DemoralizationNCT05841459
Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among HD Patients
An observational study of Demoralization, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
To explore the associations between spiritual well-being, self-compassion, physical symptoms distress and demoralization among hemodialysis patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Demoralization
- How many people
- 156 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2023to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hemodialysis patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung University of Science and Technology
Taoyuan City, N/A = Not Applicable, 333 03
About this study
Official title: Study of Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among Hemodialysis Patients
To explore the associations between spiritual well-being, self-compassion, physical symptoms distress and demoralization among hemodialysis patients
Read the detailed 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. We 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 , FACITsp-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
- Conditions
- Demoralization
- Keywords
- spirituality, self-compassion, demoralization
What is being measured
The primary outcome is the main question the study is designed to answer.
demoralization
The demoralization scale is a validated multidimensional measure that assesses patients' status of demoralization
Measured: during the procedure
Secondary outcomes (3)
spiritual well-being
The spiritual well-being scale is a validated multidimensional measure that assesses patients' spirituality
Measured: during the procedure
self compassion
The self-compassion scale is a validated multidimensional measure that assesses patients' level of self-compassion
Measured: during the procedure
physical symptom distress
The physical symptom distress scale is a validated multidimensional measure that assesses patients' level of physical symptom distress
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Feb 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DemoralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Chu Hsiao, Chang Gung University of Science and Technology
- Investigators
- Ya-Chu Hsiao, EdD, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841459
- Sponsor's protocol ID
- 202212044RIND
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05841459
- Acronym / sponsor ID
- 202212044RIND
- Conditions
- Demoralization
- Keywords
- spirituality, self-compassion, demoralization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the associations between spiritual well-being, self-compassion, physical symptoms distress and demoralization among hemodialysis patients
Detailed 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. We 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 , FACITsp-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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
demoralization
Time frame: during the procedure
The demoralization scale is a validated multidimensional measure that assesses patients' status of demoralization
3 secondary outcomes
spiritual well-being
Time frame: during the procedure
self compassion
Time frame: during the procedure
physical symptom distress
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
Related trials for Demoralization
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MB-PAT for Demoralization in Advanced Cancer ('PAT-MIND') Trial
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Lysergic Acid Diethylamide (LSD) in Palliative Care
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Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer
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Existential Distress in Advanced Cancer: Comparing a Short-term Psychodynamic Psychotherapy (ORPHYS) to Treatment as Usual (TAU)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Chu Hsiao, EdD principal investigator
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Demoralization, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demoralization (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.