Back to resultsVirtual Reality Relaxation for Addiction Inpatients
Primary Purpose
Addiction
Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CalmPlace
Sponsored by
About this trial
This is an interventional treatment trial for Addiction focused on measuring Virtual Reality, Relaxation
Eligibility Criteria
Inclusion Criteria:
- Patient at Maria Ungdom inpatient ward.
- Sufficient grasp of Swedish to understand terms of study participation and intervention instructions.
Exclusion Criteria:
- Self-reported stereoscopic vision or balance problems hindering VR experience.
- Self-reported history of repeated violent outbursts when using technology.
Sites / Locations
- Maria Ungdom Heldygnsvård
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Reality relaxation
Arm Description
Participants may request to use the application at any time during their stay at the ward, as many times as they wish. Participants sign in using an anonymous study ID and sessions (and outcomes) are automatically logged by the device to this ID.
Outcomes
Primary Outcome Measures
Change from baseline in general well-being
Rated 0-100 using a visual analogue scale with smiley-type anchors (higher score is better outcome).
Secondary Outcome Measures
Full Information
NCT ID
NCT04293978
First Posted
February 21, 2020
Last Updated
August 26, 2022
Sponsor
Karolinska Institutet
Collaborators
Stockholm University
1. Study Identification
Unique Protocol Identification Number
NCT04293978
Brief Title
Virtual Reality Relaxation for Addiction Inpatients
Official Title
Virtual Reality Relaxation at an Adolescent Addiction Inpatient Ward: A Single-arm Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Suspended
Why Stopped
Recruitment and intervention provision paused due to COVID-19 situation. Planned to resume.
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm University
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 trial examines the immediate session effect of Virtual Reality (VR) relaxation, when used at an addiction inpatient ward for adolescents.
Detailed Description
Past research has revealed that Virtual Reality nature environments can be used to induce relaxation, yet this type of intervention has not yet been evaluated in a clinical setting. This trial examines whether VR relaxation can be used as a digital equivalent of a (physical) comfort room at an an addiction inpatient ward for adolescents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
Virtual Reality, Relaxation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, with immediate effects of interest. Varying number of intervention uses across participants.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality relaxation
Arm Type
Experimental
Arm Description
Participants may request to use the application at any time during their stay at the ward, as many times as they wish. Participants sign in using an anonymous study ID and sessions (and outcomes) are automatically logged by the device to this ID.
Intervention Type
Behavioral
Intervention Name(s)
CalmPlace
Intervention Description
Self-contained VR application allowing the user to build and custom a relaxation session, with options to vary session length (9-20 minutes), music/sound, relaxation exercises, and specific nature environment (three available) including time of day and events (e.g. rain). Delivered using an Oculus Go devices in kiosk-mode.
Primary Outcome Measure Information:
Title
Change from baseline in general well-being
Description
Rated 0-100 using a visual analogue scale with smiley-type anchors (higher score is better outcome).
Time Frame
Change from baseline (start of session) to immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient at Maria Ungdom inpatient ward.
Sufficient grasp of Swedish to understand terms of study participation and intervention instructions.
Exclusion Criteria:
Self-reported stereoscopic vision or balance problems hindering VR experience.
Self-reported history of repeated violent outbursts when using technology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Lindner, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Ungdom Heldygnsvård
City
Stockholm
ZIP/Postal Code
18354
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw outcome data (with no other identifiable information) may be shared with other researchers under conditions described below.
IPD Sharing Time Frame
When trial is published and up to ten years after that.
IPD Sharing Access Criteria
Signed data sharing agreement.
Citations:
PubMed Identifier
30778311
Citation
Lindner P, Miloff A, Hamilton W, Carlbring P. The Potential of Consumer-Targeted Virtual Reality Relaxation Applications: Descriptive Usage, Uptake and Application Performance Statistics for a First-Generation Application. Front Psychol. 2019 Feb 4;10:132. doi: 10.3389/fpsyg.2019.00132. eCollection 2019.
Results Reference
background
Learn more about this trial
Virtual Reality Relaxation for Addiction Inpatients
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