Comparison of Physical and Virtual Sensory Room in an Inpatient Setting

• ClinicalTrials.gov Identifier: NCT03918954
• Recruitment Status: Completed
• First Posted: April 18, 2019
• Last Update Posted: May 13, 2021
• Sponsor: Vastra Gotaland Region
• Collaborator: Stockholm University
• Information provided by (Responsible Party): Vastra Gotaland Region

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.

Condition or disease	Intervention/treatment	Phase
Anxiety State; Depression; Bipolar Depression	Device: Virtual sensory room; Other: Sensory room	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Comparison of Physical and Virtual Sensory Room in an Inpatient Setting
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: May 1, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Physical sensory room; 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; A room with calming elements that patients can use to feel calm.
Experimental: Virtual sensory room; 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; A pair of virtual reality glasses (Oculus Go) with installed the program Calm Place, a program designed for anxiety reduction.

Outcome Measures

Primary Outcome Measures :

1. Change on Visual Analogue Scale of anxiety [ Time Frame: Immediately before and following the first administration of treatment ]
   A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety

Secondary Outcome Measures :

1. Beck´s Anxiety Scale [ Time Frame: Once weekly from date of inclusion until the date of discharge up to 3 weeks ]
   Total score on 21 self-rated questions on anxiety (ranging from 0=no anxiety to 63=maximum level of anxiety)
2. Montgomery-Åsberg Depression Rating Scale (MADRS-S) [ Time Frame: Once weekly from date of inclusion until the date of discharge up to 3 weeks ]
   Depression grade on a self-rating scale ranging from 0=no depression to 54=most severe depression
3. Use of anxiolytic medication [ Time Frame: Total use of medication from date of inclusion to date of discharge up to 3 weeks ]
   Use in mg of anxiolytic medication
4. Clinical Global Impression [ Time Frame: Once weekly from date of inclusion until the date of discharge up to 3 weeks ]
   Clinician assessment of patient´s overall mental state ranging from 0 (no symptoms) to 7 (severe mental illness)
5. Length of stay [ Time Frame: Length of admission in days from date of inclusion to date of discharge up to a year ]
   Number of days admitted to inpatient care
6. Blood pressure [ Time Frame: Immediately before and following first administration of treatment ]
   mmHg before and after intervention
7. Pulse [ Time Frame: Immediately before and following first administration of treatment ]
   Heartbeats per minute before and after intervention
8. Visual Analogue Scale of anxiety [ Time Frame: An average of each immediate before and following measure of the administration of treatment ]
   A visual analogue scale from 0 (lowest) to 10 (highest) level of anxiety

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden, 41650

Sponsors and Collaborators

Vastra Gotaland Region

Stockholm University

Investigators

• Study Director: Steinn Steingrimsson, PhD; Sahlgrenska Academy

More Information

• Responsible Party: Vastra Gotaland Region
• ClinicalTrials.gov Identifier: NCT03918954
• Other Study ID Numbers: VGRVR
• First Posted: April 18, 2019
• Last Update Posted: May 13, 2021
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Bipolar Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Bipolar and Related Disorders