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

NCT05032456 | Completed

• 1 other identifier: 2020-18/07
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Labor; Immersive Virtual Reality; Non-pharmacologic Treatment; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• Virtual Reality Satisfaction Survey

  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.

  During the intervention

• Wong-Baker Faces Pain

  Pain scores both in early and active labor in each group were assessed using Wong-Baker Faces Pain Rating Scale. The scale shows a series of 6 faces ranging from a happy face at 0, or "no hurt", to a crying face at 5, which represents "hurts like the worst pain

  During the intervention

• Visual Analog Scale (VAS)

  Patient satisfaction with overall labor and delivery experience was assessed using a Visual Analog Scale (VAS). Zero indicates the most negative experience possible and 10 indicates the highest satisfaction possible.

  A week after the labor

Secondary Outcomes (2)

• Beck Anxiety Inventory (BAI)

  Pre-intervention, on admission

• Beck Depression Inventory (BDI)

  Pre-intervention, on admission

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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).

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

Control Group

NO INTERVENTION

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.

Interventions

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

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Being female and having singleton pregnancy at 37-41 weeks gestation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bahçeşehir University: lead
• Acibadem Maslak Hospital: collaborator

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

Location

Related Publications (34)

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MeSH Terms

Conditions

Labor Pain; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. Dr. Selen Gür Özmen

Model Details: 42 laboring women allocated to intervention group and control group randomly

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: September 2, 2021
• Study Start: November 13, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 14, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

TU (1)