frame: From baseline (before randomization) to 24-48 hours after childbirth
|
Childbirth self-efficacy will be assessed using the Childbirth Self-Efficacy Scale before randomization and within 24-48 hours after childbirth.
The change in score will be compared between the study groups.
|
From baseline (before randomization) to 24-48 hours after childbirth
|
|
Birth Satisfaction Score
Time Frame: Within 24-48 hours after childbirth
|
Birth satisfaction will be assessed using the Birth Satisfaction Scale Short Form within 24-48 hours after childbirth.
|
Within 24-48 hours after childbirth
|
|
Perineal Trauma
Time Frame: Immediately after childbirth
|
Perineal trauma will be assessed immediately after childbirth during routine clinical evaluation and classified according to the Sultan classification as intact perineum, episiotomy, or first-, second-, third-, or fourth-degree perineal laceration.
|
Immediately after childbirth
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BEU-MIDWIFERY-VIRTUAL-BIRTH-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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