Can Virtual Reality Improve the Progressive Muscular Relaxation Technique Efficacy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change is being assessed between and within subjects in state-anxiety scores
研究概览
简要总结
The purposes of the current research project are as follows:
- investigate if the PMRT associated with a personalized-relaxing scenario in VR can facilitate the recalling of the relaxing image in the real world than the standard procedure (consisting of PMRT associated with the in-imagination exposure to a comfortable subjective context). The investigators assume that VR would be more efficient than in-imagination since it would make easy the visualization process favor people cope with more realistic sensory experiences than in-imagination exposure. Accordingly, the VR exposure would elicit the strongest association between the relaxation procedure (neutral stimulus, NS) and the relaxing context in VR (conditioning stimulus, CS);
- whether exposure to a personalized VREs has a more significant impact on anxiety, depression, stress, sense of presence, and quality of psychological well-being; these constructs are investigated by comparing the participants' performance on self-report questionnaires (described in the next section), before the start of the training (T0; baseline), at the end of all the four relaxing sessions, one week after the end of relaxation sessions (T1; day 7), and during follow up (T2; day 14);
- if the relaxing sessions administered via Zoom are more proper for managing anxiety and stress than a procedure learned via an audio registration.
Considering the ability to generate vivid visual images is positively associated with the capacity to feel present in a virtual world, all the participants are asked to fulfill two questionnaires before the VR or the Guided Imagery exposure to investigate the vividness and the capacity to control mental images respectively, and to control the impact of these two dependent variables on the sense of presence self-reported after the in imagination or VR exposure.
详细描述
Each participant is randomly assigned to one of the three following different conditions:
- Progressive Muscle Relaxation training via Zoom and Guided Imagery exposure A standardized protocol regarding the information on the training background is shared with participants.
Then, they are invited to participate in four individually PMRT sessions (two sessions per week) deployed via Zoom.
The fifth session (T1; day 7) is administered in-presence at the Virtual Reality Laboratory (A10-A11) - University of Padova; here, an in-imagination relaxing scenario is built up with the support of the Psychotherapist; then, participants are exposed to an in-vivo-PMRT-relaxing session conducted by the Psychotherapist, with the request to think about the in-imagination relaxing scenario, created before, during the progressive relaxation procedure.
In the follow-up phase (T2, day 14), the therapist asks to recover the in-imagination relaxing scenario and relax, giving participants the same time allowed for the last guided relaxing session. 2. Progressive Muscle Relaxation training via Zoom and personalized VR exposure PMRT sessions and expected time length are the same as for the first group. Differences regard the fifth session, where the relaxing scenario is built with the psychotherapist support based on the VR's tools. Indeed, during the in-presence session, participants are exposed to a merged personalized and natural VR scenario and PMRT session administered by the Oculus Quest 2 tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General population
- •Italian speaker
- •Adult (age=> 18)
- •Must be able to use a PC
- •Must be able to use a Smartphone
排除标准
- •Mental disorder diagnosis
- •Clinical diagnosis of a neurological disorder
- •Clinical diagnosis of epilepsy
- •Have cardiac pacemakers
- •Have metallic devices in the head-neck area
- •Clinical diagnosis of infectious disorders
- •Clinical diagnosis of gastrointestinal disorders
- •Open wounds at the face level
- •Clinical diagnosis of motor or visual dysfunctions
- •Neuromuscular pain prevent the use of Oculus Quest 2
结局指标
主要结局
Change is being assessed between and within subjects in state-anxiety scores
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in state-anxiety scores are assessed based on the State-Trait Anxiety Inventory-Y1 (State anxiety) before and after each sessions. The STAI-Y1 is a self-report questionnaire investigating the state anxiety based on a 4-point Likert scale (1-4). Scores ranging from 20 to 80. Higher scores indicated more state-anxiety severity.
Change is being assessed between and within subjects in levels of chronic non-specific arousal (stress)
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in levels of chronic nonspecific arousal (stress) scores are assessed by the "Depressive Anxiety Stress Scale-21-Stress subscale" based on a 4-point Likert scale (0-3). Scores ranging from 0 to 42 (the score will need to be multiplied by 2 to calculate the final score). Higher scores indicated higher level of stress.
Number of participants with VR-related side effects as assessed by the Virtual Reality Sickness Questionnaire and the investigators' observations.
时间窗: T1 (day 7)
Participants in the two experimental arms is asked to refer if the VR head mounted display was painful, too heavy, or uncomfortable. More in detail, participants is asked if they have experienced negative side effect during the Virtual Reality (VR) exposure based on the Virtual Reality Sickness Questionnaire (VRSQ), administered at the end of the VR exposure. This questionnaire is based on a dichotomous answer (Yes/No). During the VR experience, the investigator observe participant reactions and record behaviors and signs suggesting an unpleasant experience.
Change is being assessed between and within subjects in bodily anxiety sensations
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in bodily anxiety sensations scores are assessed based on the Self Assessment Manikin (SAM). The SAM is a non-verbal imagery-based assessment technique used to assess bodily anxiety sensations that directly measures the pleasure, arousal, and dominance associated with a person's affective reaction to a wide variety of stimuli. Each sensations is assessed on 5 different images distributed in order of size. Participants can tick either of the five pictures or any of the four spaces in between, making it essentially a 9-point Likert-scale. The SAM varies from a minimum score of 3 to a maximum score of 27. The huge non-verbal imagery are related with higher bodily anxiety sensations.
Change is being assessed between and within subjects in relaxation levels
时间窗: T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in relaxation levels are assessed based on the Visual Analog Scale administered before and after each sessions. This measure assess relaxation levels before and after each virtual reality experience. Participants had to express how relaxed they felt (0 =not at all relaxed; 10=completely relaxed; 0 =absent; 10=complete). Higher scores indicated higher relaxation levels.
Change is being assessed between and within subjects in depression scores
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in depression scores are assessed based on the "Depressive Anxiety Stress Scale-21-Depression subscale". Items are answered according on a 4-point Likert scale (0-3). Scores ranging from 0 to 42 (the scores will need to be multiplied by 2 to calculate the final score). Higher scores indicated more depression severity.
Change is being assessed between and within subjects in trait-anxiety scores
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in trait-anxiety scores are assessed based on the State-Trait Anxiety Inventory-Y2 (Trait Anxiety). The measure is a self-report questionnaire investigating the trait anxiety based on a 4-point Likert scale (1-4). Scores ranging from 20 to 80. Higher scores indicated higher trait-anxiety severity.
Change is being assessed between and within subjects in autonomic arousal, skeletal muscle effects, situational anxiety, subjective experience of anxious affect.
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in anxiety scores are assessed by the "Depressive Anxiety Stress Scale-21-Anxiety Subcale" based on a 4-point Likert scale (0-3). Scores ranging from 0 to 42 (the scores will need to be multiplied by 2 to calculate the final score). Higher scores indicated more anxiety severity.
Change is being assessed between and within subjects in sense of presence scores related to the Virtual Reality and Guided Imagery experiences
时间窗: T1 (day 7), T2 (day 14)
Differences between groups and change from T1 and T2 phases in sense of presence related to the VR or Guided Imagery experience are assessed at two different assessment times based on a Visual Analogue Scale and the ITC-Sense of Presence Inventory (ITC-SOPI). The ITC-SOPI is a self-report questionnaire assessing the sense of presence. Items are rated on a 5-point Likert scale (1-5). Scores ranging from 36 to 180. To obtain the scores for each of the scales, the average of the items have to be calculated. Higher scores indicated higher sense of presence.
Change is being assessed between and within subjects in quality of life scores
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Change from baseline to T1 and T2 phases in quality of life scores on the Psychological General Well-Being Index are assessed at three different assessment times. The measure consists of 22 self-administered items, rated on a 6-point scale (0-5), which assess the psychological and general well-being. Scores ranging from 0 to 110. Higher scores indicated a better well-being state.
Change is being assessed between and within subjects in coping strategies scores
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Change from baseline to T1 and T2 phases in coping strategies are assessed at three different assessment times. The Coping Orientation to the Problems Experienced-New Italian Version is a self-report questionnaire developed to assess the different coping strategies people use in response to stress; it is based on 60 items rated on a 4-point scale (1-4). Total scores ranging from 60 to 240. Higher scores indicate that a certain cope strategies is frequently used by the person.
Change is being assessed between and within subjects in hearth frequency
时间窗: T0 (baseline), T1 (day 7), T2 (day 14)
Differences between groups and change from baseline to T1 and T2 phases in hearth frequency are assessed based on the Xiaomi Mi Band 2 tool. It is used in three different assessment times (T0, T1, T2). During T1 and T2 hearth frequency is measured before, during, and after the in-presence relaxation session.
次要结局
未报告次要终点
研究者
Caterina Novara
Professor
University of Padova