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临床试验/NCT06973941
NCT06973941已完成不适用

Effectiveness and Feasibility of Virtual Reality Relaxation Compared to Guided Imagery Relaxation in Older Adults With Mental Illness: A Randomized Controlled Study

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
State anxiety

研究概览

简要总结

This clinical trial is exploring whether virtual reality (VR) can be a helpful and practical tool for reducing stress and anxiety in older adults receiving mental health care. The study compares two common relaxation methods: one using traditional guided imagery (a technique that uses calming mental pictures) and one using immersive VR technology.

Participants are older adults with mental health conditions who take part in a single relaxation session using either VR or guided imagery. Before and after the session, researchers measure how relaxed, calm, and emotionally well the participants feel.

The study aims to answer several questions:

Do both methods reduce anxiety and negative emotions right after the session?

Do they increase relaxation, well-being, and positive feelings?

Is VR more effective than guided imagery for this group?

Does feeling more immersed in the VR environment lead to lower anxiety?

Researchers are also evaluating whether these techniques are comfortable and practical for older adults by looking at factors like satisfaction, drop-out rates, and ease of use.

Because relaxation exercises are already used in older adult mental health care, this research could help improve how such techniques are delivered - especially if VR turns out to be a powerful, accessible option for this population.

详细描述

This single-blinded pilot randomized controlled trial investigates the effectiveness and feasibility of virtual reality (VR)-based relaxation compared to guided imagery (GI)-based relaxation among older adults receiving inpatient psychiatric care. The study targets geriatric patients with various mental health diagnoses to evaluate whether immersive VR experiences offer comparable or superior benefits to a traditional guided imagery intervention.

The primary objectives are to determine whether:

Both interventions lead to an immediate reduction in state anxiety, negative affect, and perceived stress.

Both interventions result in an immediate increase in well-being, positive affect, and perceived relaxation.

Participants in the VR group show greater improvements in psychological outcomes than those in the GI group.

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
否

入选标准

  • •in psychiatric treatment at the St. Hedwig Hospital Berlin, Germany
  • •a psychiatric diagnosis (according to ICD-10)
  • •aged 55 years and older
  • •ability to understand the content of the study and provide written informed consent

排除标准

  • •insufficient proficiency in German language
  • •acute aggression
  • •acute suicidality

研究组 & 干预措施

Virtual Reality

Experimental

Prior to the relaxation exercise, the patients receive a short training session on how to wear the VR headset, for which Oculus Meta Quest 2 (Reality Labs, Meta Platforms Inc) is used, and on how to navigate in the virtual world. Patients are informed that the investigator would stay in the room during the relaxation exercise but would not actively interact with them until the 10-minute intervention was over (except if they needed assistance or wished to stop). After the investigator starts the VR relaxation application, which is part of the app "Nature Treks VR" by Greenergames (released on May 21, 2019), the patients put on the headset and proceed with the relaxation exercise. The virtual world is a natural environment providing a view of a forest with a nearby river, mountains in the distance, flowers and animals, accompanied by relaxing music and the sound of birds chirping. All patients experience the same relaxing environment.

干预措施: Virtual reality relaxation (Other)

Guided Imagery

Active Comparator

Patients receive an audio guided dream journey, conducted by one of the investigators. The dream journey is exclusively developed for the purpose of this study by an experienced psychiatrist to ensure comparability and to control for familiarity, since this type of relaxation exercise is implemented in regular geriatric psychiatric care. Duration (10 minutes in total) and content (forest, natural environment) of the GI-based dream journey are tailored as precisely as possible to the relaxing VR application. Thus, the dream journey describes a similar natural scene taking place in a forest with a river, flowers and animals in the surrounding area and mountains in the distance, accompanied by relaxing music and nature sounds. We ensure to only include specific elements, e.g. deers and rabbits, that are also visible in the VR environment and avoid any additional instructions not provided in the VR application.

干预措施: Guided imagery relaxation (Other)

结局指标

主要结局

State anxiety

时间窗: One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.

Assessed using the German version of the state subscale of the State-Trait Anxiety Inventory (STAI-X1; Laux et al., 1981; Spielberger et al., 1970), which has good psychometric properties, such as a high internal consistency (α = .90) (Laux et al., 1981). The STAI-X1 is a self-report questionnaire comprising 20 items in total, some of which need to be reversed. Short statements, such as 'I am nervous.' (indicating presence of anxiety) or 'I feel calm' (indicating absence of anxiety), had to be evaluated on a 4-point scale ranging from 1 = 'not at all' to 4 = 'very much'. Patients are asked to indicate to what extent each statement applied to them at that moment. A sum score between 20 and 80 iscalculated, with higher values indicating a higher level of state anxiety.

次要结局

  • Positive and negative affect(One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.)
  • Perceived stress(One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.)
  • Perceived relaxation(One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.)
  • Overall well-being(One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.)
  • Patients' satisfaction(One post-intervention-measurement during a single session that takes 35-45 minutes.)
  • Patients' experience(One post-intervention-measurement during a single session that takes 35-45 minutes.)
  • Drop out rates(One measurement during a single session that takes 35-45 minutes.)
  • Motion Sickness(One post-intervention-measurement during a single VR session that takes 35-45 minutes.)
  • Sense of presence(One post-intervention-measurement during a single VR session that takes 35-45 minutes.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Anna

Associate Professor

Charite University, Berlin, Germany

研究点 (1)

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