Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT06506604
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".
Sponsor:
University of Valencia
Organization:
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:
COMPLETED
Status Verified Date:
2025-01
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:
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 inclusion/exclusion 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 (SCD-MB). Data will be analysed by visual and statistical analysis. For visual analysis, the mean and/or 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 Cohen's Difference of Means (Cohen's 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 inclusion/exclusion 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 (SCD-MB). Data will be analysed by visual and statistical analysis. For visual analysis, the mean and/or 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 Cohen's Difference of Means (Cohen's 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:
False
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?:
False
Is an FDA AA801 Violation?: