Study on the Application of Gratitude Intervention in Patients With Spinal Cord Injury

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

Study Overview

• Status: Unknown
• Conditions: Patients ； Spinal Cord Injury
• Intervention / Treatment: Other: Thanksgiving diary intervention

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;

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • 陕西省
    • Xian, 陕西省, China, 710000
      • 第四军医大学

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Active Comparator: Gratitude diary	Other: Thanksgiving diary intervention; Record gratitude.
Active Comparator: Gratitude visit	Other: Thanksgiving diary intervention; Record gratitude.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gratitude scale (GQ-6) ；	The scale consists of 6 items and is graded at Likert7 level.	5 minutes
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.	5 minutes
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.	5 minutes

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: KY20192028-F-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No