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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05032456
Recruitment Status : Completed
First Posted : September 2, 2021
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
Acibadem Maslak Hospital
Information provided by (Responsible Party):
Assoc. Prof. Dr. Selen Gür Özmen MD Phd, Bahçeşehir University

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.

Condition or disease Intervention/treatment Phase
Labor Pain Device: Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 42 laboring women allocated to intervention group and control group randomly
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Immersive Virtual Reality Improves Satisfaction In Laboring Women
Actual Study Start Date : November 13, 2020
Actual Primary Completion Date : June 10, 2021
Actual Study Completion Date : June 14, 2021

Arm Intervention/treatment
Experimental: 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).
Device: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Virtual Reality Satisfaction Survey [ Time Frame: During the intervention ]
    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.

  2. Wong-Baker Faces Pain [ Time Frame: During the intervention ]
    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

  3. Visual Analog Scale (VAS) [ Time Frame: A week after the labor ]
    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 :
  1. Beck Anxiety Inventory (BAI) [ Time Frame: Pre-intervention, on admission ]
    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.

  2. Beck Depression Inventory (BDI) [ Time Frame: Pre-intervention, on admission ]
    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.



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Being female and having singleton pregnancy at 37-41 weeks gestation
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032456


Locations
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Turkey
Acibadem Maslak Hospital
Istanbul, Sariyer, Turkey, 34457
Sponsors and Collaborators
Bahçeşehir University
Acibadem Maslak Hospital
  Study Documents (Full-Text)

Documents provided by Assoc. Prof. Dr. Selen Gür Özmen MD Phd, Bahçeşehir University:
Study Protocol  [PDF] August 24, 2021

Publications:
Beck AT, Steer RA, Carbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review. 1988.
Ashagrie HE, Fentie DY, Kassahun HG. A review article on epidural analgesia for labor pain management: A systematic review. International Journal of Surgery Open. 2020;24:100-4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assoc. Prof. Dr. Selen Gür Özmen MD Phd, Assoc.Prof. Dr. Selen Gür Özmen, Bahçeşehir University
ClinicalTrials.gov Identifier: NCT05032456    
Other Study ID Numbers: 2020-18/07
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assoc. Prof. Dr. Selen Gür Özmen MD Phd, Bahçeşehir University:
Labor
Immersive Virtual Reality
Non-pharmacologic Treatment
Anxiety
Depression
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations