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

May 16, 2019 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Service de neurologie motricité,Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: standardized meditation technique "body-scan"
Other: body-scan meditation
15 minutes audio-guided body-scan meditation
Diagnostic test: Psychological evaluation
NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Time Frame: 48 hours after admission
48 hours after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of patient's eligibility and causes of non-eligibility
Time Frame: At inclusion (day 0)
At inclusion (day 0)
Rate of study drop-out
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Causes of study drop-outs
Time Frame: through study completion, an average of 1 year
by oral questionnaire
through study completion, an average of 1 year
Mean delay between admission and first meditation
Time Frame: After "body scan" meditation, an average of 48 hours after admission
After "body scan" meditation, an average of 48 hours after admission
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)
48 hours after admission (day 0)
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)
before and after "body scan" meditation, an average of 48 hours after admission
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)
before and after "body scan" meditation, an average of 48 hours after admission
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
before and after "body scan" meditation, an average of 48 hours after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: François TISON, Prof, University Hospital Bordeaux, France
  • Principal Investigator: Caroline GAUTIER, University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2016/50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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