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

NCT ID: NCT01865097

Last Updated: 2014-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Relaxation guided imagery

Group Type EXPERIMENTAL

Relaxation guided imagery

Intervention Type BEHAVIORAL

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.

Relaxing music

Group Type ACTIVE_COMPARATOR

Relaxing music

Intervention Type BEHAVIORAL

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.

Interventions

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Relaxation guided imagery

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

Relaxing music

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Dementia
* Hearing impairment
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ilana Schlesinger

Director, Movement Disorders Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilana Schlesinger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus, Haifa, Israel

Other Identifiers

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0494-12

Identifier Type: -

Identifier Source: org_study_id

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