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
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Imagery, Pain, Depression, Non-Motor
Eligibility Criteria
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
NCT ID
NCT01865097
First Posted
May 19, 2013
Last Updated
November 5, 2014
Sponsor
Rambam Health Care Campus
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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