Virtual Reality-based Induction to Improve Positive Body Image in Low Back Pain Patients.

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.

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Low-back Pain
• Intervention / Treatment: Behavioral: Positive Appreciation of Body Functionality Induction; Behavioral: Negative Appreciation of Body Functionality Induction

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Arnau de Vilanova Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Low back pain; Participants with low back pain. They will perform the two induction procedures.

Behavioral: Positive Appreciation of Body Functionality Induction; 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.; Behavioral: Negative Appreciation of Body Functionality Induction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The whole study is conducted in a single experimental session: Immediately before induction procedures.
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.	The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
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.	The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
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.	The whole study is conducted in a single experimental session: Immediately before induction procedures.
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.	The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
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.	The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
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.	The whole study is conducted in a single experimental session: Immediately before induction procedures.
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.	The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
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.	The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
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.	The whole study is conducted in a single experimental session: Immediately before the induction procedures and immediately after the first applied induction procedure.
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.	The whole study is conducted in a single experimental session: Immediately before the first induction procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity: Baseline	Baseline measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".	The whole study is conducted in a single experimental session: Immediately before the induction procedures.
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".	The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
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".	The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
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".	The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
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".	The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
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".	The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
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".	The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Rosa M Baños, PhD, University of Valencia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEIm: 30/2021; FPU20/05798 (Other Grant/Funding Number: Ministerio de Ciencia e Innovación)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No