Clinical trial NCT03918954: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Depression
Bipolar Depression
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Stockholm University
First posted: 2019-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change on Visual Analogue Scale of anxiety
timeFrame: Immediately before and following the first administration of treatment
Secondary outcomes:
measure: Beck´s Anxiety Scale
timeFrame: Once weekly from date of inclusion until the date of discharge up to 3 weeks
measure: Montgomery-Åsberg Depression Rating Scale (MADRS-S)
timeFrame: Once weekly from date of inclusion until the date of discharge up to 3 weeks
measure: Use of anxiolytic medication
timeFrame: Total use of medication from date of inclusion to date of discharge up to 3 weeks
measure: Clinical Global Impression
timeFrame: Once weekly from date of inclusion until the date of discharge up to 3 weeks
measure: Length of stay
timeFrame: Length of admission in days from date of inclusion to date of discharge up to a year
measure: Blood pressure
timeFrame: Immediately before and following first administration of treatment
measure: Pulse
timeFrame: Immediately before and following first administration of treatment
measure: Visual Analogue Scale of anxiety
timeFrame: An average of each immediate before and following measure of the administration of treatment
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy
name: Steinn Steingrimsson, PhD
role: STUDY_DIRECTOR
References: