Hypnosis for Fear of Falling in Hospitalized Older Adults? : a Feasibility Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
Fear of falling is associated with numerous negative health outcomes in older adults and can limit rehabilitation. Few treatments are effective in fear of falling. Hypnosis is now recognized as an effective treatment for a variety of conditions, especially anxiety and pain, which can be integrated safely with conventional medicine. Therefore, the objective was to assess the feasibility of a randomized controlled trial to examine whether hypnosis reduces fear of falling in an inpatient geriatric population. In this randomized pilot trial, patients hospitalized in geriatric rehabilitation wards were randomly allocated to either an intervention group (hypnosis plus usual rehabilitation program) or a control group (usual rehabilitation program only). Primary feasibility outcomes were recruitment rate, retention rate, and adherence to the intervention. Secondary outcomes concerned the impact of hypnosis in rehabilitation in fear of falling scores, functional scores, length of stay, and drugs.
详细描述
This single-center randomized controlled feasibility trial was conducted in a 296 beds acute care and rehabilitation geriatric hospital of Geneva University Hospitals (Switzerland).
After consent, patients were randomized to either the intervention group or the control group. The randomization sequence was computer-generated (ratio 1:1) and concealed until official patient enrolment. All study staff members, including physiotherapists and occupational therapists, were blinded to group allocation, with the exception of the hypnotherapist. All statistical analyses were performed by a blinded statistician.
The intervention consisted of two hypnosis sessions of about 30 minutes, weekly provided, by a physician trained in medical hypnosis. Each session was realized as possible during walking, according to the agreement and the physical status of the participant. The intervention was provided in the complement of the usual rehabilitation program. Both the intervention and control groups received the usual rehabilitation program, a multifactorial fall-and-fracture risk-based assessment, and management intervention, which has been shown to be effective in improving physical parameters related to the risk of fall and disability among high-risk oldest-old patients. This program includes intensive physiotherapy for 2 weeks (i.e., focused on walking and enhancing balance exercises in group or individual and group) and patient education on the risk of falling and on prevention of falls.
The target sample size was 30 participants (15 participants in each group, pilot study). The study was approved by the State of Geneva's Ethics Committee (2018-01550). All patients provided written informed consent before any study-related procedure.
The feasibility of a randomized controlled trial with hypnosis in rehabilitation was assessed by recruitment rate, retention rate, adherence to hypnosis, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted in a rehabilitation program specialized in falls and fracture risk assessment and management
- •65 years and over
排除标准
- •psychiatrics disorders
- •did not speak french
- •lacking decisional capacity
结局指标
主要结局
Feasibility of recruitment
时间窗: through study completion, an average of 6 months
recruitement rate was defined by the number of included patients dividing by the number of weeks it takes to include them.
feasibility of hypnosis
时间窗: through study completion, an average of 6 months
hypnosis adherence was defined by the number of total sessions of hypnosis
次要结局
- Impact of hypnosis on fear of falling(through study completion, an average of 6 months)
- Impact of hypnosis on functional(through study completion, an average of 6 months)
- Impact of hypnosis on length of stay(through study completion, an average of 6 months)
- Impact of hypnois on number of drugs(through study completion, an average of 6 months)
研究者
Andrea Trombetti
Professor Andrea Trombetti, MD
University Hospital, Geneva
