A Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients (PARAM2A)

May 16, 2019 updated by: University Hospital, Bordeaux

An Exploratory Study of the Feasibility of the Installation by a Paramedical Staff of a Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Service de neurologie motricité,Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: standardized meditation technique "body-scan"
Other: body-scan meditation
15 minutes audio-guided body-scan meditation
Diagnostic test: Psychological evaluation
NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Time Frame: 48 hours after admission
48 hours after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patient's eligibility and causes of non-eligibility
Time Frame: At inclusion (day 0)
At inclusion (day 0)
Rate of study drop-out
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Causes of study drop-outs
Time Frame: through study completion, an average of 1 year
by oral questionnaire
through study completion, an average of 1 year
Mean delay between admission and first meditation
Time Frame: After "body scan" meditation, an average of 48 hours after admission
After "body scan" meditation, an average of 48 hours after admission
Cause of failure of meditation administration within 48h
Time Frame: 48 hours after admission (day 0)
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)
48 hours after admission (day 0)
Percentage of improvement pain, anxiety and discomfort
Time Frame: before and after "body scan" meditation, an average of 48 hours after admission
by visual analog scales (VAS)
before and after "body scan" meditation, an average of 48 hours after admission
Percentage of improvement at the Parkinson's disease
Time Frame: before and after "body scan" meditation, an average of 48 hours after admission
by Anxiety Screening Questionnaire (PAS)
before and after "body scan" meditation, an average of 48 hours after admission
Percentage of improvement at the Parkinson's disease
Time Frame: before and after "body scan" meditation, an average of 48 hours after admission
by the Neuropsychiatric symptoms Inventory (NPI) total scores
before and after "body scan" meditation, an average of 48 hours after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Director: François TISON, Prof, University Hospital Bordeaux, France
  • Principal Investigator: Caroline GAUTIER, University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2018

Primary Completion (ACTUAL)

March 5, 2019

Study Completion (ACTUAL)

March 5, 2019

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (ACTUAL)

November 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 16, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2016/50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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