Virtual Reality Experiences as Tools to Support Mental Health in Parents of Children With Autism

NCT05852795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-05-10

No results posted yet for this study

Summary

Mindfulness is a technique that involves the intentional and non-judgmental regulation of attention to the present moment, with curiosity, openness, and acceptance, as per its definition. Mindfulness-based interventions (MBIs) have been used to manage mood disorders in various clinical and non-clinical settings, including neurological patients and cardiovascular diseases. Studies have consistently demonstrated that MBIs reduce depressive and anxiety symptoms, as well as rumination. MBIs are considered an alternative and effective treatment for reducing psychological stress in the management of different health conditions. Virtual reality (VR) has recently been proposed as an intermediate interface to help patients with emotional dysregulation learn mindfulness practices.

Within this context, new approaches to mental health integrating advanced technologies such as VR can play a critical role. In this interventional study we will seek to demonstrate the effectiveness of a virtual reality-mediated mindfulness-based intervention in a particular group of people who are constantly experiencing psychological distress due to caring for children with autism spectrum disorders (ASD).

Conditions

Interventions

OTHER

Virtual Reality-mediated Mindfulness-Based Interventions

The Experimental will undergo 8 weekly sessions of immersive experience lasting 30 minutes. Each session is divided as follows: * First phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). * Second phase: Detection of physiological parameters with Oculus instrumentation turned ON during mindfulness experience (10 minutes * Third phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). This intervention will produce a multisensory experience merging visual and digital auditory stimuli. The audio recording also included some ambient natural sound effects, to make the practice more immersive.

OTHER

Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience

The Control will undergo 8 weekly sessions of immersive experience lasting 30 minutes. Each session is divided as follows: * First phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). * Second phase: Detection of physiological parameters with Oculus instrumentation turned ON during mindfulness experience (10 minutes * Third phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). This intervention will produce a monosensorial experience with video guided stimulation of naturalistic scenarios.

Sponsors & Collaborators

  • Istituto per la Ricerca e l'Innovazione Biomedica

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-04-01
Completion
2023-04-15

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852795 on ClinicalTrials.gov