Parkinson's DiseasePARAM2ANCT03349554
A Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients
A study testing body-scan meditation and Psychological evaluation in people with Parkinson's Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- body-scan meditation and Psychological evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2018to 5 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia, delusions or hallucination not permitting an informed consent or necessitating immediate and urgent sedation
- Patient under law protection
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- body-scan meditation, Psychological evaluation
- Keywords
- Parkinson's disease, anxiety, meditation, in-patients
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body-scan meditationOther
15 minutes audio-guided body-scan meditation
Psychological evaluationDiagnostic test
NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation
| Study group | Role | What they receive |
|---|---|---|
| standardized meditation technique "body-scan" | Experimental | Not described Receives: Other: body-scan meditation; Diagnostic Test: Psychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Measured: 48 hours after admission
Secondary outcomes (8)
Rate of patient's eligibility and causes of non-eligibility
Measured: At inclusion (day 0)
Rate of study drop-out
Measured: through study completion, an average of 1 year
Causes of study drop-outs
by oral questionnaire
Measured: through study completion, an average of 1 year
Mean delay between admission and first meditation
Measured: After "body scan" meditation, an average of 48 hours after admission
Cause of failure of meditation administration within 48h
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)
Measured: 48 hours after admission (day 0)
Percentage of improvement pain, anxiety and discomfort
by visual analog scales (VAS)
Measured: before and after "body scan" meditation, an average of 48 hours after admission
Percentage of improvement at the Parkinson's disease
by Anxiety Screening Questionnaire (PAS)
Measured: before and after "body scan" meditation, an average of 48 hours after admission
Percentage of improvement at the Parkinson's disease
by the Neuropsychiatric symptoms Inventory (NPI) total scores
Measured: before and after "body scan" meditation, an average of 48 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start23 Mar 2018
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François TISON, Prof, Study director, University Hospital Bordeaux, FranceCaroline GAUTIER, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349554
- Sponsor's protocol ID
- CHUBX 2016/50
- Acronym
- PARAM2A
- Status last verified
- Mar 2018
- First submitted
- 26 Oct 2017
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03349554
- Acronym / sponsor ID
- PARAM2A / CHUBX 2016/50
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, anxiety, meditation, in-patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standardized meditation technique "body-scan" | Experimental | Other: body-scan meditation, Diagnostic Test: Psychological evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Dementia, delusions or hallucination not permitting an informed consent or necessitating immediate and urgent sedation
- Patient under law protection
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body-scan meditation15 minutes audio-guided body-scan meditation | Other | standardized meditation technique "body-scan" |
| Psychological evaluationNPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation | Diagnostic test | standardized meditation technique "body-scan" |
Primary outcome
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Time frame: 48 hours after admission
8 secondary outcomes
Rate of patient's eligibility and causes of non-eligibility
Time frame: At inclusion (day 0)
Rate of study drop-out
Time frame: through study completion, an average of 1 year
Causes of study drop-outs
Time frame: 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
Cause of failure of meditation administration within 48h
Time frame: 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
Percentage of improvement at the Parkinson's disease
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François TISON, Prof study director
University Hospital Bordeaux, France
Caroline GAUTIER principal investigator
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body-scan meditation and Psychological evaluation in people with Parkinson's Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission (time frame: 48 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.