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Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury

Primary Purpose

Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pleasant guided imagery
Pain diary
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway)

Exclusion Criteria:

  • Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    guided imagery

    pain diary

    Arm Description

    CD

    Pain diary

    Outcomes

    Primary Outcome Measures

    Pain intensity
    as measured by a numerical rating scale (daily) and Brief pain questionnaire (BPI) (baseline and after 4 weeks)

    Secondary Outcome Measures

    BDI, BAI and SF36

    Full Information

    First Posted
    May 13, 2008
    Last Updated
    April 7, 2015
    Sponsor
    Norwegian University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00678548
    Brief Title
    Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury
    Official Title
    Effect of Positive Guided Imagery on Patients With in or Below-level Chronic Pain Related to Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to other projects priority
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic pain after spinal cord injury in or below the level of injury is a common problem and can be severe. The purpose of our study is to investigate the effect of pleasant guided imagery on spinal cord injured patients with chronic pain in or below the level of injury.
    Detailed Description
    The study is a controlled simple blind randomized prospective study. Subjects who live in Trøndelag ( Norway) and who have a traumatic or non traumatic spinal cord injury with chronic pain in or below the level of injury will be included in the study. Assessments: Pain will be measured with NRS(numeric pain rating scale) and BPIQ (Brief pain intervention questionnaire), anxiety and depression with BDI and BAI (Beck's depression and anxiety inventory) and quality of live with SF36 health survey. The subjects will be randomized in a treatment and control group. One group will use daily for four weeks a CD with a pleasant guided imagery, the other group will write a short pain diary. The NRS will be registered daily and the other assessments before and after the interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    guided imagery
    Arm Type
    Experimental
    Arm Description
    CD
    Arm Title
    pain diary
    Arm Type
    Active Comparator
    Arm Description
    Pain diary
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pleasant guided imagery
    Intervention Description
    CD with pleasant guided imagery
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pain diary
    Intervention Description
    Filling out a pain diary
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    as measured by a numerical rating scale (daily) and Brief pain questionnaire (BPI) (baseline and after 4 weeks)
    Time Frame
    four weeks
    Secondary Outcome Measure Information:
    Title
    BDI, BAI and SF36
    Time Frame
    pre and postintervention

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway) Exclusion Criteria: Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gunnar Leivseth, Professor MD
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury

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