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
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
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
NCT ID
NCT03991689
First Posted
June 9, 2019
Last Updated
June 18, 2019
Sponsor
National Taipei University of Nursing and Health Sciences
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
Learn more about this trial
The Effect of Solution-focused Group Therapy for Pain Management in Patients With Spinal Cord Injury
We'll reach out to this number within 24 hrs