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

Not Applicable
Completed
Conditions
Low Back Pain
Chronic Low-back Pain
Interventions
Behavioral: Positive Appreciation of Body Functionality Induction
Behavioral: Negative Appreciation of Body Functionality Induction
Registration Number
NCT06054074
Lead Sponsor
University of Valencia
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
53
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Low back painNegative Appreciation of Body Functionality InductionParticipants with low back pain. They will perform the two induction procedures.
Low back painPositive Appreciation of Body Functionality InductionParticipants with low back pain. They will perform the two induction procedures.
Primary Outcome Measures
NameTimeMethod
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedureThe whole study is conducted in a single experimental session: Immediately after 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.

Appreciation of Body Functionality: Post positive induction procedureThe whole study is conducted in a single experimental session: Immediately after 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.

Body Awareness: Body Trusting; BaselineThe whole study is conducted in a single experimental session: Immediately before induction procedures.

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.

Body Awareness: Body Trusting; Post positive induction procedureThe whole study is conducted in a single experimental session: Immediately after 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.

Body Awareness: Body Trusting; Post negative induction procedureThe whole study is conducted in a single experimental session: Immediately after 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.

Appreciation of Body Functionality: Post negative induction procedureThe whole study is conducted in a single experimental session: Immediately after 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.

Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post negative induction procedureThe whole study is conducted in a single experimental session: Immediately after 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.

Appreciation of Body Functionality: BaselineThe whole study is conducted in a single experimental session: Immediately before induction procedures.

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.

Positive Embodiment: Positive Body Connection and Comfort (PBCC); BaselineThe whole study is conducted in a single experimental session: Immediately before induction procedures.

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.

Attitudes or Feelings towards One's Own Body; Post first induction procedureThe whole study is conducted in a single experimental session: Immediately before the 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.

Attitudes or Feelings towards One's Own Body; BaselineThe whole study is conducted in a single experimental session: Immediately before the induction procedures and immediately after the first applied induction procedure.

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.

Secondary Outcome Measures
NameTimeMethod
Pain intensity: BaselineThe whole study is conducted in a single experimental session: Immediately before the induction procedures.

Baseline measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".

Task difficulty; Post positive induction procedureThe whole study is conducted in a single experimental session: Immediately after the 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".

Pain intensity: Post positive induction procedureThe whole study is conducted in a single experimental session: Immediately after positive induction procedure.

Post positive induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".

Fear of movement; Post positive induction procedureThe whole study is conducted in a single experimental session: Immediately after the 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".

Task difficulty; Post negative induction procedureThe whole study is conducted in a single experimental session: Immediately after the 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".

Pain intensity: Post negative induction procedureThe whole study is conducted in a single experimental session: Immediately after negative induction procedure.

Post negative induction measure of pain (numerical rating scale). The scores ranges to 0: "no pain" to 10: "maximum pain".

Fear of movement; Post negative induction procedureThe whole study is conducted in a single experimental session: Immediately after the 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".

Trial Locations

Locations (1)

Arnau de Vilanova Hospital

🇪🇸

Valencia, Spain

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