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Virtual Reality Relaxation for Addiction Inpatients

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: NCT04293978
Recruitment Status : Suspended (Recruitment and intervention provision paused due to COVID-19 situation. Planned to resume.)
First Posted : March 3, 2020
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
Stockholm University
Information provided by (Responsible Party):
Philip Lindner, Karolinska Institutet

Brief Summary:
This trial examines the immediate session effect of Virtual Reality (VR) relaxation, when used at an addiction inpatient ward for adolescents.

Condition or disease Intervention/treatment Phase
Addiction Behavioral: CalmPlace Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, with immediate effects of interest. Varying number of intervention uses across participants.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality Relaxation at an Adolescent Addiction Inpatient Ward: A Single-arm Pilot Trial
Actual Study Start Date : February 21, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Virtual Reality relaxation
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.
Behavioral: CalmPlace
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 Measures :
  1. Change from baseline in general well-being [ Time Frame: Change from baseline (start of session) to immediately after the intervention ]
    Rated 0-100 using a visual analogue scale with smiley-type anchors (higher score is better outcome).



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04293978


Locations
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Sweden
Maria Ungdom Heldygnsvård
Stockholm, Sweden, 18354
Sponsors and Collaborators
Karolinska Institutet
Stockholm University
Investigators
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Principal Investigator: Philip Lindner, PhD Karolinska Institutet
Publications:
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Responsible Party: Philip Lindner, Head of Research and Development, Maria Ungdom Clinic, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04293978    
Other Study ID Numbers: Virtuella Lugna rummet
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw outcome data (with no other identifiable information) may be shared with other researchers under conditions described below.
Supporting Materials: Analytic Code
Time Frame: When trial is published and up to ten years after that.
Access Criteria: Signed data sharing agreement.

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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 Philip Lindner, Karolinska Institutet:
Virtual Reality
Relaxation
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior