Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether a positive body image-based intervention is able to improve pain disability interference and emotional distress in people with chronic low back pain
Patients will receive 4 sessions approaching 5 different clinical modules Pain Psychoeducation Body Awareness Pain Acceptance Body Appreciation and Functionality and Gratitude 2 sessions will include virtual reality VR environments to enhance the clinical outcomes
Researchers will analyse changes in the variables of interest after intervention compared to baseline
Patients will receive 4 sessions approaching 5 different clinical modules Pain Psychoeducation Body Awareness Pain Acceptance Body Appreciation and Functionality and Gratitude 2 sessions will include virtual reality VR environments to enhance the clinical outcomes
Researchers will analyse changes in the variables of interest after intervention compared to baseline
Detailed Description:
The purpose of this intervention is to examine the effects of a positive body image-based intervention using virtual reality to improve pain interference and emotional distress
The first session will be dedicated to psychoeducation about pain Investigators will discuss what chronic pain is what factors influence pain chronification body image and a brief presentation of the modules
In the second session a brief introduction to body awareness will be given and a VR environment will be used to carry out a body scan
In the third session Acceptance of pain will be worked on and a VR environment will be used to work on some variables related to the chronification of pain such as paradoxical control or avoidance
In the fourth session the modules of Appreciation and Gratitude will be addressed
Each session will last approximately one hour First participants will be screened to check eligibility inclusionexclusion criteria Second eligible participants will complete baseline measures
The study will be conducted following the principles stated in the Declaration of Helsinki
The design chosen for the intervention will be a Multiple Baseline Single Case Design Data will be analysed by visual and statistical analysis For visual analysis the mean andor median will be used to report the level trend and stability of the within phase data For between-phase data Nonoverlap Statistics such as Nonoverlap of All Pairs NAP will be used For statistical analyses a Cohens Difference of Means Cohens d will be used to estimate the effect size at the individual level and multilevel analyses for across-case effect sizes
The first session will be dedicated to psychoeducation about pain Investigators will discuss what chronic pain is what factors influence pain chronification body image and a brief presentation of the modules
In the second session a brief introduction to body awareness will be given and a VR environment will be used to carry out a body scan
In the third session Acceptance of pain will be worked on and a VR environment will be used to work on some variables related to the chronification of pain such as paradoxical control or avoidance
In the fourth session the modules of Appreciation and Gratitude will be addressed
Each session will last approximately one hour First participants will be screened to check eligibility inclusionexclusion criteria Second eligible participants will complete baseline measures
The study will be conducted following the principles stated in the Declaration of Helsinki
The design chosen for the intervention will be a Multiple Baseline Single Case Design Data will be analysed by visual and statistical analysis For visual analysis the mean andor median will be used to report the level trend and stability of the within phase data For between-phase data Nonoverlap Statistics such as Nonoverlap of All Pairs NAP will be used For statistical analyses a Cohens Difference of Means Cohens d will be used to estimate the effect size at the individual level and multilevel analyses for across-case effect sizes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None