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Comparison of Physical and Virtual Sensory Room in an Inpatient Setting

Primary Purpose

Anxiety State, Depression, Bipolar Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Virtual sensory room
Sensory room
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety State

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Physical sensory room

Virtual sensory room

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change on Visual Analogue Scale of anxiety
A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety

Secondary Outcome Measures

Beck´s Anxiety Scale
Total score on 21 self-rated questions on anxiety (ranging from 0=no anxiety to 63=maximum level of anxiety)
Montgomery-Åsberg Depression Rating Scale (MADRS-S)
Depression grade on a self-rating scale ranging from 0=no depression to 54=most severe depression
Use of anxiolytic medication
Use in mg of anxiolytic medication
Clinical Global Impression
Clinician assessment of patient´s overall mental state ranging from 0 (no symptoms) to 7 (severe mental illness)
Length of stay
Number of days admitted to inpatient care
Blood pressure
mmHg before and after intervention
Pulse
Heartbeats per minute before and after intervention
Visual Analogue Scale of anxiety
A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety

Full Information

First Posted
January 10, 2019
Last Updated
May 10, 2021
Sponsor
Vastra Gotaland Region
Collaborators
Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT03918954
Brief Title
Comparison of Physical and Virtual Sensory Room in an Inpatient Setting
Official Title
Comparison of Physical and Virtual Sensory Room in an Inpatient Setting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Stockholm University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study will include about 100 research subjects admitted to an inpatient ward at the department of psychiatry for affective disorder. The study will be conducted in two inpatient wards. Patients who consent to participation will be offered to stay in a sensory room (a physical sensory room in one ward and a virtual sensory room via a pair of wireless VR glasses in another ward). In connection with the use of the virtual or physical sensory room, the patients will be given a visual analogue scale which asks the patient to rate their overall anxiety and mental health on a scale from 1 (feeling very bad) to 10 (feeling excellent). This will be the primary measure of the study. Before and after each visit the participant will have their pulse and blood pressure measured. Included patients will also be asked about participation in individual interviews. Semi-structured interviews will be carried out and collected data will be analyzed with a phenomenological approach. The purpose of this study is to shed light on experiences of staying in the digital and analogue sensory rooms. A number of self-rated questionnaires will be used in the project to establish the research subjects' level of depression and anxiety during their inpatient stay. The Montgomery-Åsberg Depression Rating (MADRS-S) scale. MADRS-S is a self-assessment tool for assessing depression symptoms, it is used regularly in the clinic to evaluate depression symptoms. The inventory consists of a self-assessment form containing 9 statements intended to measure different depression symptoms. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge. Beck Anxiety Inventory (BAI) is a self-assessment instrument that measures the degree of anxiety. The inventory consists of a self-assessment form containing 21 statements intended to measure 21 different anxiety symptoms. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge. The Clinical Global Impressions (CGI) scale. CGI is a 7-scaled evaluation tool that requires the physician to determine the degree of the patient's disease at the time of assessment, in relation to the clinician's previous experience in patients with the same diagnosis. This scale is administered at the enrollment interview if patient consents to participation and once weekly until discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State, Depression, Bipolar Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical sensory room
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Virtual sensory room
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual sensory room
Intervention Description
A pair of virtual reality glasses (Oculus Go) with installed the program Calm Place, a program designed for anxiety reduction.
Intervention Type
Other
Intervention Name(s)
Sensory room
Intervention Description
A room with calming elements that patients can use to feel calm.
Primary Outcome Measure Information:
Title
Change on Visual Analogue Scale of anxiety
Description
A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety
Time Frame
Immediately before and following the first administration of treatment
Secondary Outcome Measure Information:
Title
Beck´s Anxiety Scale
Description
Total score on 21 self-rated questions on anxiety (ranging from 0=no anxiety to 63=maximum level of anxiety)
Time Frame
Once weekly from date of inclusion until the date of discharge up to 3 weeks
Title
Montgomery-Åsberg Depression Rating Scale (MADRS-S)
Description
Depression grade on a self-rating scale ranging from 0=no depression to 54=most severe depression
Time Frame
Once weekly from date of inclusion until the date of discharge up to 3 weeks
Title
Use of anxiolytic medication
Description
Use in mg of anxiolytic medication
Time Frame
Total use of medication from date of inclusion to date of discharge up to 3 weeks
Title
Clinical Global Impression
Description
Clinician assessment of patient´s overall mental state ranging from 0 (no symptoms) to 7 (severe mental illness)
Time Frame
Once weekly from date of inclusion until the date of discharge up to 3 weeks
Title
Length of stay
Description
Number of days admitted to inpatient care
Time Frame
Length of admission in days from date of inclusion to date of discharge up to a year
Title
Blood pressure
Description
mmHg before and after intervention
Time Frame
Immediately before and following first administration of treatment
Title
Pulse
Description
Heartbeats per minute before and after intervention
Time Frame
Immediately before and following first administration of treatment
Title
Visual Analogue Scale of anxiety
Description
A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety
Time Frame
An average of each immediate before and following measure of the administration of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admitted to one of the two eligible inpatient units Age over 18 years Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steinn Steingrimsson, PhD
Organizational Affiliation
Sahlgrenska Academy
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41650
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Physical and Virtual Sensory Room in an Inpatient Setting

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