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Completed

NCT Number: NCT05280327

Virtual Reality Effect on Labor Pain and Satisfaction

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.

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Key information

Conditions

Satisfaction Behavior Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

İnönü University

Malatya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2022
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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