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FLOAT Through Anxiety: Virtual Reality Application's Efficacy as a Tool to Distract From Negative Emotions and Thoughts

FLOAT Through Anxiety: Examining the Efficacy and Safety of the Virtual Reality Application Float as a Tool to Distract From Negative Emotions and Thoughts in People With High Levels of Anxiety and Stress

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06197464
Enrollment
62
Registered
2024-01-09
Start date
2023-03-12
Completion date
2024-01-20
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Control, Experimental

Brief summary

The goal of this clinical trial is to examine the effectiveness and safety of the VR FLOAT application as a tool to reduce negative thoughts and feelings and anxiety symptoms in students with high levels of stress and anxiety. The main questions it aims to answer are: 1. Will subjects with high levels of anxiety who will use the FLOAT application experience a more significant relief in feelings of anxiety compared to subjects in the control group? 2. Will subjects who are used to using technology find greater comfort in using VR compared to subjects who are not used to it? 3. What is the degree of satisfaction with the use of VR and are there any reports of side effects?Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets Researchers will compare control group to see The comparison between using FLOAT as a regulation strategy after psychoeducation on emotional regulation and cognitive-behavioral use of a regulation strategy after the same psychoeducation

Interventions

BEHAVIORALpsychoeducation on emotional regulation and distraction strategy

The experimenter gives the subject psychoeducation about emotional regulation and distraction strategy with the help of a conversation and a presentation.

DEVICEUsing the FLOAT app on a virtual reality device

The subject should wear the VR device, and use the FLOAT application.

BEHAVIORALpsychoeducation on emotional regulation and distraction strategy + Application

psychoeducation on emotional regulation and distraction strategy + Application

Sponsors

University of Haifa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 'moderate' or 'severe' levels of stress and/or anxiety according to the DASS-21 questionnaire * student

Exclusion criteria

* under the age of 18 * diagnoses of schizophrenia or bipolar disorder, including past or present psychotic conditions * suicidality * pregnant women * do not speak or read Hebrew fluently * a diagnosis of epilepsy.

Design outcomes

Primary

MeasureTime frameDescription
situational anxiety before sessiona weekThe State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety
situational anxiety after sessiona weekThe State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety
satisfaction with lifebaselineSatisfaction with Life Scale (SWLS). 5 to 35. A high score represents higher life satisfaction and a lower score represents a lower life satisfaction
Ease of using the technologyweek 3, after interventionSystem Usability Scale (SUS). scale from 0 to 100. A score higher than 70 indicates good usability, while a score lower than 50 indicates low usability.

Secondary

MeasureTime frameDescription
The FLOAT user experienceweek 3, after interventionA semi-structured interview, will be analyzed qualitatively

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026