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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Switzerland

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.

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 groups in NCT04726774
Study groupRoleWhat they receive
Hypnosis groupExperimentalThe 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 groupActive comparatorThe 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted27 Jan 2021
  2. Study start17 Jan 2019
  3. Primary completion25 Jul 2019
  4. Study completion25 Jul 2019

Resources

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)
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

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.

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