Clinical trial NCT06054074: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Low Back Pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Appreciation of Body Functionality: Baseline
timeFrame: The whole study is conducted in a single experimental session: Immediately before induction procedures.
measure: Appreciation of Body Functionality: Post positive induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
measure: Appreciation of Body Functionality: Post negative induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
measure: Body Awareness: Body Trusting; Baseline
timeFrame: The whole study is conducted in a single experimental session: Immediately before induction procedures.
measure: Body Awareness: Body Trusting; Post positive induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
measure: Body Awareness: Body Trusting; Post negative induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
measure: Positive Embodiment: Positive Body Connection and Comfort (PBCC); Baseline
timeFrame: The whole study is conducted in a single experimental session: Immediately before induction procedures.
measure: Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
measure: Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post negative induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
measure: Attitudes or Feelings towards One's Own Body; Baseline
timeFrame: The whole study is conducted in a single experimental session: Immediately before the induction procedures and immediately after the first applied induction procedure.
measure: Attitudes or Feelings towards One's Own Body; Post first induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately before the first induction procedure.
Secondary outcomes:
measure: Pain intensity: Baseline
timeFrame: The whole study is conducted in a single experimental session: Immediately before the induction procedures.
measure: Pain intensity: Post positive induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after positive induction procedure.
measure: Pain intensity: Post negative induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after negative induction procedure.
measure: Fear of movement; Post positive induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
measure: Fear of movement; Post negative induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
measure: Task difficulty; Post positive induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.
measure: Task difficulty; Post negative induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Arnau de Vilanova Hospital
Study officials:
affiliation: University of Valencia
name: Rosa M Baños, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.