Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05478941
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2022-07-16
Brief Title:
Can Virtual Reality Improve the Progressive Muscular Relaxation Technique Efficacy
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Can Virtual Reality Improve the Progressive Muscular Relaxation Technique Efficacy
Status:
COMPLETED
Status Verified Date:
2023-11
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:
VRelax
Brief Summary:
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
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
Detailed Description:
Each participant is randomly assigned to one of the three following different conditions
1 Progressive Muscle Relaxation training via Zoom and Guided Imagery exposure A standardized protocol regarding the information on the training background is shared with participants
Then they are invited to participate in four individually PMRT sessions two sessions per week deployed via Zoom
The fifth session T1 day 7 is administered in-presence at the Virtual Reality Laboratory A10-A11 - University of Padova here an in-imagination relaxing scenario is built up with the support of the Psychotherapist then participants are exposed to an in-vivo-PMRT-relaxing session conducted by the Psychotherapist with the request to think about the in-imagination relaxing scenario created before during the progressive relaxation procedure
In the follow-up phase T2 day 14 the therapist asks to recover the in-imagination relaxing scenario and relax giving participants the same time allowed for the last guided relaxing session
2 Progressive Muscle Relaxation training via Zoom and personalized VR exposure PMRT sessions and expected time length are the same as for the first group Differences regard the fifth session where the relaxing scenario is built with the psychotherapist support based on the VRs tools Indeed during the in-presence session participants are exposed to a merged personalized and natural VR scenario and PMRT session administered by the Oculus Quest 2 tool
During the follow-up T2 day 14 it is asked to recover the image and relax making it available at the same time allowed for the last guided session
3 Progressive Muscle Relaxation training based on audio-recording and personalized VR exposure In this condition a standardized protocol of information and the four PMRT sessions are administered individually based on an audio track through the Moodle e-learning platform of the University of Padova
During the fifth session T1 day 7 users are asked to participate in an in-presence session in which they are exposed to a merged personalized relaxing VR scenario and a PMRT session administered based on the Oculus Quest 2 tool The last follow-up session has the same features as the other groups
Assessment phases and Experimental procedure
T0 baseline before the PMRT sessions 37 minutes
The T0 assessment is the same for all participants and is administered at the Virtual Reality Laboratory A10-A11- Department of General Psychology University of Padua It implies the administration of the following measures
a demographic schedule addressing age gender nationality mother-tongue marital status years of school attendance employment status psychological problemsdisorders drugs use medical conditions neuromuscular issues previous injures previous experiences in relaxation practice or anxiety management training or with Oculus
a series of self-report questionnaires investigating depression anxiety stress quality of life and distress coping strategies State Trait Anxiety Inventory-Y STAI-Y Depression Anxiety Stress Scales-21 DASS-21 Psychological General Well-Being Index PGWBI Coping Orientation to the Problems Experienced-Nuova Versione Italiana COPE-NVI
resting heart rate detection with MiBand 2
Before and after the four relaxing sessions administered remotely 20 minutes globally
Before and after each relaxation session the personal level of tension is assessed using a 0 no tension to 10 extreme tension level scale moreover the state-anxiety level is evaluated based on the STAI-Y1
The four-relaxation sessions are administered 2-3 days apart from each other for all three groups The assessment phase is administered online based on the Moodle e-learning platform University of Padova
T1 phase day 7 approximately 60 minutes Before and after each relaxation session subjects of tension and anxiety are assessed using a 0 no tension to 10 extreme tension level scale and the state-anxiety level is evaluated based on the STAI-Y1
Then participants have been exposed to a PMRT session merged with a VR or a Guided Imagery procedure
Before the in-imagination or the VR experience all the participants fill out the Vividness of Visual Imagery Questionnaire VVIQ and the Test of Visual Imagery Control TVIC After the PMRT session users compile a series of self-report questionnaires investigating depression anxiety stress and quality of life STAI-Y DASS-21 PGWBI and the VR group only fills out the VRSQ to monitor VR-related side effects eg sickness and headache and the ITC-Sense of Presence Inventory to assess the sense of presence at the end of T1 phase
The MiBand 2 was used during the entire T1 phase administration to detect the resting heart rate activity
This assessment phase is administered based on the Moodle e-learning platform
T2 follow up day 14 approximately 45 minutes Before and after each relaxation session subjects of tension and anxiety are assessed using a 0 no tension to 10 extreme tension level scale and the state-anxiety level is evaluated based on the STAI-Y1
All the users were exposed to a self-guided imagery experience in which those who were part of the VR group were asked to recall the personalized VR scenario experienced during the T1 phase day 7 Instead the Guided Imagery group retrieved the image participants had used in association with the PMRT during the T1 phase day 7
After the session participants compile a series of self-report questionnaires investigating depression anxiety stress quality of life STAI-Y DASS-21 PGWBI and an ad hoc version based on the ITC-Sense of Presence Inventory to assess the sense of presence experienced during the imagery experience
This assessment phase is administered based on the Moodle e-learning platform
The follow-up assessment procedure requires approximately 25 minutes and is based on
-a series of self-report questionnaires investigating depression anxiety stress and quality of life STAI-Y DASS-21 PGWBI
The MiBand 2 was used during the entire T1 phase administration day 7 to detect the resting heart rate activity
In general the risks identified are principally related to difficulties in the technical implementation in this context mitigations strategies are represented by the feasibility study conducted in 2021 which helped obtain information for improving the VR environments according to users needs and preferences Effective recruitment strategies are deployed in the Trentino and Veneto regions to cope with the possible risk of drop-out of participants
1 Progressive Muscle Relaxation training via Zoom and Guided Imagery exposure A standardized protocol regarding the information on the training background is shared with participants
Then they are invited to participate in four individually PMRT sessions two sessions per week deployed via Zoom
The fifth session T1 day 7 is administered in-presence at the Virtual Reality Laboratory A10-A11 - University of Padova here an in-imagination relaxing scenario is built up with the support of the Psychotherapist then participants are exposed to an in-vivo-PMRT-relaxing session conducted by the Psychotherapist with the request to think about the in-imagination relaxing scenario created before during the progressive relaxation procedure
In the follow-up phase T2 day 14 the therapist asks to recover the in-imagination relaxing scenario and relax giving participants the same time allowed for the last guided relaxing session
2 Progressive Muscle Relaxation training via Zoom and personalized VR exposure PMRT sessions and expected time length are the same as for the first group Differences regard the fifth session where the relaxing scenario is built with the psychotherapist support based on the VRs tools Indeed during the in-presence session participants are exposed to a merged personalized and natural VR scenario and PMRT session administered by the Oculus Quest 2 tool
During the follow-up T2 day 14 it is asked to recover the image and relax making it available at the same time allowed for the last guided session
3 Progressive Muscle Relaxation training based on audio-recording and personalized VR exposure In this condition a standardized protocol of information and the four PMRT sessions are administered individually based on an audio track through the Moodle e-learning platform of the University of Padova
During the fifth session T1 day 7 users are asked to participate in an in-presence session in which they are exposed to a merged personalized relaxing VR scenario and a PMRT session administered based on the Oculus Quest 2 tool The last follow-up session has the same features as the other groups
Assessment phases and Experimental procedure
T0 baseline before the PMRT sessions 37 minutes
The T0 assessment is the same for all participants and is administered at the Virtual Reality Laboratory A10-A11- Department of General Psychology University of Padua It implies the administration of the following measures
a demographic schedule addressing age gender nationality mother-tongue marital status years of school attendance employment status psychological problemsdisorders drugs use medical conditions neuromuscular issues previous injures previous experiences in relaxation practice or anxiety management training or with Oculus
a series of self-report questionnaires investigating depression anxiety stress quality of life and distress coping strategies State Trait Anxiety Inventory-Y STAI-Y Depression Anxiety Stress Scales-21 DASS-21 Psychological General Well-Being Index PGWBI Coping Orientation to the Problems Experienced-Nuova Versione Italiana COPE-NVI
resting heart rate detection with MiBand 2
Before and after the four relaxing sessions administered remotely 20 minutes globally
Before and after each relaxation session the personal level of tension is assessed using a 0 no tension to 10 extreme tension level scale moreover the state-anxiety level is evaluated based on the STAI-Y1
The four-relaxation sessions are administered 2-3 days apart from each other for all three groups The assessment phase is administered online based on the Moodle e-learning platform University of Padova
T1 phase day 7 approximately 60 minutes Before and after each relaxation session subjects of tension and anxiety are assessed using a 0 no tension to 10 extreme tension level scale and the state-anxiety level is evaluated based on the STAI-Y1
Then participants have been exposed to a PMRT session merged with a VR or a Guided Imagery procedure
Before the in-imagination or the VR experience all the participants fill out the Vividness of Visual Imagery Questionnaire VVIQ and the Test of Visual Imagery Control TVIC After the PMRT session users compile a series of self-report questionnaires investigating depression anxiety stress and quality of life STAI-Y DASS-21 PGWBI and the VR group only fills out the VRSQ to monitor VR-related side effects eg sickness and headache and the ITC-Sense of Presence Inventory to assess the sense of presence at the end of T1 phase
The MiBand 2 was used during the entire T1 phase administration to detect the resting heart rate activity
This assessment phase is administered based on the Moodle e-learning platform
T2 follow up day 14 approximately 45 minutes Before and after each relaxation session subjects of tension and anxiety are assessed using a 0 no tension to 10 extreme tension level scale and the state-anxiety level is evaluated based on the STAI-Y1
All the users were exposed to a self-guided imagery experience in which those who were part of the VR group were asked to recall the personalized VR scenario experienced during the T1 phase day 7 Instead the Guided Imagery group retrieved the image participants had used in association with the PMRT during the T1 phase day 7
After the session participants compile a series of self-report questionnaires investigating depression anxiety stress quality of life STAI-Y DASS-21 PGWBI and an ad hoc version based on the ITC-Sense of Presence Inventory to assess the sense of presence experienced during the imagery experience
This assessment phase is administered based on the Moodle e-learning platform
The follow-up assessment procedure requires approximately 25 minutes and is based on
-a series of self-report questionnaires investigating depression anxiety stress and quality of life STAI-Y DASS-21 PGWBI
The MiBand 2 was used during the entire T1 phase administration day 7 to detect the resting heart rate activity
In general the risks identified are principally related to difficulties in the technical implementation in this context mitigations strategies are represented by the feasibility study conducted in 2021 which helped obtain information for improving the VR environments according to users needs and preferences Effective recruitment strategies are deployed in the Trentino and Veneto regions to cope with the possible risk of drop-out of participants
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