An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth

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

Study Overview

• Status: Completed
• Conditions: An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth
• Intervention / Treatment: Device: Virtual Reality

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharabia
    • Tanta, Gharabia, Egypt, 31511
      • Menshawy general hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: An experimental study on the effect of virtual reality glasses on women during childbirth	Device: Virtual Reality; Studying the effect of virtual reality glasses on women during pregnancy, for the first time, it is also used to facilitate the birth process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Fayiz Elshamy Elshamy Fayiz Elshamy, Professor of physical therapy, Fayiz Elshamy

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: KFS IRB200-91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No