NCT04726774

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 15, 2021

Last Update Submit

January 25, 2021

Conditions

Keywords

hypnosisfear of fallingrehabilitationolder adultsfeasibility study

Outcome Measures

Primary Outcomes (2)

  • Feasibility of recruitment

    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

  • feasibility of hypnosis

    hypnosis adherence was defined by the number of total sessions of hypnosis

    through study completion, an average of 6 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

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.

Behavioral: HypnosisBehavioral: 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.

Behavioral: Rehabilitation program

Interventions

HypnosisBEHAVIORAL

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.

Hypnosis group

Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises). Education of risk of falling and prevention of falls.

Control groupHypnosis group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • admitted in a rehabilitation program specialized in falls and fracture risk assessment and management
  • years and over

You may not qualify if:

  • psychiatrics disorders
  • did not speak french
  • lacking decisional capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Geriatrics, Geneva University Hospitals

Geneva, CH-1211, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

HypnosisRehabilitation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Andrea Trombetti, MD

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 27, 2021

Study Start

January 17, 2019

Primary Completion

July 25, 2019

Study Completion

July 25, 2019

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations