"Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Body Disability
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants are blind to the variables of change.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals with low back pain.
Exclusion Criteria
- •Meeting any of the following medical conditions:
- •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
Arms & Interventions
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.
Intervention: CLEVER (Behavioral)
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.
Intervention: CLEVER (Behavioral)
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.
Intervention: CLEVER (Behavioral)
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.
Intervention: CLEVER (Behavioral)
Outcomes
Primary Outcomes
Body Disability
Time Frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Roland-Morris Questionnaire (RMQ) is a 24-item patient-reported outcome measure those inquiries about pain-related disability. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24.
Pain Interference and Pain Intensity
Time Frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
The Brief Pain Inventory (BPI) scale was developed to assess the severity of pain and its impact on functioning. The scale consists of 9 items with qualitative and quantitative data on the following dimensions: "Worst pain in last 24 hours", "Least pain in last 24 hours", "Pain on average" and "Pain right now".
Emotional Distress
Time Frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
The 4-item Brief Assessment of Distress about Pain (BADP) scale was developed to assess anxiety, fear, and depression related to pain, as well as an overall evaluation of distress about pain. Items are scored from 0 ("Not at all") to 4 ("Extreme"), for a total BADP score ranging from 0 to 16.
Level of Quality of Life
Time Frame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
The EuroQol-5D (EQ-5D) scale is a 5-item scale to assess the quality of life of patients with several pathologies, chronic pain included. The individual assesses his or her own state of health, first in levels of severity by dimensions (descriptive system) and then on a more general visual analogue scale (VAS).
Secondary Outcomes
- Chronic Pain Acceptance(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).)
- Fear of movement(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).)
- Body Awareness(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).)
- Body Appreciation(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale -'I FEEL LOVE AND RESPECT FOR MY BODY'- will be administered daily for 43 days via MPATH.)
- Appreciation of Body Functionality(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).)
- Pain Catastrophizing(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).)
- Depression(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).)
- Anxiety(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).)
- Body Awareness(The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale: 'I NOTICE WHEN I FEEL UNCOMFORTABLE IN MY BODY´ will be administered daily for 43 days via MPATH.)
Investigators
Rosa M. Baños Rivera
Full Professor
University of Valencia