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

Study Overview
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: body-scan meditation
* Diagnostic Test: Psychological evaluation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients that received a first experience of standardized body scan meditation within 48H 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 |  | At inclusion (day 0) | 
| Rate of study drop-out |  | through study completion, an average of 1 year | 
| Causes of study drop-outs | by oral questionnaire | through study completion, an average of 1 year | 
| Mean delay between admission and first meditation |  | After body scan meditation, an average of 48 hours after admission | 
| 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) | 48 hours after admission (day 0) | 
| Percentage of improvement pain, anxiety and discomfort | 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 | 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 | by the Neuropsychiatric symptoms Inventory (NPI) total scores | before and after body scan meditation, an average of 48 hours after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, anxiety, meditation, in-patients