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Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Relaxation guided imagery
Relaxing music
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Imagery, Pain, Depression, Non-Motor

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with idiopathic Parkinson's disease suffering from significant pain.

Exclusion Criteria:

  • Dementia
  • Hearing impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Relaxation guided imagery

    Relaxing music

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain scores on the visual analog scale
    Numeric rating scale after relaxation guided imagery as compared with baseline

    Secondary Outcome Measures

    The brief Pain Inventory
    The brief Pain Inventory after relaxation guided imagery as compared with baseline

    Full Information

    First Posted
    May 19, 2013
    Last Updated
    November 5, 2014
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01865097
    Brief Title
    Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease
    Official Title
    Pilot Study of Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome non-motor symptom is pain. Currently these symptoms are treated with medication with limited success. Our study aims to determine whether relaxation guided imagery can alleviate pain in Parkinson's disease patients.
    Detailed Description
    Parkinson's disease patients with severe pain without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on pain. This will be a phase I, controlled, single blind and randomized efficacy study in 2 parallel groups. The study will include a baseline assessment of pain severity where after the intervention group will undergo relaxation guided imagery and the control group will listen to relaxing music. After these relaxation session patients will receive a CD with either relaxation guided imagery or relaxing music to listen to at home. Pain severity will be recorded for the following 6 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Imagery, Pain, Depression, Non-Motor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Relaxation guided imagery
    Arm Type
    Experimental
    Arm Title
    Relaxing music
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxation guided imagery
    Intervention Description
    An individualized relaxation guided imagery session will be conducted. After the session patients will be given a CD with the relaxation guided imagery and asked to listen to it at home.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxing music
    Intervention Description
    An individualized session of listening to relaxing music will be conducted. After the session patients will be given a CD with the relaxing music and asked to listen to it at home.
    Primary Outcome Measure Information:
    Title
    Pain scores on the visual analog scale
    Description
    Numeric rating scale after relaxation guided imagery as compared with baseline
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    The brief Pain Inventory
    Description
    The brief Pain Inventory after relaxation guided imagery as compared with baseline
    Time Frame
    6 weeks
    Other Pre-specified Outcome Measures:
    Title
    Health status measured by Parkinson's Disease Questionnaire 39(PDQ39)
    Description
    PDQ39 after relaxation guided imagery as compared with baseline
    Time Frame
    6 weeks
    Title
    Depression scores on Beck Depression Inventory (BDI)
    Description
    BDI after relaxation guided imagery as compared with baseline
    Time Frame
    6 weeeks
    Title
    Non-motor symptom screening questionaire
    Description
    Non-motor symptom screening questionaire after relaxation guided imagery as compared with baseline
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with idiopathic Parkinson's disease suffering from significant pain. Exclusion Criteria: Dementia Hearing impairment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ilana Schlesinger, M.D.
    Organizational Affiliation
    Rambam Health Care Campus, Haifa, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease

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