Clinical trial NCT05032456: Immersive Virtual Reality Satisfies the Women in Labor by Distracting Them From Their Labor Pain in Labor on Latent and Active Phase
Official title: Immersive Virtual Reality Improves Satisfaction In Laboring Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Labor
Immersive Virtual Reality
Non-pharmacologic Treatment
Anxiety
Depression
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
Collaborators: name: Acibadem Maslak Hospital
First posted: 2021-09-02
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 42 laboring women allocated to intervention group and control group randomly
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized control study with 42 laboring women allocated to virtual reality intervention and control groups. The objective of this study, to evaluate the effectiveness of immersive virtual reality in laboring women on patient satisfaction and pain relief. The satisfaction of patients was measured with a "Virtual reality satisfaction survey" which was prepared by the investigators. Pain levels were assessed by a virtual pain rating scale in the early and the active phase of labor in both groups.

Detailed description: Labor is a long and painful process for women. For avoiding or alleviating pain, adjuvant treatments such as hydrotherapy, yoga, hypnosis, acupuncture, and relaxation techniques could be used. Recent literature indicates the successful use of immersive virtual reality for a variety of painful medical procedures. Immersive virtual reality is hypothesized to reduce pain through distraction, a non-pharmacologic attentional mechanism. The user's brain is preoccupied with the flood of information presented by the virtual environment restricting the mind from processing pain signals. The investigators hypothesized that laboring women find immersive virtual reality as a beneficial tool for their overall labor and delivery experience. The 42 laboring women were randomized into two arms: virtual reality group ( intervention group) and control group. The investigators used Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system. Before the intervention, the authors introduced the equipment and instructed study participants on how to wear and activate the headsets. Anxiety and depression scales were also applied on admission. The laboring women who enrolled in the VR group first wore the headsets in early labor (Cervical dilation 3 cm) for 20 minutes. The patients were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the images of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance. The second implementation of VR headsets was after the epidural analgesia in the active phase of labor for another 20 minutes (Cervical dilation 6-7cm). After the second intervention, the "Virtual Reality Satisfaction Survey" was applied by the authors. Patients were asked to fill out a visual pain rating scale right before and after the VR use in early and active labor. The primary objective of this study was to assessed whether immersive virtual reality provided pain relief in the latent or active phase of labor. The authors also evaluated anxiety and depression in both groups on admission as potential confounders. Anxiety and depression levels, assessed with the Beck Anxiety Inventory and Beck Depression Inventory. Patient satisfaction with the use of VR was assessed by a "Virtual Reality Satisfaction Survey" 10 question survey prepared by our team: 0 being the lowest and 100 being the highest possible VR satisfaction score.The investigators also asked these women whether the participants would like to use VR in future labor. Patient satisfaction with overall labor and delivery experience was assessed using a Visual Analog Scale (VAS). All discharged women were called a week following discharge and asked to rate their overall childbirth experience on a scale from 0 to 10. Zero indicates the most negative experience possible and 10 indicates the highest satisfaction possible. The authors classified a score of 8 to 10 as high satisfaction. Pain scores both in early and active labor in each group were assessed using Wong-Baker Faces Pain Rating Scale.

Eligibility criteria: Inclusion Criteria:

* 18-42 years of age
* 37-41 week gestation
* A singleton pregnancy
* With vertex presentation
* No history of chronic medical conditions
* Absence of pregnancy complications
* Admission with documented labor by cervical exam and regular uterine contractions.

Exclusion Criteria:

* Migraine
* Headache
* Dizziness
* Motion Sickness
* Epilepsy
* Psychiatric disorders
* Visual or auditory disabilities
* History of cesarean section

Primary outcomes:
measure: Virtual Reality Satisfaction Survey
timeFrame: During the intervention
measure: Wong-Baker Faces Pain
timeFrame: During the intervention
measure: Visual Analog Scale (VAS)
timeFrame: A week after the labor
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Pre-intervention, on admission
measure: Beck Depression Inventory (BDI)
timeFrame: Pre-intervention, on admission
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
state: Sariyer
Study officials:
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