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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06098924
Other study ID # NSCT-112-2014-H-255-009
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 10, 2023
Est. completion date July 31, 2024

Study information

Verified date October 2023
Source Chang Gung University of Science and Technology
Contact yachu hsiao, EdD
Phone 0939740890
Email yjshiao@mail.cgust.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to verify the mediating effect of life of meaning and post-traumatic growth in spirituality and psychological well-being (happiness, depression).


Description:

The research design is cross-sectional correlational study. Convenient sampling will be used to conduct to data collection. There are 300 patients with hemodialysis from a hemodialysis institution in the north Taiwan, and data collecting with self-administrated questionnaires. The instruments include demographic and disease-related information, Spiritual Health Scale short form, Chinese Happiness Inventory, Beck Depression Inventory-II, Life Attitude Profile, Posttraumatic Growth Inventory. The SPSS 22.0 statistical software will be used to analyze the data. Descriptive statistics, such as frequency, percentage, mean, and standard deviation (SD) will be used for participant characteristics and outcome measures. T-test, chi-square, ANOVA, post-hoc, ANCOVA, and Person's correlation will be conducted to test the relationships between the research variables.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - Patients who are over 20 years old - voluntarily participate in the study and sign the respondent consent form - have received routine hemodialysis treatment for more than three months - have clear consciousness and can communicate in Mandarin and Taiwanese. Exclusion Criteria: - Patients whose medical records record a diagnosis of schizophrenia - patients are taking antidepressant drugs

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Chang Gung University of Science and Technology Taoyuan City N/A = Not Applicable

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University of Science and Technology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The status of spirituality among HD patients Self-administrated questionnaire of Spiritual Health Scale short form was used to collect data. The score range is 24 to 120, and the higher score means higher spirituality. 1 day
Primary The status of life-meaning among HD patients Self-administrated questionnaire of Life Attitude Profile was used to collect data. The score range is 39 to 195, and the higher score means higher level of life-meaning. 1 day
Primary The status of post-trauma growth among HD patients Self-administrated questionnaire of Posttraumatic Growth Inventory was used to collect data. The score range is 0 to 105, and the higher score means higher level of post-trauma growth. 1 day
Primary The status of depression among HD patients Self-administrated questionnaire of Beck Depression Inventory-II was used to collect data. The score range is 0 to 63, and the higher score means higher level of depressive tendency. 7 minutes
Primary The status of happiness among HD patients Self-administrated questionnaire of Chinese Happiness Inventory was used to collect data. The score range is 0 to 30, and the higher score means higher level of happiness. 1 day
Primary The mediating effect of life of meaning and post-traumatic growth Using these scores form these scales (mention above) to verify the mediating effect of life of meaning and post-traumatic growth in spirituality and psychological well-being (including happiness, depression). 1 day
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