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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04213742
Other study ID # KY20192028-F-2
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 2, 2019
Est. completion date June 30, 2020

Study information

Verified date December 2019
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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;


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 400
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
Thanksgiving diary intervention
Record gratitude.

Locations

Country Name City State
China ?????? Xian ???

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gratitude scale (GQ-6) ; The scale consists of 6 items and is graded at Likert7 level. 5 minutes
Primary 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
Primary 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