NCT07820904

Brief Summary

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.

Trial Health

63
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Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

September 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 10, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

primiparous pregnancy, childbirth fear, childbirth self-efficacy, birth satisfaction, perineal trauma, 360-degree video

Outcome Measures

Primary Outcomes (1)

  • Change in Childbirth Fear Score

    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 Outcomes (3)

  • Change in Childbirth Self-Efficacy Score

    From baseline (before randomization) to 24-48 hours after childbirth

  • Birth Satisfaction Score

    Within 24-48 hours after childbirth

  • Perineal Trauma

    Immediately after childbirth

Study Arms (4)

Pilates Ball Group

EXPERIMENTAL

Participants will receive 360° video-supported education on upright birth positions using a Pilates ball.

Behavioral: 360° Video-Supported Upright Birth Positions Education

Birth Dance Group

EXPERIMENTAL

Participants will receive 360° video-supported education on upright birth positions using birth dance.

Behavioral: 360° Video-Supported Upright Birth Positions Education

Squatting Group

EXPERIMENTAL

Participants will receive 360° video-supported education on upright birth positions using supported squatting.

Behavioral: 360° Video-Supported Upright Birth Positions Education

Control Group

NO INTERVENTION

Participants will receive routine antenatal care without the 360° video-supported upright birth positions education during the study period.

Interventions

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.

Birth Dance GroupPilates Ball GroupSquatting Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis State Hospital

Bitlis, Bitlis, Turkey (Türkiye)

Location

Central Study Contacts

Rozerin Balcı

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of four parallel groups: Pilates ball, birth dance, squatting, or control. Each group will include 23 participants. The three intervention groups will receive 360-degree video-supported education on the assigned upright birth position in addition to routine antenatal care, while the control group will receive routine antenatal care only. Outcomes will be compared between the four groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Midwifery

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 15, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations