Virtual Reality, Experience During Labour; a Qualitative Research (VIREL)

NCT04858984 | Completed

• 1 other identifier: NL-METCZ20200096
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Childbirth is associated with labour pain and can be regarded as one of the most serious kinds of pain. Labour pain management methods include pharmacological and non-pharmacological methods. There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain. The aim of this qualitative study is to explore the experience, preference, and satisfaction of the use of two different VR scenario's during labour. The secondary outcome parameter is the effect of VR on pain reduction and anxiety during labour, measured by NRS score.

Conditions

Labor Pain; Virtual Reality; Analgesia; Pain

Keywords

Virtual reality; labour pain; analgesia; obstetric care

Outcome Measures

Primary Outcomes (3)

• Patients' VR experience, satisfaction and application preference regarding the guided meditation VR

  A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire. A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0). Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.

  During labour: directly after the first VR intervention (Guided meditation VR)

• Patients' VR experience, satisfaction and application preference (meditation or interactive game)

  A patients' VR experience, satisfaction and application preference was examined using a semi-structured interview. Theme's of the semi-structured interview: 1\. VR experience * General experience * VR1 experience * VR2 experience * Side effects * Reusing VR * Recommendation to other women * Improvements 2 Pain reduction * Pain intensity * Pain perception * Distraction 3 Usability VR application * VR application * Comfort of VR glasses

  5 days after labour

• Patients' VR experience, satisfaction and application preference regarding the interactive game

  A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire. A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0). Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.

  During labour: directly after the first VR intervention (Interactive game)

Secondary Outcomes (1)

• Labour pain

  4 moments during labour: Before the first VR intervention (meditation), directly after the first VR intervention (meditation). Before the second VR intervention (game), directly after the second VR intervention (game).

Study Arms (1)

Virtual reality group

EXPERIMENTAL

All participants experienced an immersive guided meditation virtual reality (VR1) and an interactive game virtual reality (VR2) experience during labour. Both VR interventions were offered for 10 minutes. Before and immediately after an intervention, the patient was asked to fill out a Numeric Rating Scale (NRS) score for pain. During the 30-minute intermission after the VR intervention the patient completed the post-intervention questionnaire. VR1 consisted of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 required women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients were allowed to stop using the VR at any moment during the intervention. Five days post-partum all participants who completed both VR interventions were contacted by telephone for an interview.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

A portable, standalone VR headset called Oculus Go (Facebook Technologies, LLC. 1601 Willow Road, Menlo Park, CA 940250) with a head-mounted display with built in audio drivers was used. Disposable hygiene masks and a surgical cap were used as an underlay below the headset an

Virtual reality group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and orally given informed consent
• years and older
• Native Dutch speaker
• Pregnant of a singleton in cephalic presentation
• Intention to deliver vaginally
• Induced labour by a balloon or artificial rupture of membranes

You may not qualify if:

• Chronic pain patients; defined as 'persistent or recurrent pain lasting longer than 3 months'. The pain is not due to the gynecological problem.
• Chronical use of pain medication (opioids)
• Alcohol or drug abuse
• Known car sickness or susceptibility to motion sickness
• Epileptic insults in previous history
• Psychotically seizures in previous history
• Claustrophobic
• Blindness
• History of mental illness
• Severe hearing or vision deficits
• Epidural Anesthesia during labour

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland MC

Heerlen, Limburg, 6401 CX, Netherlands

Location

Related Publications (1)

• Musters A, Vandevenne AS, Franx A, Wassen MMLH. Virtual Reality Experience during Labour (VIREL); a qualitative study. BMC Pregnancy Childbirth. 2023 Apr 24;23(1):283. doi: 10.1186/s12884-023-05432-9.

  PMID: 37095433 DERIVED

MeSH Terms

Conditions

Labor Pain; Agnosia; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Martine Wassen, M.D.

  Zuyderland MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Qualitative research

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 26, 2021
• Study Start: July 1, 2020
• Primary Completion: January 12, 2021
• Study Completion: March 1, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)