Study on the Application of Gratitude Intervention in Patients With Spinal Cord Injury
Primary Purpose
Patients ; Spinal Cord Injury
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thanksgiving diary intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Patients ; Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- Conformed to the 6th edition of neurological classification of spinal cord injury issued by the American Spinal Cord injury Society, and confirmed by CT or MRI imaging; sequelae such as different degrees of limb motor dysfunction caused by spinal cord injury; age ≥ 18 years old; returned to the community after discharge from the hospital for at least 2 weeks; good language communication skills, volunteered to participate in this study;
Exclusion Criteria:
- Non-traumatic spinal cord injury (such as bone tumor, spinal cord angiopathy, medical operation, etc.); patients with brain organic diseases; those with definite diagnosis of mental disorders; unwilling to participate in this researcher;
Sites / Locations
- 第四军医大学
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
Active Comparator
Arm Label
Gratitude diary
No intervention
Gratitude visit
Arm Description
Outcomes
Primary Outcome Measures
Gratitude scale (GQ-6) ;
The scale consists of 6 items and is graded at Likert7 level.
Quality of life scale (WHOQOL-BREF) ;
The scale consists of 26 items and 4 dimensions, namely, self-efficacy, resilience, hope and optimism, which are used to measure the level of individual psychological capital, using Likert7 score.
Positive psychological capital scale (PPQ)
The scale consists of 26 items and 4 dimensions, namely, self-efficacy, resilience, hope and optimism, which are used to measure the level of individual psychological capital, using Likert7 score.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04213742
Brief Title
Study on the Application of Gratitude Intervention in Patients With Spinal Cord Injury
Official Title
Study on the Application of Gratitude Intervention in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
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
To analyze the present situation and influencing factors of gratitude level and quality of life of patients with spinal cord injury, and to explore the methods of Thanksgiving intervention for patients with spinal cord injury so as to provide scientific basis for improving the quality of life of patients with spinal cord injury.
Investigation and research design and experimental research design
Detailed Description
Effectiveness evaluation indicators: (1) main efficacy indicators: gratitude level scale (C-GQ-6) score, quality of life scale (WHOQOL-BREF) score; (2) secondary efficacy index: positive psychological capital scale (PPQ) score; trait coping style (TCSQ) score, perceived social support scale (PSSS) score.
Inclusion criteria: accorded with the 6th edition of neurological classification of spinal cord injury issued by the American Spinal Cord injury Society, and confirmed by CT or MRI imaging; sequelae such as limb motor dysfunction caused by spinal cord injury; age ≥ 18 years old; returned to the community after discharge from hospital for at least 2 weeks; good language communication skills, volunteered to participate in this study; Exclusion criteria: spinal cord injury caused by non-trauma (such as bone tumor, spinal cord angiopathy, medical operation, etc.); patients with brain organic diseases; those who were diagnosed with mental disorders; unwilling to participate in this researcher;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients ; Spinal Cord Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gratitude diary
Arm Type
Active Comparator
Arm Title
No intervention
Arm Type
No Intervention
Arm Title
Gratitude visit
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Thanksgiving diary intervention
Intervention Description
Record gratitude.
Primary Outcome Measure Information:
Title
Gratitude scale (GQ-6) ;
Description
The scale consists of 6 items and is graded at Likert7 level.
Time Frame
5 minutes
Title
Quality of life scale (WHOQOL-BREF) ;
Description
The scale consists of 26 items and 4 dimensions, namely, self-efficacy, resilience, hope and optimism, which are used to measure the level of individual psychological capital, using Likert7 score.
Time Frame
5 minutes
Title
Positive psychological capital scale (PPQ)
Description
The scale consists of 26 items and 4 dimensions, namely, self-efficacy, resilience, hope and optimism, which are used to measure the level of individual psychological capital, using Likert7 score.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Conformed to the 6th edition of neurological classification of spinal cord injury issued by the American Spinal Cord injury Society, and confirmed by CT or MRI imaging; sequelae such as different degrees of limb motor dysfunction caused by spinal cord injury; age ≥ 18 years old; returned to the community after discharge from the hospital for at least 2 weeks; good language communication skills, volunteered to participate in this study;
Exclusion Criteria:
Non-traumatic spinal cord injury (such as bone tumor, spinal cord angiopathy, medical operation, etc.); patients with brain organic diseases; those with definite diagnosis of mental disorders; unwilling to participate in this researcher;
Facility Information:
Facility Name
第四军医大学
City
Xian
State/Province
陕西省
ZIP/Postal Code
710000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study on the Application of Gratitude Intervention in Patients With Spinal Cord Injury
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