Parkinson's Disease
Conditions
Keywords
Parkinson's disease, anxiety, meditation, in-patients
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.
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
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* Dementia, delusions or hallucination not permitting an informed consent or necessitating immediate and urgent sedation * Patient under law protection * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients that received a first experience of standardized body scan meditation within 48H after admission | 48 hours after admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of study drop-out | through study completion, an average of 1 year | — |
| Causes of study drop-outs | through study completion, an average of 1 year | by oral questionnaire |
| Mean delay between admission and first meditation | After body scan meditation, an average of 48 hours after admission | — |
| Rate of patient's eligibility and causes of non-eligibility | At inclusion (day 0) | — |
| Percentage of improvement pain, anxiety and discomfort | before and after body scan meditation, an average of 48 hours after admission | by visual analog scales (VAS) |
| Percentage of improvement at the Parkinson's disease | before and after body scan meditation, an average of 48 hours after admission | by Anxiety Screening Questionnaire (PAS) |
| Cause of failure of meditation administration within 48h | 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) |
Countries
France
Outcome results
None listed