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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
standardized meditation technique "body-scan"
Intervention: body-scan meditation (Other)
standardized meditation technique "body-scan"
Intervention: Psychological evaluation (Diagnostic Test)
Outcomes
Primary Outcomes
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Time Frame: 48 hours after admission
Secondary Outcomes
- Percentage of improvement at the Parkinson's disease(before and after "body scan" meditation, an average of 48 hours after admission)
- Mean delay between admission and first meditation(After "body scan" meditation, an average of 48 hours after admission)
- Rate of study drop-out(through study completion, an average of 1 year)
- Percentage of improvement pain, anxiety and discomfort(before and 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))
- Causes of study drop-outs(through study completion, an average of 1 year)
- Cause of failure of meditation administration within 48h(48 hours after admission (day 0))