RehabilitationNCT04726774
Hypnosis for Fear of Falling in Older Adults
A study testing Hypnosis and Rehabilitation program in people with Rehabilitation and Fear of Falling, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Rehabilitation, Fear of Falling, Older Adults
- What is being tested?
- Hypnosis and Rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jan 2019to 25 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- admitted in a rehabilitation program specialized in falls and fracture risk assessment and management
- 65 years and over
Who cannot join
- psychiatrics disorders
- did not speak french
- lacking decisional capacity
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Rehabilitation and Geriatrics, Geneva University Hospitals
Geneva, CH-1211
About this study
Official title: Hypnosis for Fear of Falling in Hospitalized Older Adults? : a Feasibility Randomized Controlled Study.
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.
Read the 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.
- Conditions
- Rehabilitation, Fear of Falling, Older Adults
- Being tested
- Hypnosis, Rehabilitation program
- Keywords
- hypnosis, fear of falling, rehabilitation, older adults, feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
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 programBehavioural
Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises). Education of risk of falling and prevention of falls.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis group | Experimental | The intervention consisted of two hypnosis sessions by a physician trained in medical hypnosis. The hypnosis group received also the usual rehabilitation program. Receives: Behavioral: Hypnosis; Behavioral: Rehabilitation program |
| Control group | Active comparator | 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. Receives: Behavioral: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
recruitement rate was defined by the number of included patients dividing by the number of weeks it takes to include them.
Measured: through study completion, an average of 6 months
feasibility of hypnosis
hypnosis adherence was defined by the number of total sessions of hypnosis
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Impact of hypnosis on fear of falling
by comparing scores of questionnaires validated to assess fear of falling between groups
Measured: through study completion, an average of 6 months
Impact of hypnosis on functional
by comparing functional ability assessed by Functional Independency Measure score and Short Physical Performance Battery score between both groups
Measured: through study completion, an average of 6 months
Impact of hypnosis on length of stay
length of stay was defined by the number of day of hospitalization, and was compared between both groups
Measured: through study completion, an average of 6 months
Impact of hypnois on number of drugs
number of drugs at the end of hospitalization
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start17 Jan 2019
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Trombetti, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726774
- Sponsor's protocol ID
- BASEC 2018-01550
- Other IDs
- SNCTP000003110
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37559112
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis for Fear of Falling in Hospitalized Older Adults? : a Feasibility Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04726774
- Acronym / sponsor ID
- BASEC 2018-01550
- Conditions
- Rehabilitation, Fear of Falling, Older Adults
- Keywords
- hypnosis, fear of falling, rehabilitation, older adults, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis group | Experimental | Behavioral: Hypnosis, Behavioral: Rehabilitation programThe intervention consisted of two hypnosis sessions by a physician trained in medical hypnosis. The hypnosis group received also the usual rehabilitation program. |
| Control group | Active comparator | Behavioral: Rehabilitation programThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- admitted in a rehabilitation program specialized in falls and fracture risk assessment and management
- 65 years and over
Key exclusion criteria (3 listed)
- psychiatrics disorders
- did not speak french
- lacking decisional capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisTwo 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. | Behavioural | Hypnosis group |
| Rehabilitation programIntensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises). Education of risk of falling and prevention of falls. | Behavioural | Control group, Hypnosis group |
Primary outcome
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.
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
4 secondary outcomes
Impact of hypnosis on fear of falling
Time frame: through study completion, an average of 6 months
Impact of hypnosis on functional
Time frame: 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
Impact of hypnois on number of drugs
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Derived from this study: PubMed 37559112Cuvelier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and Rehabilitation program in people with Rehabilitation and Fear of Falling, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.