NCT06677463

Brief Summary

This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 20, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

10 days

First QC Date

October 30, 2024

Last Update Submit

November 5, 2024

Conditions

An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth

Outcome Measures

Primary Outcomes (3)

  • Serum cortisol levels

    Serum cortisol levels during the normal labor

    Immediately after the intervention

  • Time of labor

    Measure the time of labor after delivery

    Immediately after the intervention

  • Type of labor normal , cesarean section or episiotomy

    Type of delivery

    Immediately after the intervention

Study Arms (1)

An experimental study on the effect of virtual reality glasses on women during childbirth

EXPERIMENTAL

An experimental study on the effect of virtual reality glasses on women during childbirth

Device: Virtual Reality

Interventions

Virtual RealityDEVICE

Studying the effect of virtual reality glasses on women during pregnancy, for the first time, it is also used to facilitate the birth process

An experimental study on the effect of virtual reality glasses on women during childbirth

Eligibility Criteria

Age20 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe pregnant woman during normal labor
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-25 years old .
  • body mass index (BMI) 25- 32 kg/m2 .
  • Primiparous .
  • Highly educated.

You may not qualify if:

  • Laboring women with high risk pregnancy.
  • Laboring women are taking pharmacological methods to relieve pain during first stage of labor.
  • Low educated women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menshawy general hospital

Tanta, Gharabia, 31511, Egypt

Location

Study Officials

  • Fayiz Elshamy Elshamy Fayiz Elshamy, Professor of physical therapy

    Fayiz Elshamy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapy specialist for women health

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 6, 2024

Study Start

October 20, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

These pregnant women were asked to bring their phone that the video was recorded with them to the labour. When the pregnant women got into labour, they would hospitalized . The follow-ups and labour will also performed . These two-dimensional images will converted into three-dimensional images through an application installed in the mother's phone and will showe to her with a VR Box 3D virtual reality glass one after another. In cases where the program was not compatible with the mother's phone, it will watched on the researcher's phone. The total duration of image viewing was recorded. Procedure of application of virtual reality from cervical dilatation 3 cm to full dilatation

Locations

EG(1)