NCT04293978

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

February 21, 2020

Last Update Submit

August 26, 2022

Conditions

Addiction

Keywords

Virtual RealityRelaxation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Virtual Reality relaxation

EXPERIMENTAL

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

Interventions

CalmPlaceBEHAVIORAL

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.

Virtual Reality relaxation

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at Maria Ungdom inpatient ward.
  • Sufficient grasp of Swedish to understand terms of study participation and intervention instructions.

You may not qualify if:

  • Self-reported stereoscopic vision or balance problems hindering VR experience.
  • Self-reported history of repeated violent outbursts when using technology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Ungdom Heldygnsvård

Stockholm, 18354, Sweden

Location

Related 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.

    PMID: 30778311BACKGROUND

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Philip Lindner, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm, with immediate effects of interest. Varying number of intervention uses across participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Development, Maria Ungdom Clinic

Study Record Dates

First Submitted

February 21, 2020

First Posted

March 3, 2020

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Raw outcome data (with no other identifiable information) may be shared with other researchers under conditions described below.

Shared Documents
ANALYTIC CODE
Time Frame
When trial is published and up to ten years after that.
Access Criteria
Signed data sharing agreement.

Locations

SE(1)