Comparison of Physical and Virtual Sensory Room in an Inpatient Setting

Depression Clinical Trial

Official title:

Comparison of Physical and Virtual Sensory Room in an Inpatient Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918954
• Other study ID #: VGRVR
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2020
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety State
• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• Virtual sensory room
A pair of virtual reality glasses (Oculus Go) with installed the program Calm Place, a program designed for anxiety reduction.

Other:
• Sensory room
A room with calming elements that patients can use to feel calm.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

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