- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04726774
Hypnosis for Fear of Falling in Older Adults
Hypnosis for Fear of Falling in Hospitalized Older Adults? : a Feasibility Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Geneva, Switzerland, CH-1211
- Department of Rehabilitation and Geriatrics, Geneva University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- admitted in a rehabilitation program specialized in falls and fracture risk assessment and management
- 65 years and over
Exclusion Criteria:
- psychiatrics disorders
- did not speak french
- lacking decisional capacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises).
Education of risk of falling and prevention of falls.
|
ACTIVE_COMPARATOR: 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.
|
Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises).
Education of risk of falling and prevention of falls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment
Time Frame: 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.
|
through study completion, an average of 6 months
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feasibility of hypnosis
Time Frame: through study completion, an average of 6 months
|
hypnosis adherence was defined by the number of total sessions of hypnosis
|
through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of hypnosis on fear of falling
Time Frame: through study completion, an average of 6 months
|
by comparing scores of questionnaires validated to assess fear of falling between groups
|
through study completion, an average of 6 months
|
Impact of hypnosis on functional
Time Frame: through study completion, an average of 6 months
|
by comparing functional ability assessed by Functional Independency Measure score and Short Physical Performance Battery score between both groups
|
through study completion, an average of 6 months
|
Impact of hypnosis on length of stay
Time Frame: through study completion, an average of 6 months
|
length of stay was defined by the number of day of hospitalization, and was compared between both groups
|
through study completion, an average of 6 months
|
Impact of hypnois on number of drugs
Time Frame: through study completion, an average of 6 months
|
number of drugs at the end of hospitalization
|
through study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BASEC 2018-01550
- SNCTP000003110 (REGISTRY: SNCTP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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