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

Primary Purpose

Labor Pain, Virtual Reality, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Zuyderland Medisch Centrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Labor Pain focused on measuring Virtual reality, labour pain, analgesia, obstetric care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Written and orally given informed consent
  • 18 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Zuyderland MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual reality group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Labour pain
Labour pain before and directly after VR was evaluated using the Numeric (pain) rating scale (The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).)

Full Information

First Posted
April 11, 2021
Last Updated
April 21, 2021
Sponsor
Zuyderland Medisch Centrum
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1. Study Identification

Unique Protocol Identification Number
NCT04858984
Brief Title
Virtual Reality, Experience During Labour; a Qualitative Research (VIREL)
Acronym
VIREL
Official Title
Virtual Reality, Experience During Labour; a Qualitative Research
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zuyderland Medisch Centrum

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
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.
Detailed Description
Epidural Analgesia (EA) has been regarded as the most effective method of labour analgesia. Pharmacological analgesia methods are known to have adverse side effects, such as nausea, vomiting and drowsiness in parental opioids; pruritus, nausea, desaturation, respiratory depression and apnea in patient-controlled remifentanil analgesia; and maternal fever, maternal hypotension and urinary retention in EA. Furthermore, routine EA is likely resulting in more operative deliveries. Considering these possible adverse effects, it is worth exploring alternative methods for labour pain relief. There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain. This VIREL study aims to examine the experience, preference, and satisfaction of VR in women during labour. The study is set up as a single centre, qualitative study in a non-university teaching hospital in The Netherlands with 2800 deliveries annually. Participants will experience an immersive guided relaxation VR (VR1) and an interactive game (VR2) during labour. VR1 consists of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 requires women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients are allowed to stop using the VR at any moment during the intervention. When the participant is declared to be in labour, defined as having regular painful uterine contractions, cervical effacement and at least 3cm dilatation, VR1 will be offered for ten minutes. Before and immediately after VR1, the patient is asked to fill out a Numeric Rating Scale (NRS) score for pain. During the 30-minute intermission after VR1 the patient fills out the post-intervention questionnaire regarding VR1. Subsequently, VR2 is offered for ten minutes. Before and immediately after VR2 the patient filled in the NRS score for pain, and the patient completed a post-intervention questionnaire regarding VR2. Additional use of VR is allowed by maternal request. Five days post-partum all participants who completed both VR interventions will be contacted by telephone for a semi-structured interview.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Virtual Reality, Analgesia, Pain
Keywords
Virtual reality, labour pain, analgesia, obstetric care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Qualitative research
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
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
Primary Outcome Measure Information:
Title
Patients' VR experience, satisfaction and application preference regarding the guided meditation VR
Description
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.
Time Frame
During labour: directly after the first VR intervention (Guided meditation VR)
Title
Patients' VR experience, satisfaction and application preference (meditation or interactive game)
Description
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
Time Frame
5 days after labour
Title
Patients' VR experience, satisfaction and application preference regarding the interactive game
Description
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.
Time Frame
During labour: directly after the first VR intervention (Interactive game)
Secondary Outcome Measure Information:
Title
Labour pain
Description
Labour pain before and directly after VR was evaluated using the Numeric (pain) rating scale (The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).)
Time Frame
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).

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written and orally given informed consent 18 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Wassen, M.D.
Organizational Affiliation
Zuyderland MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuyderland MC
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6401 CX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available at the moment. The study protocol, statistical analysis plan and informed consent form will be available after publication of the article.

Learn more about this trial

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

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