Virtual Reality Effect on Labor Pain and Satisfaction

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT05280327
Collaborator
(none)
120
1
2
17.2
7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Reality Application
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Virtual Reality Applications in Travail on Perceived Labor Pain and Satisfaction in Primiparous: A Design Based Study
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Nov 8, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change in pain score within one hour during the latent phase [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.

  2. change in pain score within one hour during the the active phase [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.

  3. change in pain score within one hour during the latent phase [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.

  4. change in pain score within one hour during the the active phase [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 İnönü University Malatya Turkey

Sponsors and Collaborators

  • Inonu University

Investigators

  • Principal Investigator: zeliha sunay, Phd, munzur üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
zeliha sunay, Principal Investigator, Inonu University
ClinicalTrials.gov Identifier:
NCT05280327
Other Study ID Numbers:
  • 2020/603
First Posted:
Mar 15, 2022
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by zeliha sunay, Principal Investigator, Inonu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022