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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06097858
Other study ID # 202212044RIND
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date June 16, 2023

Study information

Verified date October 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To explore the correlations between spiritual well-being, self compassion, physical symptoms distress and demoralization among hemodialysis patients


Description:

The aims of this study is to explore the associations between spiritual well-being, self-compassion, physical symptom distress and demoralization in hemodialysis patients. A cross-sectional correlation design will be used. The investigators use convenient sample to recruit hemodialysis patients in a regional teaching hospital in the southern Taiwan. The research data is collected with a pact of self-administrated questionnaire including Chinese version of the Demoralization Scale , FACIT-Sp-12 Scale, Self-Compassion Scale, and Physical Symptom Distress Scale. SPSS statistical software will be used to data analysis. Analysis methods included descriptive and inferential statistics. Finally, multiple linear regression will be used to test the predictors of demoralization. The research results will offer health providers to identify symptoms related to demoralization earlier and provide appropriate care to patients to adapt the long treatment process and improve their quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date June 16, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - hemodialysis patient who agrees to join this study. - The participant is over 20 years old. - The participant has a clear consciousness and can communicate in Mandarin and Taiwanese to answer the questionnaire. Exclusion Criteria: - The hearing impaired cannot communicate. - Intensive care unit or inpatients. - Mental disorders or dementia such as depression, schizophrenia, and anxiety diagnosed by a physician. - Those who are seriously unwell or have unstable vital signs.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
this is an observation study
no intervention

Locations

Country Name City State
Taiwan NTUH Yunlin Branch Douliu Yunlin

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Clark-Cutaia, M. N., Rivera, E., Iroegbu, C., Arneson, G., Deng, R., & Anastasi, J. K. (2022). Exploring the evidence: symptom burden in chronic kidney disease. Nephrology Nursing Journal, 49(3), 227-255. Costanza, A., Vasileios, C., Ambrosetti, J., Shah,

Outcome

Type Measure Description Time frame Safety issue
Primary The status of spiritual well-being among HD patients Self-administrated questionnaire of The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale-12 was used to collect data. The score range is 0 to 48, and the higher score means higher spiritual well-being. 5 minutes
Primary The status of Self-compassion among HD patients Self-administrated questionnaire of The Self-Compassion Scale-Taiwanese was used to collect data. The score range is 26 to 130, and the higher score means higher level of self-compassion. 5 minutes
Primary The status of Physical Symptoms Distress among HD patients Self-administrated questionnaire of Physical Symptom Distress Scale was used to collect data. The score range is 0 to 64, and the higher score means higher level of physical symptoms distress. 7 minutes
Primary The status of Demoralization among HD patients Self-administrated questionnaire of Demoralization Scale Mandarin Version was used to collect data. The score range is 24 to 120, and the higher score means higher level of demoralization. 6 minutes
Primary the correlations between spiritual well-being, self-compassion, physical symptoms distress and demoralization among HD patients to explore the correlations between these research variables, and to explore the predictors of demoralization 7 minutes
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