Virtual Reality Relaxation for Addiction Inpatients

Sponsor

Karolinska Institutet (Other)

Overall Status

Suspended

CT.gov ID

NCT04293978

Collaborator

Stockholm University (Other)

Enrollment

Location

Arm

22.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Addiction	Behavioral: CalmPlace	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Feb 21, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in general well-being [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maria Ungdom Heldygnsvård	Stockholm		Sweden	18354

Sponsors and Collaborators

Karolinska Institutet
Stockholm University

Investigators

Principal Investigator: Philip Lindner, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

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:

Mar 3, 2020

Last Update Posted:

Feb 18, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Philip Lindner, Head of Research and Development, Maria Ungdom Clinic, Karolinska Institutet

Virtual Reality

Relaxation

Additional relevant MeSH terms:

Behavior, Addictive

Study Results

No Results Posted as of Feb 18, 2021