NCT05478941: VRelax

Can Virtual Reality Improve the Progressive Muscular Relaxation Technique Efficacy?

Completed NA Last updated 29 November 2023

What this trial tests

NA trial testing Progressive Muscular Relaxation via Zoom, and Exposure to a Virtual Reality scenarios deployed by an Head mounted tool (Oculus Quest 2). in Anxiety in 150 participants. Completed in 24 July 2023.

Timeline

8 February 2022

Primary endpoint
24 July 2023

24 July 2023

Quick facts

Lead sponsor	University of Padova
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	8 February 2022
Primary completion	24 July 2023
Estimated completion	24 July 2023
Sites	1 location across Italy

Drugs / interventions tested

• Progressive Muscular Relaxation via Zoom, and Exposure to a Virtual Reality scenarios deployed by an Head mounted tool (Oculus Quest 2).
• Progressive Muscular Relaxation via Audio-track, and Exposure to a Virtual Reality scenarios deployed by an Head mounted tool (Oculus Quest 2).
• Progressive Muscular Relaxation via Zoom, and Exposure to a Guided Imagery Exposure.

Conditions studied

• Anxiety — all drugs for Anxiety →
• Coping Skills — all drugs for Coping Skills →
• Depression — all drugs for Depression →
• Stress, Emotional — all drugs for Stress, Emotional →

Sponsor

University of Padova

Who can join

18 and older, any sex, with Anxiety or Coping Skills. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purposes of the current research project are as follows:

1. investigate if the PMRT associated with a personalized-relaxing scenario in VR can facilitate the recalling of the relaxing image in the real world than the standard procedure (consisting of PMRT associated with the in-imagination exposure to a comfortable subjective context). The investigators assume that VR would be more efficient than in-imagination since it would make easy the visualization process favor people cope with more realistic sensory experiences than in-imagination exposure. Accordingly, the VR exposure would elicit the strongest association between the relaxation procedure (neutral stimulus, NS) and the relaxing context in VR (conditioning stimulus, CS);
2. whether exposure to a personalized VREs has a more significant impact on anxiety, depression, stress, sense of presence, and quality of psychological well-being; these constructs are investigated by comparing the participants' performance on self-report questionnaires (described in the next section), before the start of the training (T0; baseline), at the end of all the four relaxing sessions, one week after the end of relaxation sessions (T1; day 7), and during follow up (T2; day 14);
3. if the relaxing sessions administered via Zoom are more proper for managing anxiety and stress than a procedure learned via an audio registration.

Considering the ability to generate vivid visual images is positively associated with the capacity to feel present in a virtual world, all the participants are asked to fulfill two questionnaires before the VR or the Guided Imagery exposure to investigate the vividness and the capacity to control mental images respectively, and to control the impact of these two dependent variables on the sense of presence self-reported after the in imagination or VR exposure.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Personalized Virtual Reality Compared With Guided Imagery for Enhancing the Impact of Progressive Muscle Relaxation Training: Pilot Randomized Controlled Trial.
   Pardini S, Gabrielli S, Olivetto S, Fusina F, et al · · 2024 · cited 12× · PMID 38289673 · DOI 10.2196/48649
2. Personalized, Naturalistic Virtual Reality Scenarios Coupled With Web-Based Progressive Muscle Relaxation Training for the General Population: Protocol for a Proof-of-Principle Randomized Controlled Trial.
   Pardini S, Gabrielli S, Olivetto S, Fusina F, et al · · 2023 · cited 7× · PMID 37067881 · DOI 10.2196/44183