Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852795
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2023-04-24
Brief Title:
Virtual Reality Experiences as Tools to Support Mental Health in Parents of Children With Autism
Sponsor:
Istituto per la Ricerca e lInnovazione Biomedica
Organization:
Istituto per la Ricerca e lInnovazione Biomedica
Study Overview
Official Title:
Evaluating the Behavioral Effect of a Virtual Reality-mediated Mindfulness-based Interventions on Parents of Children With Autism a Randomized Controlled Trial RCT Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mind-VR
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
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 11 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 heshe would to continue hisher participation in the trial
Immersive virtual environments Virtual reality experience will be made by using 8 relaxing virtual scenarios eg naturalistic environments created by BECOME srl httpswwwdiscoverbecomecom 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 31 Considering an anticipated effect size f of 1 an alpha set at 005 2 groups and a 095 statistical power the total sample size required is N 46
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 11 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 heshe would to continue hisher participation in the trial
Immersive virtual environments Virtual reality experience will be made by using 8 relaxing virtual scenarios eg naturalistic environments created by BECOME srl httpswwwdiscoverbecomecom 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 31 Considering an anticipated effect size f of 1 an alpha set at 005 2 groups and a 095 statistical power the total sample size required is N 46
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None