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

NCT06054074 | Completed

• 2 other identifiers: CEIm: 30/2021FPU20/05798
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain; Low Back Pain

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (7)

• Pain intensity: Baseline

  The whole study is conducted in a single experimental session: Immediately before the induction procedures.

• Pain intensity: Post positive induction procedure

  The whole study is conducted in a single experimental session: Immediately after positive induction procedure.

• Pain intensity: Post negative induction procedure

  The whole study is conducted in a single experimental session: Immediately after negative induction procedure.

• Fear of movement; Post positive induction procedure

  The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.

• Fear of movement; Post negative induction procedure

  The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.

Study Arms (1)

Low back pain

EXPERIMENTAL

Participants with low back pain. They will perform the two induction procedures.

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

Interventions

Positive Appreciation of Body Functionality Induction BEHAVIORAL

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.

Low back pain

Negative Appreciation of Body Functionality Induction BEHAVIORAL

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.

Low back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with low back pain.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Arnau de Vilanova Hospital

Valencia, 46015, Spain

Location

Related Publications (3)

• 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.

  PMID: 28822275 BACKGROUND

• 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.

  PMID: 30513087 BACKGROUND

• 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.

  PMID: 32554242 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosa M Baños, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants dont know the condition
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: September 26, 2023
• Study Start: November 1, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

ES (1)