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

NCT ID: NCT06054074

Last Updated: 2024-06-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-01-24

Brief Summary

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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

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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.

Conditions

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Chronic Low-back Pain Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Participants dont know the condition

Study Groups

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Low back pain

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

Group Type EXPERIMENTAL

Positive Appreciation of Body Functionality Induction

Intervention Type 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.

Negative Appreciation of Body Functionality Induction

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Rosa M. Baños Rivera

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 28822275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30513087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32554242 (View on PubMed)

Other Identifiers

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FPU20/05798

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CEIm: 30/2021

Identifier Type: -

Identifier Source: org_study_id

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