Virtual Reality Effect on Labor Pain and Satisfaction

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280327
• Other study ID #: 2020/603
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: March 2022
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 8, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Satisfaction

Intervention

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

Locations

Country	Name	City	State
Turkey	Inönü University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Gür 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.

External Links

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