Virtual Reality-based Induction to Improve Positive Body Image in Low Back Pain Patients.
Primary Purpose
Chronic Low-back Pain, Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Positive Appreciation of Body Functionality Induction
Negative Appreciation of Body Functionality Induction
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Low-back Pain
Eligibility Criteria
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
Sites / Locations
- Arnau de Vilanova HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low back pain
Arm Description
Participants with low back pain. They will perform the two induction procedures.
Outcomes
Primary Outcome Measures
Appreciation of Body Functionality: Baseline
Baseline measure of Functionality Appreciation Scale (FAS). The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Appreciation of Body Functionality: Post positive induction procedure
Post positive induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Appreciation of Body Functionality: Post negative induction procedure
Post negative induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Body Awareness: Body Trusting; Baseline
Baseline measure of "Trusting" subscale from Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2). The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Body Awareness: Body Trusting; Post positive induction procedure
Post positive induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Body Awareness: Body Trusting; Post negative induction procedure
Post negative induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Baseline
Baseline measure of PBCC subscale from Experience of Embodiment Scale (EES). The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedure
Post positive induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post negative induction procedure
Post negative induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Attitudes or Feelings towards One's Own Body; Baseline
Baseline measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
Attitudes or Feelings towards One's Own Body; Post first induction procedure
Post first induction procedure measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
Secondary Outcome Measures
Pain intensity: Baseline
Baseline measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Pain intensity: Post positive induction procedure
Post positive induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Pain intensity: Post negative induction procedure
Post negative induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Fear of movement; Post positive induction procedure
Post positive induction measure of fear of movement with a single item (numerical rating scale); ranging from 0: " No fear" to 10: "maximum fear".
Fear of movement; Post negative induction procedure
Post negative induction measure of fear of movement with a single item (numerical rating scale); ranging from 0: " No fear" to 10: "maximum fear".
Task difficulty; Post positive induction procedure
Post positive induction measure of task difficulty with a single item (numerical rating scale); ranging from 0: "very easy" to 10: "very hard".
Task difficulty; Post negative induction procedure
Post negative induction measure of task difficulty with a single item (numerical rating scale); ranging from 0: "very easy" to 10: "very hard".
Full Information
NCT ID
NCT06054074
First Posted
June 20, 2023
Last Updated
September 21, 2023
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT06054074
Brief Title
Virtual Reality-based Induction to Improve Positive Body Image in Low Back Pain Patients.
Official Title
Efficacy of a Positive Induction Through the Use of a Virtual Reality-based Program to Modify Positive Body Image Related Variables in Patients With Low Back Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.
Participants will receive both a positive and a negative induction of the appreciation of body functionality. This induction consists of an elaborated narrative to increase/decrease the appreciation of functionality. In addition, each induction includes a virtual costume representing their body's strengths or weaknesses to enrich the induction. After both induction procedures, participants will perform activities of daily living involving the use of the lumbar region in virtual reality. Subsequently, the different variables of interest will be assessed before and after each induction.
Researchers will analyze changes in the variables of interest after induction procedures compared to baseline.
Detailed Description
The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.
Firstly, improvement in the study variables is expected after the positive induction. Secondly, the opposite results are expected after negative induction. Thirdly, a greater change is expected in the group of patients with low back pain.
The whole study is conducted in one single 1-hour session. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures. Third, participants will be exposed to both induction procedures, counterbalancing the order. At the end of each induction, they will have to perform different virtual reality-based tasks of daily life that involve the use of the lumbar region, such as placing books on a bookshelf, throwing objects into a trash can or painting a wall. Fourth, state measures will be applied to assess the change in the study variables.
The study will be conducted following the principles stated in the Declaration of Helsinki.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Low Back Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participants dont know the condition
Allocation
N/A
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low back pain
Arm Type
Experimental
Arm Description
Participants with low back pain. They will perform the two induction procedures.
Intervention Type
Behavioral
Intervention Name(s)
Positive Appreciation of Body Functionality Induction
Intervention Description
The positive induction takes place in a virtual environment of a dressing room and includes the following methods to induce positive appreciation of body functionality: 1) a narrative that aims to take the participants back to a time in the past when they held a higher positive body image. 2) A green virtual costume, representing their body at that time in the past and the positive attitude and feelings towards their body. 3) Five daily life tasks involving the use of the lower back, accompanied by auditory reminders and visual cues (green costume) to preserve the induction effect.
Intervention Type
Behavioral
Intervention Name(s)
Negative Appreciation of Body Functionality Induction
Intervention Description
The negative induction takes place in a virtual environment of a dressing room and includes the following methods to induce a lower appreciation of body functionality: 1) a narrative that aims to take the participants back to a time in the past when they held a lower positive body image. 2) A red virtual costume, representing their body at that time in the past and the negative attitude and feelings towards their body. 3) Five daily life tasks involving the use of the lower back, accompanied by auditory reminders and visual cues (red costume) to preserve the induction effect.
Primary Outcome Measure Information:
Title
Appreciation of Body Functionality: Baseline
Description
Baseline measure of Functionality Appreciation Scale (FAS). The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Time Frame
The whole study is conducted in a single experimental session: Immediately before induction procedures.
Title
Appreciation of Body Functionality: Post positive induction procedure
Description
Post positive induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Time Frame
The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Title
Appreciation of Body Functionality: Post negative induction procedure
Description
Post negative induction measure of FAS. The scores range from 1 to 5, where higher scores indicates higher levels of appreciation of body functionality.
Time Frame
The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Title
Body Awareness: Body Trusting; Baseline
Description
Baseline measure of "Trusting" subscale from Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2). The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Time Frame
The whole study is conducted in a single experimental session: Immediately before induction procedures.
Title
Body Awareness: Body Trusting; Post positive induction procedure
Description
Post positive induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Time Frame
The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Title
Body Awareness: Body Trusting; Post negative induction procedure
Description
Post negative induction measure of "Trusting" subscale from MAIA-2. The scores range from 0 to 5, where higher scores indicate a higher level of trust in one's own body.
Time Frame
The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Title
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Baseline
Description
Baseline measure of PBCC subscale from Experience of Embodiment Scale (EES). The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Time Frame
The whole study is conducted in a single experimental session: Immediately before induction procedures.
Title
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedure
Description
Post positive induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Time Frame
The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Title
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post negative induction procedure
Description
Post negative induction measure of PBCC subscale from EES. The scores range from 1 to 5, where higher scores indicates a more positive experience of embodiment.
Time Frame
The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Title
Attitudes or Feelings towards One's Own Body; Baseline
Description
Baseline measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
Time Frame
The whole study is conducted in a single experimental session: Immediately before the induction procedures and immediately after the first applied induction procedure.
Title
Attitudes or Feelings towards One's Own Body; Post first induction procedure
Description
Post first induction procedure measure of a semantic differential developed to assess attitudes and feelings towards one's own body. The scores range from 0 to 10, with higher scores representing a more positive evaluation of the one's own body.
Time Frame
The whole study is conducted in a single experimental session: Immediately before the first induction procedure.
Secondary Outcome Measure Information:
Title
Pain intensity: Baseline
Description
Baseline measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Time Frame
The whole study is conducted in a single experimental session: Immediately before the induction procedures.
Title
Pain intensity: Post positive induction procedure
Description
Post positive induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Time Frame
The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
Title
Pain intensity: Post negative induction procedure
Description
Post negative induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".
Time Frame
The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
Title
Fear of movement; Post positive induction procedure
Description
Post positive induction measure of fear of movement with a single item (numerical rating scale); ranging from 0: " No fear" to 10: "maximum fear".
Time Frame
The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
Title
Fear of movement; Post negative induction procedure
Description
Post negative induction measure of fear of movement with a single item (numerical rating scale); ranging from 0: " No fear" to 10: "maximum fear".
Time Frame
The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
Title
Task difficulty; Post positive induction procedure
Description
Post positive induction measure of task difficulty with a single item (numerical rating scale); ranging from 0: "very easy" to 10: "very hard".
Time Frame
The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
Title
Task difficulty; Post negative induction procedure
Description
Post negative induction measure of task difficulty with a single item (numerical rating scale); ranging from 0: "very easy" to 10: "very hard".
Time Frame
The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angel Zamora, MD
Phone
655184247
Ext
+34
Email
angel.zamora@uv.es
First Name & Middle Initial & Last Name or Official Title & Degree
Rocío Herrero, PhD
Email
ro.herrero.09@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa M Baños, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arnau de Vilanova Hospital
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Zamora, MD
Phone
655184247
Email
angelzamora1616@gmail.com
First Name & Middle Initial & Last Name & Degree
Rocío Herrero, PhD
Email
ro.herrero.09@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosa M Baños, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
28822275
Citation
Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
Results Reference
background
PubMed Identifier
30513087
Citation
Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
Results Reference
background
PubMed Identifier
32554242
Citation
Piran N, Teall TL, Counsell A. The experience of embodiment scale: Development and psychometric evaluation. Body Image. 2020 Sep;34:117-134. doi: 10.1016/j.bodyim.2020.05.007. Epub 2020 Jun 14.
Results Reference
background
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Virtual Reality-based Induction to Improve Positive Body Image in Low Back Pain Patients.
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