Comparison of Physical and Virtual Sensory Room in an Inpatient Setting

NCT03918954 | Completed

• 1 other identifier: VGRVR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sensory room is a new method in psychiatric inpatient care for management of anxiety. Since this method for anxiety management is being implemented more and more extensively within the psychiatric care system it is important to study its effect and whether there is any difference between physical and virtual sensory. In this study, the effect on mental well-being, pulse and blood pressure will be compared before and after each use of a virtual or physically sensory room. How the different methods affect the total care time, use of anxiety medication and results from self-assessment scales to measure depression and anxiety symptoms will also be looked at. The study will be conducted on two separate wards which primarily care for patients with the primary diagnosis of bipolar disorder.

Conditions

Anxiety State; Depression; Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Change on Visual Analogue Scale of anxiety

  A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety

  Immediately before and following the first administration of treatment

Secondary Outcomes (8)

• Beck´s Anxiety Scale

  Once weekly from date of inclusion until the date of discharge up to 3 weeks

• Montgomery-Åsberg Depression Rating Scale (MADRS-S)

  Once weekly from date of inclusion until the date of discharge up to 3 weeks

• Use of anxiolytic medication

  Total use of medication from date of inclusion to date of discharge up to 3 weeks

• Clinical Global Impression

  Once weekly from date of inclusion until the date of discharge up to 3 weeks

• Length of stay

  Length of admission in days from date of inclusion to date of discharge up to a year

Study Arms (2)

Physical sensory room

ACTIVE COMPARATOR

In the inpatient ward there is a specifically designed room for calming down which a patient can request access to. In the room there is calming music, soft mats, nature themed wallpaper and calming visual lighting.

Other: Sensory room

Virtual sensory room

EXPERIMENTAL

The patients will have access to wireless virtual reality glasses during a session. The glasses will have a specially made protection that will be disinfected between each user, all users will also have the opportunity to choose a disposable cover for the glasses. The VR glasses are adjustable and adaptable to all types of head sizes and can be used with regular glasses. The application accessable in the VR glasses is called Calm Place, a virtual natural environment with day and night cycles, dynamic weather and associated soundscapes.

Device: Virtual sensory room

Interventions

Virtual sensory room DEVICE

A pair of virtual reality glasses (Oculus Go) with installed the program Calm Place, a program designed for anxiety reduction.

Virtual sensory room

Sensory room OTHER

A room with calming elements that patients can use to feel calm.

Physical sensory room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to one of the two eligible inpatient units
• Age over 18 years

You may not qualify if:

• Diagnosis of schizophrenia (ICD-10 F20) or schizoaffective disorder (ICD-10 F25)
• Intellectual developmental disorder, organic brain injury or other condition that precludes informed consent
• Active withdrawal symptoms from alcohol or other substances of abuse
• Visual or balance disorder

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Stockholm University: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41650, Sweden

Location

Related Publications (1)

• Ilioudi M, Lindner P, Ali L, Wallstrom S, Thunstrom AO, Ioannou M, Anving N, Johansson V, Hamilton W, Falk O, Steingrimsson S. Physical Versus Virtual Reality-Based Calm Rooms for Psychiatric Inpatients: Quasi-Randomized Trial. J Med Internet Res. 2023 May 19;25:e42365. doi: 10.2196/42365.

  PMID: 37204858 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Bipolar Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Steinn Steingrimsson, PhD

  Sahlgrenska Academy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: April 18, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)