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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants dont know the condition
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with low back pain.
排除标准
- •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
结局指标
主要结局
Positive Embodiment: Positive Body Connection and Comfort (PBCC); Post positive induction procedure
时间窗: The 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 procedure
时间窗: The 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; Baseline
时间窗: The 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 procedure
时间窗: The 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 procedure
时间窗: The 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 procedure
时间窗: The 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 procedure
时间窗: The 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: Baseline
时间窗: The 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); Baseline
时间窗: The 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 procedure
时间窗: The 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; Baseline
时间窗: The 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.
次要结局
- Pain intensity: Baseline(The whole study is conducted in a single experimental session: Immediately before the induction procedures.)
- Task difficulty; Post positive induction procedure(The whole study is conducted in a single experimental session: Immediately after the positive induction procedure.)
- Pain intensity: Post positive induction procedure(The whole study is conducted in a single experimental session: Immediately after positive 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.)
- Task difficulty; Post negative induction procedure(The whole study is conducted in a single experimental session: Immediately after the negative 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 negative induction procedure(The whole study is conducted in a single experimental session: Immediately after the negative induction procedure.)
研究者
Rosa M. Baños Rivera
Full Professor
University of Valencia