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

NCT ID: NCT03349554

Last Updated: 2019-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2019-03-05

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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standardized meditation technique "body-scan"

Group Type EXPERIMENTAL

body-scan meditation

Intervention Type OTHER

15 minutes audio-guided body-scan meditation

Psychological evaluation

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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body-scan meditation

15 minutes audio-guided body-scan meditation

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François TISON, Prof

Role: STUDY_DIRECTOR

University Hospital Bordeaux, France

Caroline GAUTIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

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Service de neurologie motricité,Hôpital Pellegrin

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2016/50

Identifier Type: -

Identifier Source: org_study_id

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