Immersive Virtual Reality Satisfies the Women in Labor by Distracting Them From Their Labor Pain in Labor on Latent and Active Phase
Immersive Virtual Reality Improves Satisfaction In Laboring Women
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sariyer
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Istanbul, Sariyer, Turkey, 34457
- Acibadem Maslak Hospital
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Virtual Reality Satisfaction Survey
Time Frame: During the intervention
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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.
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During the intervention
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Wong-Baker Faces Pain
Time Frame: During the intervention
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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
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During the intervention
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Visual Analog Scale (VAS)
Time Frame: A week after the labor
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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.
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A week after the labor
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Pre-intervention, on admission
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Beck Depression Inventory (BDI)
Time Frame: Pre-intervention, on admission
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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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Pre-intervention, on admission
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
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- ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.
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- Gau ML, Chang CY, Tian SH, Lin KC. Effects of birth ball exercise on pain and self-efficacy during childbirth: a randomised controlled trial in Taiwan. Midwifery. 2011 Dec;27(6):e293-300. doi: 10.1016/j.midw.2011.02.004. Epub 2011 Apr 3.
- Nanji JA, Carvalho B. Pain management during labor and vaginal birth. Best Pract Res Clin Obstet Gynaecol. 2020 Aug;67:100-112. doi: 10.1016/j.bpobgyn.2020.03.002. Epub 2020 Mar 7.
- Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.
- Madden K, Middleton P, Cyna AM, Matthewson M, Jones L. Hypnosis for pain management during labour and childbirth. Cochrane Database Syst Rev. 2016 May 19;2016(5):CD009356. doi: 10.1002/14651858.CD009356.pub3.
- Smith CA, Levett KM, Collins CT, Dahlen HG, Ee CC, Suganuma M. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009290. doi: 10.1002/14651858.CD009290.pub3.
- Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. J Trauma. 2011 Jul;71(1 Suppl):S125-30. doi: 10.1097/TA.0b013e31822192e2.
- Atzori B, Lauro Grotto R, Giugni A, Calabro M, Alhalabi W, Hoffman HG. Virtual Reality Analgesia for Pediatric Dental Patients. Front Psychol. 2018 Nov 23;9:2265. doi: 10.3389/fpsyg.2018.02265. eCollection 2018.
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- Wang YL, Gao HX, Wang JS, Wang JH, Bo L, Zhang TT, Dai YL, Gao LL, Liu Q, Zhang JJ, Cai JM, Yu JQ, Li YX. Immersive virtual reality as analgesia for women during hysterosalpingography: study protocol for a randomized controlled trial. Trials. 2020 Jan 20;21(1):102. doi: 10.1186/s13063-019-4023-y.
- Hoffman HG, Richards TL, Coda B, Bills AR, Blough D, Richards AL, Sharar SR. Modulation of thermal pain-related brain activity with virtual reality: evidence from fMRI. Neuroreport. 2004 Jun 7;15(8):1245-8. doi: 10.1097/01.wnr.0000127826.73576.91.
- Beck AT, Steer RA, Carbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review. 1988.
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- Attanasio LB, McPherson ME, Kozhimannil KB. Positive childbirth experiences in U.S. hospitals: a mixed methods analysis. Matern Child Health J. 2014 Jul;18(5):1280-90. doi: 10.1007/s10995-013-1363-1.
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- Tuncalp Ӧ, Were WM, MacLennan C, Oladapo OT, Gulmezoglu AM, Bahl R, Daelmans B, Mathai M, Say L, Kristensen F, Temmerman M, Bustreo F. Quality of care for pregnant women and newborns-the WHO vision. BJOG. 2015 Jul;122(8):1045-9. doi: 10.1111/1471-0528.13451. Epub 2015 May 1. No abstract available.
- Lazzerini M, Mariani I, Semenzato C, Valente EP. Association between maternal satisfaction and other indicators of quality of care at childbirth: a cross-sectional study based on the WHO standards. BMJ Open. 2020 Sep 14;10(9):e037063. doi: 10.1136/bmjopen-2020-037063.
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- 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.
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- Lee SL, Liu CY, Lu YY, Gau ML. Efficacy of warm showers on labor pain and birth experiences during the first labor stage. J Obstet Gynecol Neonatal Nurs. 2013 Jan-Feb;42(1):19-28. doi: 10.1111/j.1552-6909.2012.01424.x. Epub 2012 Nov 20.
- Nieminen K, Stephansson O, Ryding EL. Women's fear of childbirth and preference for cesarean section--a cross-sectional study at various stages of pregnancy in Sweden. Acta Obstet Gynecol Scand. 2009;88(7):807-13. doi: 10.1080/00016340902998436.
- Eyi EGY, Mollamahmutoglu L. An analysis of the high cesarean section rates in Turkey by Robson classification. J Matern Fetal Neonatal Med. 2021 Aug;34(16):2682-2692. doi: 10.1080/14767058.2019.1670806. Epub 2019 Oct 1.
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Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2020-18/07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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