Immersive Virtual Reality Satisfies the Women in Labor by Distracting Them From Their Labor Pain in Labor on Latent and Active Phase

NCT ID: NCT05032456

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2021-06-14

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

Investigators used Oculus Quest All-in-one Virtual Reality Gaming Headset (128 GB) VR system. Before the intervention, the investigators introduced the equipment and instructed study participants on how to wear and activate the headsets. The laboring women who enrolled in the virtual reality 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 virtual reality headsets was after the epidural analgesia in the active phase of labor for another 20 minutes (Cervical dilation 6-7cm).

Group Type: EXPERIMENTAL

Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system

Intervention Type: DEVICE

The laboring women who enrolled in the VR group 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 screenshots 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.

Control Group

For participants randomized to the control group, virtual reality headsets were not used and the clinic's standard of care in laboring women was followed. Participants in this group filled out a visual pain rating scale both in the latent and active phases of labor.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system

The laboring women who enrolled in the VR group 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 screenshots 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Acibadem Maslak Hospital

OTHER

Sponsor Role: collaborator

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Assoc. Prof. Dr. Selen Gür Özmen MD Phd

Assoc.Prof. Dr. Selen Gür Özmen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Acibadem Maslak Hospital

Istanbul, Sariyer, Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Document Type: Study Protocol

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Other Identifiers

2020-18/07

Identifier Type: -

Identifier Source: org_study_id