Clinical trial NCT05280327: 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
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction
Labor Pain
Keywords: Primiparous
Birth Pain
Birth Satisfaction
Virtual Reality
Midwifery
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: change in pain score within one hour during the latent phase
timeFrame: 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.
measure: change in pain score within one hour during the the active phase
timeFrame: 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.
measure: change in pain score within one hour during the latent phase
timeFrame: 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.
measure: change in pain score within one hour during the the active phase
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: İnönü University
Study officials:
affiliation: munzur üniversitesi
name: zeliha sunay, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.