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

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Labor, Immersive Virtual Reality, Non-pharmacologic Treatment, Anxiety, Depression

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Acibadem Maslak Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Group

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Beck Anxiety Inventory (BAI)
Anxiety levels of study participants were assessed with Beck Anxiety Inventory (BAI). [19] This inventory consists of 21 items, each scored from 0 to 3. This is a self-report questionnaire measuring somatic and cognitive parts of anxiety. The total score is calculated by finding the sum of 21 items. A score of 0 to 7 indicates minimal anxiety, 8 to 15 mild anxiety, 16 to 25 moderate anxiety, and 30 to 63 is associated with severe anxiety.
Beck Depression Inventory (BDI)
It consists of 21 items which is a multiple-choice test and give a score ranging from 0 to 63. Each answer is scored on a scale value of 0-3. Measures of 0-9 indicate that a person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.

Full Information

First Posted
July 20, 2021
Last Updated
August 26, 2021
Sponsor
Bahçeşehir University
Collaborators
Acibadem Maslak Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05032456
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University
Collaborators
Acibadem Maslak Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Labor, Immersive Virtual Reality, Non-pharmacologic Treatment, Anxiety, Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
42 laboring women allocated to intervention group and control group randomly
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Virtual Reality Satisfaction Survey
Description
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.
Time Frame
During the intervention
Title
Wong-Baker Faces Pain
Description
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
Time Frame
During the intervention
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
A week after the labor
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Description
Anxiety levels of study participants were assessed with Beck Anxiety Inventory (BAI). [19] This inventory consists of 21 items, each scored from 0 to 3. This is a self-report questionnaire measuring somatic and cognitive parts of anxiety. The total score is calculated by finding the sum of 21 items. A score of 0 to 7 indicates minimal anxiety, 8 to 15 mild anxiety, 16 to 25 moderate anxiety, and 30 to 63 is associated with severe anxiety.
Time Frame
Pre-intervention, on admission
Title
Beck Depression Inventory (BDI)
Description
It consists of 21 items which is a multiple-choice test and give a score ranging from 0 to 63. Each answer is scored on a scale value of 0-3. Measures of 0-9 indicate that a person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.
Time Frame
Pre-intervention, on admission

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Being female and having singleton pregnancy at 37-41 weeks gestation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Acibadem Maslak Hospital
City
Istanbul
State/Province
Sariyer
ZIP/Postal Code
34457
Country
Turkey

12. IPD Sharing Statement

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

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