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Virtual Reality Effect on Labor Pain and Satisfaction

Primary Purpose

Satisfaction, Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Application
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Satisfaction focused on measuring Primiparous, Birth Pain, Birth Satisfaction, Virtual Reality, Midwifery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • İnönü University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

virtual reality application

standard care group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 27, 2021
Last Updated
March 12, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05280327
Brief Title
Virtual Reality Effect on Labor Pain and Satisfaction
Official Title
The Effect of Virtual Reality Applications in Travail on Perceived Labor Pain and Satisfaction in Primiparous: A Design Based Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
November 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Satisfaction, Labor Pain
Keywords
Primiparous, Birth Pain, Birth Satisfaction, Virtual Reality, Midwifery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
virtual reality application
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard care group
Intervention Type
Other
Intervention Name(s)
Virtual Reality Application
Intervention Description
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
Primary Outcome Measure Information:
Title
change in pain score within one hour during the latent phase
Description
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.
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.
Title
change in pain score within one hour during the the active phase
Description
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.
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.
Title
change in pain score within one hour during the latent phase
Description
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.
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.
Title
change in pain score within one hour during the the active phase
Description
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.
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.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeliha sunay, Phd
Organizational Affiliation
munzur üniversitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
İnönü University
City
Malatya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
we don't share individual participant data with other researchers
Citations:
PubMed Identifier
33478718
Citation
Gur EY, Apay SE. The effect of cognitive behavioral techniques using virtual reality on birth pain: a randomized controlled trial. Midwifery. 2020 Dec;91:102856. doi: 10.1016/j.midw.2020.102856. Epub 2020 Sep 28.
Results Reference
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Virtual Reality Effect on Labor Pain and Satisfaction

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