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The Effect of Solution-focused Group Therapy for Pain Management in Patients With Spinal Cord Injury

Primary Purpose

Pain Management, Life Quality, Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
solution-focused group therapy
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain Management focused on measuring spinal cord injury, pain management, pain intensity, pain self-efficacy, solution-focused group therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients diagnosed with spinal cord injury as being in compliance with the Taiwan National Health Insurance's definition

Exclusion Criteria:

  • Psychiatric disabilities
  • Intellectual disabilities
  • Unconscious patients
  • Patients in critical condition
  • Bedridden patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    the six weeks solution-focused pain management groups

    Arm Description

    Outcomes

    Primary Outcome Measures

    The pain intensity and pain fear scale
    The pain intensity and pain fear scale is based on the Numeric Rating Scale, asking participants "the intensity of pain in your body now" and "the degree of fear towards the future caused by your physical pain", from a minimum of 0 to a maximum of 10.
    Brief Pain Inventory-Pain inference
    Participants are asked to answer the extent to which pain interferes with daily life, mood, relationships with others, sleep, breathing, cough, mobility, and enjoyment of life over the past 24 hours, with a score of 0 representing no interference to 10 points representing complete interference. The total score ranges from 0 to 70, and the higher the score, the greater the degree of interference from pain.
    Pain management self-efficacy subscale and symptom response self-efficacy subscale within Chronic Pain Self-Efficacy Scale (CPSS)
    Since most of the patients with spinal cord injury were injured in the whole body or in the lower part of their body, the self-efficacy of their physical functions could not be revealed. Therefore, the 9 questions regarding the body function self-efficacy subscale were removed and revised into 13 questions regarding the pain self-efficacy. Participants used 0 to 10 points to indicate their degree of confidence in management and response to the situation described; 0 points indicate complete uncertainty, 10 points indicate 10% confidence, and the total score ranged from 0 to 130 points.
    The depression scale uses Patient Health Questionnaires-9
    participants are asked to answer the frequency of symptoms described in the topic over the past two weeks, namely 0 points in case there were no symptoms, several days (1 point), more than one week (2 points) and almost every day (3 points) score. The total score ranges from 0 to 27 points. The higher the score, the more serious the depression.
    Demoralization scale - Mandarin Version (DS-M)
    DS-M includes loss of meaning, dysphoria, disheartenment, sense of failure, helplessness, and other items for total of 24 questions, with a score ranging from 0 to 4, namely from completely disagree to completely agree. The total score ranges from 0 to 96 points. The higher the score, the higher the degree of demoralization.
    Post-traumatic growth inventory (PTGI)
    PTGI assesses an individual's possible positive psychological changes after major stress events, including increasing the relation with others, opening up to new possibilities, increasing personal strength, appreciation of life, and spiritual change. The scale has a total of 21 questions, 0-5 points indicating a scale from no change to a very large degree of change. The total score ranges from 0 to 105 points. Spinal cord injury is mostly caused by accidents. So for a part of those with post-traumatic stress disorder (PTSD), it is estimated that post-traumatic growth can provide information about the psychological recovery of people with spinal cord injury.
    The quality of life adopts Taiwan's concise version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF-TW)
    It is made up of the 26 questions of WHOQOL-BREF , plus 2 questions related to Taiwan, for a total of 28 questions. The individual score ranges from 1 to 5. The total score ranges from 0 to 140. The higher the score, the better the quality of life.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2019
    Last Updated
    June 18, 2019
    Sponsor
    National Taipei University of Nursing and Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03991689
    Brief Title
    The Effect of Solution-focused Group Therapy for Pain Management in Patients With Spinal Cord Injury
    Official Title
    The Effect of Solution-focused Group Therapy for Pain Management in Patients With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 29, 2014 (Actual)
    Primary Completion Date
    December 31, 2015 (Actual)
    Study Completion Date
    December 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taipei University of Nursing and Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Objective: to verify the effect of solution-focused group therapy (SFBT) on pain management as well as physiological, psychological and social adaptation in patients with spinal cord injury. Setting: for matters of convenience, the samples were collected at medical and rehabilitation centers in Taiwan. Twenty-six patients with spinal cord injuries and neuropathic pain were invited to join the four pain management groups. Method: In the case of patients with spinal cord injury affected by neuropathic pain, a solution-focused pain management group therapy was conducted once a week for 6 weeks, 90 minutes each time; fear avoidance theory and acceptance and commitment therapy was used for pain management, using solution-focus group counseling strategies to guide group members to achieve pain management goals by accepting pain and establishing goals.The group effectiveness was assessed before and after the group intervention in terms of pain intensity (0-10 numeric rating scale), brief pain inventory-pain inference, chronic pain self-efficacy scale, pain fear (0-10 numeric rating scale), depression (patient health questionnaire-9), demoralization (demoralization scale), post-traumatic growth inventory and life quality (WHOQOL-BREF). Then we analyzed the correlation between the difference values of the variables before and after the test in order to understand the clinical application of the pain management group therapy for patients with spinal cord injury.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain Management, Life Quality, Spinal Cord Injuries
    Keywords
    spinal cord injury, pain management, pain intensity, pain self-efficacy, solution-focused group therapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    the six weeks solution-focused pain management groups
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    solution-focused group therapy
    Intervention Description
    Participants began a 90-minute solution-focused pain management group, which lasted for six weeks, and after the group ended, the questionnaire post-test was carried out, and a total of 26 participants thus completed their group journey. The group effect was evaluated by the difference between the scores of the questionnaires before and after the group.
    Primary Outcome Measure Information:
    Title
    The pain intensity and pain fear scale
    Description
    The pain intensity and pain fear scale is based on the Numeric Rating Scale, asking participants "the intensity of pain in your body now" and "the degree of fear towards the future caused by your physical pain", from a minimum of 0 to a maximum of 10.
    Time Frame
    6 weeks
    Title
    Brief Pain Inventory-Pain inference
    Description
    Participants are asked to answer the extent to which pain interferes with daily life, mood, relationships with others, sleep, breathing, cough, mobility, and enjoyment of life over the past 24 hours, with a score of 0 representing no interference to 10 points representing complete interference. The total score ranges from 0 to 70, and the higher the score, the greater the degree of interference from pain.
    Time Frame
    6 weeks
    Title
    Pain management self-efficacy subscale and symptom response self-efficacy subscale within Chronic Pain Self-Efficacy Scale (CPSS)
    Description
    Since most of the patients with spinal cord injury were injured in the whole body or in the lower part of their body, the self-efficacy of their physical functions could not be revealed. Therefore, the 9 questions regarding the body function self-efficacy subscale were removed and revised into 13 questions regarding the pain self-efficacy. Participants used 0 to 10 points to indicate their degree of confidence in management and response to the situation described; 0 points indicate complete uncertainty, 10 points indicate 10% confidence, and the total score ranged from 0 to 130 points.
    Time Frame
    6 weeks
    Title
    The depression scale uses Patient Health Questionnaires-9
    Description
    participants are asked to answer the frequency of symptoms described in the topic over the past two weeks, namely 0 points in case there were no symptoms, several days (1 point), more than one week (2 points) and almost every day (3 points) score. The total score ranges from 0 to 27 points. The higher the score, the more serious the depression.
    Time Frame
    6 weeks
    Title
    Demoralization scale - Mandarin Version (DS-M)
    Description
    DS-M includes loss of meaning, dysphoria, disheartenment, sense of failure, helplessness, and other items for total of 24 questions, with a score ranging from 0 to 4, namely from completely disagree to completely agree. The total score ranges from 0 to 96 points. The higher the score, the higher the degree of demoralization.
    Time Frame
    6 weeks
    Title
    Post-traumatic growth inventory (PTGI)
    Description
    PTGI assesses an individual's possible positive psychological changes after major stress events, including increasing the relation with others, opening up to new possibilities, increasing personal strength, appreciation of life, and spiritual change. The scale has a total of 21 questions, 0-5 points indicating a scale from no change to a very large degree of change. The total score ranges from 0 to 105 points. Spinal cord injury is mostly caused by accidents. So for a part of those with post-traumatic stress disorder (PTSD), it is estimated that post-traumatic growth can provide information about the psychological recovery of people with spinal cord injury.
    Time Frame
    6 weeks
    Title
    The quality of life adopts Taiwan's concise version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF-TW)
    Description
    It is made up of the 26 questions of WHOQOL-BREF , plus 2 questions related to Taiwan, for a total of 28 questions. The individual score ranges from 1 to 5. The total score ranges from 0 to 140. The higher the score, the better the quality of life.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with spinal cord injury as being in compliance with the Taiwan National Health Insurance's definition Exclusion Criteria: Psychiatric disabilities Intellectual disabilities Unconscious patients Patients in critical condition Bedridden patients

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Solution-focused Group Therapy for Pain Management in Patients With Spinal Cord Injury

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