Virtual Reality Relaxation for Addiction Inpatients

August 26, 2022 updated by: Philip Lindner, Karolinska Institutet

Virtual Reality Relaxation at an Adolescent Addiction Inpatient Ward: A Single-arm Pilot Trial

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18354
        • Maria Ungdom Heldygnsvård

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline (start of session) to immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Stockholm University

Investigators

  • Principal Investigator: Philip Lindner, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Virtuella Lugna rummet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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