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

University Hospital of Bordeaux

Status: Completed

Conditions: Parkinson's Disease

Treatments: Diagnostic Test: Psychological evaluation; Other: body-scan meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT03349554

CHUBX 2016/50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

standardized meditation technique "body-scan"

Experimental group

Treatment:

Diagnostic Test: Psychological evaluation

Other: body-scan meditation