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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06054074
• Other study ID #: CEIm: 30/2021
• Secondary ID: FPU20/05798
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 24, 2024

Study information

• Verified date: June 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 24, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Arnau de Vilanova Hospital	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.