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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04293978
Other study ID # Virtuella Lugna rummet
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Suspended
Enrollment 40
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden Maria Ungdom Heldygnsvård Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Stockholm University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in general well-being 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
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