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CompletedNCT03349554PARAM2AUpdated May 17, 2019

A Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients

An interventional study of body-scan meditation and Psychological evaluation in Parkinson's Disease, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-17.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to constitute a proof of concept study for a larger study investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD) based on the results of a preliminary feasibility.

Read the detailed description

Neuropsychiatric and behavioral non motor symptoms are common in PD often requiring hospitalization and/or specific drug management. Mindfulness-based stress reduction (MBSR) programs have proved to be efficacious in PD both for the management of motor and non-motor symptoms. This is however the case only in out-patients and by using standardized 8 weeks programs. The team has experienced in the hospitalization unit that methods derived from the MBSR program such as the "body scan", administered by the paramedical personnel, is of great help for the non-pharmacological management of anxiety and agitation in PD, avoiding physical contention in many cases. Based on this experience the study aims at evaluating the feasibility and preliminary efficacy of a simple and standardized administration of the "body scan" meditation in the management of anxiety and agitation in PD admitted in the unit since less than 48h.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • Parkinson's disease
  • anxiety
  • meditation
  • in-patients
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Parkinson's disease
  • Age over 18
  • Admitted in the unit since less than 3 days
  • Presenting at least 3 symptoms with a severity rated > 2 at the Hamilton anxiety scale (HAM-A)
  • Patients with social security insurance
  • Informed consent signed

Exclusion criteria

Exclusion Criteria:

  • Dementia, delusions or hallucination not permitting an informed consent or necessitating immediate and urgent sedation
  • Patient under law protection
  • Pregnant or breastfeeding women
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    standardized meditation technique "body-scan"

    Other: body-scan meditation · Diagnostic Test: Psychological evaluation

Interventions

  • Otherbody-scan meditation

    15 minutes audio-guided body-scan meditation

  • Diagnostic testPsychological evaluation

    NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation

05

What researchers measure

Primary outcomes

  1. Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission

    Time frame: 48 hours after admission

Secondary outcomes

  1. Rate of patient's eligibility and causes of non-eligibility

    Time frame: At inclusion (day 0)

  2. Rate of study drop-out

    Time frame: through study completion, an average of 1 year

  3. Causes of study drop-outs

    by oral questionnaire

    Time frame: through study completion, an average of 1 year

  4. Mean delay between admission and first meditation

    Time frame: After "body scan" meditation, an average of 48 hours after admission

  5. Cause of failure of meditation administration within 48h

    Failure factors: related to staffing (insufficient, untrained...), related to the organization of the service (double room / individual), related to the patient (visits, temporary refusal), related to the equipment (unavailable, non-functional)

    Time frame: 48 hours after admission (day 0)

  6. Percentage of improvement pain, anxiety and discomfort

    by visual analog scales (VAS)

    Time frame: before and after "body scan" meditation, an average of 48 hours after admission

  7. Percentage of improvement at the Parkinson's disease

    by Anxiety Screening Questionnaire (PAS)

    Time frame: before and after "body scan" meditation, an average of 48 hours after admission

  8. Percentage of improvement at the Parkinson's disease

    by the Neuropsychiatric symptoms Inventory (NPI) total scores

    Time frame: before and after "body scan" meditation, an average of 48 hours after admission

06

Study locations

1 site
  • Service de neurologie motricité,Hôpital Pellegrin
    Bordeaux, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03349554
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Nov 21, 2017
Start date
Mar 23, 2018
Primary completion
Mar 5, 2019
Completion
Mar 5, 2019
Last update
May 17, 2019

Study contacts

François TISON, Prof
study director · University Hospital Bordeaux, France
Caroline GAUTIER
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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