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Completed

NCT Number: NCT03349554

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

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.

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Key information

Conditions

Parkinson's Disease Anxiety Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de neurologie motricité,Hôpital Pellegrin

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

body-scan meditation

Other

15 minutes audio-guided body-scan meditation

Psychological evaluation

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

Primary outcomes

  1. 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

  1. Rate of patient's eligibility and causes of non-eligibility

    Time frame: At inclusion (day 0)

  2. Rate of study drop-out

    Time frame: through study completion, an average of 1 year

  3. Causes of study drop-outs

    Time frame: through study completion, an average of 1 year

    by oral questionnaire

  4. Mean delay between admission and first meditation

    Time frame: After "body scan" meditation, an average of 48 hours after admission

  5. Cause of failure of meditation administration within 48h

    Time frame: 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)

  6. Percentage of improvement pain, anxiety and discomfort

    Time frame: before and after "body scan" meditation, an average of 48 hours after admission

    by visual analog scales (VAS)

  7. Percentage of improvement at the Parkinson's disease

    Time frame: before and after "body scan" meditation, an average of 48 hours after admission

    by Anxiety Screening Questionnaire (PAS)

  8. Percentage of improvement at the Parkinson's disease

    Time frame: before and after "body scan" meditation, an average of 48 hours after admission

    by the Neuropsychiatric symptoms Inventory (NPI) total scores

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: PARAM2A

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2017
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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