Virtual Reality Effect on Labor Pain and Satisfaction

March 12, 2022 updated by: zeliha sunay, Inonu University

The Effect of Virtual Reality Applications in Travail on Perceived Labor Pain and Satisfaction in Primiparous: A Design Based Study

The primiparous women wore virtual glasses during labor, playing games and exercising. pregnant women were divided into two groups. Experimental and control groups each consisted of 60 pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: The research was carried out to determine the effect of virtual reality application in labor on perceived labor pain and satisfaction levels in primiparous.

Material and Method: The study was conducted in a randomized controlled manner with a total of 120 primiparous women who applied to the delivery room of Elazig Fethi Sekin City Hospital between June 2020 and June 2021 (60 Experiments, 60 Controls). The pregnant women in the experimental group were played by the researcher during the active and transitional phases of labor with virtual reality glasses, which were designed for research and included methods used to cope with labor pain. Except for routine care, no application was made to the pregnant women in the control group. In order to determine the pain level of the pregnant women, SDS and SCS were applied four times, before and after the Virtual Reality applications. After delivery, DME-C was applied to both groups.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All pregnant women who were able to communicate verbally
  • Between 37-42 weeks of pregnancy
  • Single, live fetus and head presentation
  • Cervical opening <4 cm based on the labor follow-up form at admission to the delivery room, were included in the sample

Exclusion Criteria:

  • Women with a risky pregnancy diagnosis (such as preeclampsia, placenta previa, gestational diabetes)
  • Obstetric complications in labor (such as fetal distress, bleeding)
  • Visual and hearing problems
  • Any pharmacological pain-reducing method applied, were excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: experimental group
virtual reality application
Other: Virtual Reality Application
The pregnant women in the experimental group were played by the researcher during the active and transitional phases of labor with virtual reality glasses, which were designed for research and included methods used to cope with labor pain
No Intervention: control group
standard care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain score within one hour during the latent phase
Time Frame: SDS was applied as a pre-test to all pregnant women in both groups in the latent phase. One hour later, it was applied to all pregnant women in both groups as a post-test.
In order to determine the pain level of the pregnant women, SDS was applied four times, before and after the Virtual Reality applications in the latent and active phases. SDS is rated from Scale 0 (zero) to 10 (ten). In the scale, 0 (zero) means no pain, 10 (ten) means unbearable pain. The person can mark according to the severity of the pain on this scale.
SDS was applied as a pre-test to all pregnant women in both groups in the latent phase. One hour later, it was applied to all pregnant women in both groups as a post-test.
change in pain score within one hour during the the active phase
Time Frame: SDS was applied as a pre-test to all pregnant women in both groups in the active phase. One hour later, it was applied to all pregnant women in both groups as a post-test.
In order to determine the pain level of the pregnant women, SDS was applied four times, before and after the Virtual Reality applications in the latent and active phases. SDS is rated from Scale 0 (zero) to 10 (ten). In the scale, 0 (zero) means no pain, 10 (ten) means unbearable pain. The person can mark according to the severity of the pain on this scale.
SDS was applied as a pre-test to all pregnant women in both groups in the active phase. One hour later, it was applied to all pregnant women in both groups as a post-test.
change in pain score within one hour during the latent phase
Time Frame: SCS was applied as a pre-test to all pregnant women in both groups in the latent phase. One hour later, it was applied to all pregnant women in both groups as a post-test.
In order to determine the pain level of the pregnant women, SCS was applied four times, before and after the Virtual Reality applications in the latent and active phases. This scale is based on the person choosing the most appropriate word to describe the pain condition. Pain intensity ranges from mild to unbearable. The severity of pain is defined in five categories and is scored as (1) "mild", (2) "disturbing", (3) "severe", (4) "very severe", and (5) "unbearable". The advantages of the scale are that it is easy to apply and simple to classify.
SCS was applied as a pre-test to all pregnant women in both groups in the latent phase. One hour later, it was applied to all pregnant women in both groups as a post-test.
change in pain score within one hour during the the active phase
Time Frame: SCS was applied as a pre-test to all pregnant women in both groups in the active phase. One hour later, it was applied to all pregnant women in both groups as a post-test.
In order to determine the pain level of the pregnant women, SCS was applied four times, before and after the Virtual Reality applications in the latent and active phases. This scale is based on the person choosing the most appropriate word to describe the pain condition. Pain intensity ranges from mild to unbearable. The severity of pain is defined in five categories and is scored as (1) "mild", (2) "disturbing", (3) "severe", (4) "very severe", and (5) "unbearable". The advantages of the scale are that it is easy to apply and simple to classify.
SCS was applied as a pre-test to all pregnant women in both groups in the active phase. One hour later, it was applied to all pregnant women in both groups as a post-test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: zeliha sunay, Phd, munzur üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

November 8, 2021

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

we don't share individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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