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

NCT ID: NCT05852795

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-04-15

Brief 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).

Detailed Description

In this study participants will be randomly assigned to an experimental or control groups according to the main treatment. Participants in the experimental group will undergo 8 VR sessions by observing a scenario accompanied by a voice audio guide, whereas participants in the control group will complete the 8 VR sessions by observing scenery accompanied only by the sounds of nature. All groups will be treated one time a week for 1h sessions for 8 consecutive weeks.

Participant recruitment: The families of children with ASD will be recruited at the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina as part of an ongoing research program.

Allocation of the sample: Eligible participants who will meet the inclusion criteria will receive written information about the procedure and be asked to sign the consent form indicating their willingness to participate in the study. Only qualified individuals who provided informed consent will be randomly assigned to the experimental or control group in a 1:1 manner. Participants will then receive information regarding the allocation result. The randomization will be performed using a computer-generated, site-stratified, randomization schedule. Randomization will be stratified according to age, sex and educational level. For each stratum, random numbers will be assigned to the participants and put into envelopes; it will be determined randomly whether the even or odd number would enter the experimental group. Participants will be assigned to the study according to the numbers they received on opening the envelopes.

Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the study protocol, and (4) other circumstances that would endanger the health of the subject if he/she would to continue his/her participation in the trial.

Immersive virtual environments: Virtual reality experience will be made by using 8 relaxing virtual scenarios (e.g., naturalistic environments) created by BECOME s.r.l. (https://www.discoverbecome.com). The virtual experiences will be offered through the Oculus Quest 2 (marketed since November 2021 as Meta Quest 2)

Sample size: Power size calculation will be performed with GPower 3.1. Considering an anticipated effect size (f) of 1, an alpha set at 0.05, 2 groups, and a 0.95 statistical power, the total sample size required is N = 46.

Conditions

Autism Spectrum Disorder; Parents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental group

VR-based and audio-based mindfulness experience. Partecipants watch VR scenario and receive a guided mindfulness practice.

Group Type: EXPERIMENTAL

Virtual Reality-mediated Mindfulness-Based Interventions

Intervention Type: OTHER

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.

Control Group

VR-based mindfulness experience. Participants watch VR scenario without experiencing voice guided mindfulness practice.

Group Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• being parent of a child diagnosed with autism
• absence of pharmacotherapy that could interfere with the measured data (psychoactive drugs, anti-hypertensive, anti-depressants)
• no significant visual impairment

Exclusion Criteria

• history of psychiatric diagnosis
• presence of medical disorders (heart disease or blood pressure, neurological disorders, epilepsy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Antonio Cerasa

Head of Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Cerasa

Role: PRINCIPAL_INVESTIGATOR

antonio.cerasa@irib.cnr.it

Locations

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, , Italy

Countries

Italy

References

Failla C, Marino F, Bernardelli L, Gaggioli A, Doria G, Chila P, Minutoli R, Mangano R, Torrisi R, Tartarisco G, Bruschetta R, Arcuri F, Cerasa A, Pioggia G. Mediating Mindfulness-Based Interventions with Virtual Reality in Non-Clinical Populations: The State-of-the-Art. Healthcare (Basel). 2022 Jun 29;10(7):1220. doi: 10.3390/healthcare10071220.

Reference Type: BACKGROUND

PMID: 35885747 (View on PubMed)

Puglisi A, Capri T, Pignolo L, Gismondo S, Chila P, Minutoli R, Marino F, Failla C, Arnao AA, Tartarisco G, Cerasa A, Pioggia G. Social Humanoid Robots for Children with Autism Spectrum Disorders: A Review of Modalities, Indications, and Pitfalls. Children (Basel). 2022 Jun 25;9(7):953. doi: 10.3390/children9070953.

Reference Type: BACKGROUND

PMID: 35883937 (View on PubMed)

Marino F, Failla C, Carrozza C, Ciminata M, Chila P, Minutoli R, Genovese S, Puglisi A, Arnao AA, Tartarisco G, Corpina F, Gangemi S, Ruta L, Cerasa A, Vagni D, Pioggia G. Mindfulness-Based Interventions for Physical and Psychological Wellbeing in Cardiovascular Diseases: A Systematic Review and Meta-Analysis. Brain Sci. 2021 May 29;11(6):727. doi: 10.3390/brainsci11060727.

Reference Type: BACKGROUND

PMID: 34072605 (View on PubMed)

Other Identifiers

CNR-IRIB-PRO-2023-001

Identifier Type: -

Identifier Source: org_study_id