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Completed

NCT Number: NCT03918954

Comparison of Physical and Virtual Sensory Room in an Inpatient Setting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 41650, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual sensory room

Device

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

Sensory room

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Stockholm University

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2019
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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