"Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".
NCT ID: NCT06506604
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2024-06-03
2024-07-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Participants with low back pain. Multiple Base Line Single Case Design - 7 days wait
Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.
CLEVER
CLEVER: A positive body image-based intervention for Chronic Low Back Pain.
Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.
Participants with low back pain. Multiple Base Line Single Case Design - 10 days wait
Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.
CLEVER
CLEVER: A positive body image-based intervention for Chronic Low Back Pain.
Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.
Participants with low back pain. Multiple Base Line Single Case Design - 14 days wait
Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.
CLEVER
CLEVER: A positive body image-based intervention for Chronic Low Back Pain.
Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.
Participants with low back pain. Multiple Base Line Single Case Design - 11 days wait
Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.
CLEVER
CLEVER: A positive body image-based intervention for Chronic Low Back Pain.
Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.
Interventions
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CLEVER
CLEVER: A positive body image-based intervention for Chronic Low Back Pain.
Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Spinal tumor, infection or fracture
* Systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...)
* Fibromyalgia
* Cauda equina syndrome
* History of spinal surgery
* Musculoskeletal injury of lower extremities
18 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Rosa M. Baños Rivera
Full Professor
Principal Investigators
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Rosa M. Baños, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Locations
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Arnau de Vilanova Hospital
Valencia, Valencia, Spain
Countries
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References
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Valenzuela-Moguillansky C, Reyes-Reyes A, Gaete MI. Exteroceptive and Interoceptive Body-Self Awareness in Fibromyalgia Patients. Front Hum Neurosci. 2017 Mar 13;11:117. doi: 10.3389/fnhum.2017.00117. eCollection 2017.
Bailey KA, Gammage KL, van Ingen C, Ditor DS. "It's all about acceptance": A qualitative study exploring a model of positive body image for people with spinal cord injury. Body Image. 2015 Sep;15:24-34. doi: 10.1016/j.bodyim.2015.04.010. Epub 2015 May 21.
Alleva JM, Diedrichs PC, Halliwell E, Peters ML, Dures E, Stuijfzand BG, Rumsey N. More than my RA: A randomized trial investigating body image improvement among women with rheumatoid arthritis using a functionality-focused intervention program. J Consult Clin Psychol. 2018 Aug;86(8):666-676. doi: 10.1037/ccp0000317.
Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736.
Other Identifiers
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PID2020-115609RB-C21
Identifier Type: -
Identifier Source: org_study_id
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