Virtual Reality Effect on Labor Pain and Satisfaction

NCT05280327 | Completed

• 1 other identifier: 2020/603
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction; Labor Pain

Keywords

Primiparous; Birth Pain; Birth Satisfaction; Virtual Reality; Midwifery

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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

  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.

Study Arms (2)

experimental group

EXPERIMENTAL

virtual reality application

Other: Virtual Reality Application

control group

NO INTERVENTION

standard care group

Interventions

Virtual Reality Application OTHER

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

experimental group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

İnönü University

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33478718 RESULT

MeSH Terms

Conditions

Personal Satisfaction; Labor Pain

Condition Hierarchy (Ancestors)

Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• zeliha sunay, Phd

  munzur üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: March 15, 2022
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: November 8, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)