Bottom-Up Virtual Nature Versus Top-Down Guided Imagery in Hospitalized Older Adults: A Randomized Parallel-Group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in anxiety symptoms (HADS-A)
研究概览
简要总结
Long hospital stays can be difficult for older adults. Being confined to a ward, with limited mobility and little access to the outdoors, may contribute to anxiety, low mood, and reduced well-being. Contact with nature is known to support relaxation and emotional recovery, but hospitalized patients often cannot go outside.
This study compares two ways of bringing a nature experience to patients who are staying in hospital. In the first approach, participants wear a virtual reality headset and watch 360-degree videos filmed in real natural settings near Budapest: a meadow, a stream, and a mountain. The nature scene reaches them through their eyes and ears. In the second approach, participants listen to a short recorded audio guide and picture the same three nature scenes in their own minds, with their eyes closed. Here the nature scene is created by their own imagination.
Both approaches use exactly the same nature themes. The only difference is how the experience reaches the person: from the outside through the senses, or from the inside through imagination. The study asks whether these two routes have different effects, and whether they can be told apart by measuring heart rate variability, which reflects how the body's automatic nervous system responds.
Participants are adults aged 65 or older who have been in hospital for at least two weeks. After joining the study, each participant is first observed for two weeks while receiving only their usual hospital care. This period serves as their own comparison. They are then assigned by chance to one of the two approaches and take part in three sessions over two weeks. Questionnaires and brief cognitive tests are completed at three points: when joining, before the sessions begin, and after the sessions end.
The main question is whether anxiety symptoms decrease more during the session period than during the preceding period of usual care. The study also looks at mood, attention and memory, well-being, and resilience.
详细描述
This is a prospective, two-arm, parallel-group randomized controlled trial conducted at two clinical sites of Semmelweis University: the Department of Geriatrics and Nursing Science, and the Department of Rehabilitation Medicine.
A distinctive feature of the design is that all participants undergo an observation period of equal length under treatment as usual before randomization, so that each participant serves as their own control for the pre-intervention period. This allows the change observed during the intervention period to be distinguished from time-dependent processes occurring during hospitalization itself. This design was chosen because neither a waiting-list control nor a no-treatment condition was considered ethically acceptable in this population.
Participants are enrolled after approximately two weeks of hospitalization (T0). A two-week observation period under usual care follows, during which a single resting heart rate variability recording is obtained. The T1 assessment is conducted at the end of this period, followed by randomization and three intervention sessions delivered over two weeks. The T2 assessment follows the intervention period. No follow-up assessment is conducted.
The two arms differ only in the processing route. The virtual reality arm delivers the natural environment as bottom-up perceptual input via a head-mounted display, using proprietary 360-degree videos recorded from a fixed tripod perspective at three locations near Budapest. The videos contain no narration or added music, only the natural soundscape of the location. The guided imagery arm delivers the same content as an internally generated, top-down process, using a standardized audio recording that begins with a brief breathing relaxation followed by the motif text. Both arms use identical standardized symbolic nature motifs (meadow, stream, mountain) drawn from the motif repertoire of Katathym Imaginative Psychotherapy. The design therefore does not compare an active intervention with a passive control, but two content-equivalent interventions that differ in their processing pathway.
Two primary outcomes are specified. The primary clinical outcome is the change in anxiety symptoms between T1 and T2. The primary mechanistic outcome is RMSSD recorded during the intervention sessions, computed from a five-minute artifact-free window in both arms. Heart rate variability is recorded in three contexts: once at rest during the observation period, during each intervention session, and during neuropsychological testing at each assessment point.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 开放（无盲法）
盲法说明
Neither participants nor facilitators can be masked given the nature of the interventions. Outcome assessments are conducted by ward clinical psychologists who may learn the allocation through routine patient contact; assessor masking is therefore not claimed. Heart rate variability data are processed using predefined automated parameters without knowledge of group allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Aged 65 years or older
- Receiving inpatient hospital care, with at least two weeks of hospitalisation at the time of enrolment
- Montreal Cognitive Assessment (Hungarian version) score of 18 or above, with education correction
- Physically able to safely wear a head-mounted virtual reality display
- Adequate corrected or uncorrected vision and hearing
- Able to communicate in Hungarian
- Stable psychiatric and cardiovascular condition, as determined from medical history and in consultation with the treating physician
- Able to provide independent written informed consent
排除标准
- Epilepsy with recurrent seizures, or photosensitivity
- Neurological condition associated with increased risk during virtual reality use, including Meniere's disease and significant carotid stenosis
- Active psychosis, hallucinations, or severe depression with psychotic features
- Open wound or skin lesion on the face, chronic neck pain, or spinal condition preventing safe use of the head-mounted display
- Severe uncorrectable sensory impairment
- Unstable psychotropic medication during the preceding eight weeks
- Regular use of analgesic or psychotropic medication that may substantially affect perception of the experience
- Active alcohol or substance use disorder within the past year
- Refusal or inability to provide informed consent
- Enrolment is deferred, rather than excluded, in the presence of active delirium or infectious illness, until the condition resolves.
研究组 & 干预措施
Immersive virtual reality nature exposure
Participants view 360-degree nature videos through a head-mounted display in a seated or semi-seated position. The videos were produced by the research team from a fixed tripod perspective at three locations near Budapest, corresponding to the three standardized motifs (meadow, stream, mountain). They contain no narration or added music, only the natural soundscape of the location. The viewpoint changes every five minutes. Exposure length ranges from 8 to 20 minutes according to participant tolerance. Three sessions are delivered over two weeks.
干预措施: Immersive virtual reality nature exposure (Device)
Guided imagery
Participants listen through headphones, in a seated or semi-seated position with eyes closed, to a standardized five-minute audio recording that begins with a brief breathing relaxation followed by the motif text. The motifs are identical to those presented in the virtual reality arm (meadow, stream, mountain). After the session, participants give a free verbal account of their experience. Three sessions are delivered over two weeks.
干预措施: Guided imagery (Behavioral)
结局指标
主要结局
Change in anxiety symptoms (HADS-A)
时间窗: Baseline, Week 2, and Week 4
Anxiety symptoms measured with the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Scores range from 0 to 21; lower scores indicate less anxiety. The primary comparison is the change during the intervention period (T1 to T2) relative to the change during the preceding usual care observation period (T0 to T1), with each participant serving as their own control.
Heart rate variability during intervention sessions (RMSSD)
时间窗: Week 2 through Week 4
Root mean square of successive differences (RMSSD) recorded during intervention sessions with an optical photoplethysmographic armband sensor and analysed with dedicated heart rate variability software. RMSSD is computed from a five-minute artifact-free window in both arms and expressed in milliseconds; higher values indicate greater parasympathetic activity. Recordings with more than 5 percent corrected beats are excluded.
次要结局
- Change in resilience (CD-RISC-10)(Baseline and Week 4)
- Change in depressive symptoms (HADS-D)(Baseline, Week 2, and Week 4)
- Change in depressive symptoms (GDS-15)(Baseline, Week 2, and Week 4)
- Change in global cognitive performance (MoCA)(Baseline, Week 2, and Week 4)
- Change in memory index (MoCA-MIS)(Baseline, Week 2, and Week 4)
- Change in attentional performance (MoCA attention subscale)(Baseline, Week 2, and Week 4)
- Change in processing speed (Trail Making Test A)(Baseline, Week 2, and Week 4)
- Change in quality of life (CASP-19)(Baseline and Week 4)
- Change in heart rate variability during cognitive testing (RMSSD)(Baseline, Week 2, and Week 4)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07765355
- 其他研究编号
- SE-VRGI-2025, BM/28270-1/2024
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (3个月后)
- 研究完成日期
- (3个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Individual participant data will not be shared publicly. The dataset contains detailed clinical, medication, and laboratory information collected from a small sample of hospitalised older adults at two clinical departments, and the combination of these variables would create a re-identification risk that pseudonymisation alone cannot adequately address. Aggregated and anonymised results will be reported in peer-reviewed publications. Requests for access to specific data supporting the published findings may be directed to the corresponding author and will be considered on a case-by-case basis, subject to institutional and ethical approval.