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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
body-scan meditation
Psychological evaluation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's disease, anxiety, meditation, in-patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de neurologie motricité,Hôpital Pellegrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

standardized meditation technique "body-scan"

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of patient's eligibility and causes of non-eligibility
Rate of study drop-out
Causes of study drop-outs
by oral questionnaire
Mean delay between admission and first meditation
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)
Percentage of improvement pain, anxiety and discomfort
by visual analog scales (VAS)
Percentage of improvement at the Parkinson's disease
by Anxiety Screening Questionnaire (PAS)
Percentage of improvement at the Parkinson's disease
by the Neuropsychiatric symptoms Inventory (NPI) total scores

Full Information

First Posted
October 26, 2017
Last Updated
May 16, 2019
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03349554
Brief Title
A Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients
Acronym
PARAM2A
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
March 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, anxiety, meditation, in-patients

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standardized meditation technique "body-scan"
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
body-scan meditation
Intervention Description
15 minutes audio-guided body-scan meditation
Intervention Type
Diagnostic Test
Intervention Name(s)
Psychological evaluation
Intervention Description
NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation
Primary Outcome Measure Information:
Title
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Time Frame
48 hours after admission
Secondary Outcome Measure Information:
Title
Rate of patient's eligibility and causes of non-eligibility
Time Frame
At inclusion (day 0)
Title
Rate of study drop-out
Time Frame
through study completion, an average of 1 year
Title
Causes of study drop-outs
Description
by oral questionnaire
Time Frame
through study completion, an average of 1 year
Title
Mean delay between admission and first meditation
Time Frame
After "body scan" meditation, an average of 48 hours after admission
Title
Cause of failure of meditation administration within 48h
Description
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)
Title
Percentage of improvement pain, anxiety and discomfort
Description
by visual analog scales (VAS)
Time Frame
before and after "body scan" meditation, an average of 48 hours after admission
Title
Percentage of improvement at the Parkinson's disease
Description
by Anxiety Screening Questionnaire (PAS)
Time Frame
before and after "body scan" meditation, an average of 48 hours after admission
Title
Percentage of improvement at the Parkinson's disease
Description
by the Neuropsychiatric symptoms Inventory (NPI) total scores
Time Frame
before and after "body scan" meditation, an average of 48 hours after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François TISON, Prof
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caroline GAUTIER
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de neurologie motricité,Hôpital Pellegrin
City
Bordeaux
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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