Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2019-01-17
2019-07-25
Brief Summary
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Detailed Description
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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.
Fear of falling was assessed by different validated scales. Each scale was completed by each participant three times (week 0 (at baseline): before intervention; week 1 (during intervention): between the two hypnosis sessions; week 2 (at the end of the study): after all interventions), with or without the help of the occupational therapist.
Descriptive statistics were reported as mean ± standard deviation or number (percent). The hypnosis and the control groups were compared at baseline using t-tests or Fisher's exact test as appropriate. Longitudinal data were analyzed according to the intention-to-treat concept. Longitudinal data for fear of falling scores, Functional Independence Measure score, and Short Physical Performance Battery score, were analyzed using linear mixed-effects regression models, a negative binomial model for in-hospital falls, and t-tests for medications and length of stay. The incidence of in-hospital falls during hospital stay was analyzed using a negative binomial regression model.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Hypnosis group
The intervention consisted of two hypnosis sessions by a physician trained in medical hypnosis. The hypnosis group received also the usual rehabilitation program.
Hypnosis
Two sessions of hypnosis, about 30 minutes each, 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.
Each sessions of hypnosis includes 3 phases : induction, walk perception alteration and post-hypnotic suggestion.
Rehabilitation program
Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises). Education of risk of falling and prevention of falls.
Control group
The control group follow the usual rehabilitation program which 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.
Rehabilitation program
Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises). Education of risk of falling and prevention of falls.
Interventions
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Hypnosis
Two sessions of hypnosis, about 30 minutes each, 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.
Each sessions of hypnosis includes 3 phases : induction, walk perception alteration and post-hypnotic suggestion.
Rehabilitation program
Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises). Education of risk of falling and prevention of falls.
Eligibility Criteria
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Inclusion Criteria
* 65 years and over
Exclusion Criteria
* did not speak french
* lacking decisional capacity
65 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Andrea Trombetti
Professor Andrea Trombetti, MD
Locations
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Department of Rehabilitation and Geriatrics, Geneva University Hospitals
Geneva, , Switzerland
Countries
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References
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Cuvelier C, Hars M, Zamorani-Bianchi MP, Herrmann FR, Wieczorkiewicz CD, Zekry D, Gold G, Trombetti A. Hypnosis to reduce fear of falling in hospitalized older adults: a feasibility randomized controlled trial. Pilot Feasibility Stud. 2023 Aug 9;9(1):139. doi: 10.1186/s40814-023-01366-3.
Other Identifiers
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SNCTP000003110
Identifier Type: REGISTRY
Identifier Source: secondary_id
BASEC 2018-01550
Identifier Type: -
Identifier Source: org_study_id
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