HemodialysisNCT05274399
Hopelessness and Self-care Power in Hemodialysis Patients
An observational study of Hemodialysis and Despondency, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the correlation between hopelessness level and self-care agency in patient receiving hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Despondency, Relational Problems
- What is being tested?
- surveys and questionnaires
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2020to 20 Oct 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study consisted of 75 patients registered in the hemodialysis unit of this university hospital, and the sample of the study consisted of 69 patients who were treated in this hospital and voluntarily accepted to participate in the study.
Who may be able to join
- Being 18 years or older,
- To be receiving hemodialysis treatment for at least three months,
- Not having mental confusion or having any psychiatric problems,
- Hearing-sight (except for those who use glasses)-speech problem
- Volunteering to participate in the research
Who cannot join
- Being 18 years or younger,
- have cognitive impairments,
- not being able to complete the questionnaires,
- not wanting to participate in the study,
- having decided to leave the job
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Correlation Between The Hopelessness Level and Self-Care Agency In Patients Receiving Hemodialysis Treatment
The purpose of this study is to investigate the correlation between hopelessness level and self-care agency in patient receiving hemodialysis treatment.
Read the detailed description
While the symptoms and signs that occur as a result of renal failure can be controlled with hemodialysis treatment, the reasons such as the nature of the disease, disease-related symptoms, treatment period and patients' dependency on the hemodialysis machine due to this treatment lead to many physical and psychological problems in the patients. Patients undergoing hemodialysis face physical problems such as becoming dependent, impairment of the socio-economic status, inability to fulfill their role in the society, and changes in work life and various psychological problems such as anxiety, depression, isolation, rejection of the disease, delusions, and hallucinations. it is hoped that this study aiming to determine whether or not there is a correlation between hopelessness level and self-care agency of hemodialysis patients would make a great contribution to the limited available literature.
- Conditions
- Hemodialysis, Despondency, Relational Problems
- Being tested
- surveys and questionnaires
- Keywords
- hemodialysis, hopelessness, self-care agency, nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveys and questionnairesOther
The data containing the questions determining the relationship between the self-care power and hopelessness of the patients who voluntarily participated in the study were collected through a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients | Receiving hemodialysis treatment for at least three months Receives: Other: surveys and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
Age, gender, marital status, educational status, employment status, occupation, income level, family type, disease characteristics; Duration of hemodialysis treatment, presence of other chronic diseases, family history of kidney disease, weekly hemodialysis duration (daytime)
Measured: one week after obtaining permission from the institution
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BUS), to determine the level of pessimism about the future of the individual for the purpose of It consists of 20 items expressed as yes and no.
Measured: one week after obtaining permission from the institution
Self-Care Agency Scale
It consists of 22 items scored between 0-2 in order to evaluate the self-care status of patients receiving long-term dialysis treatment.
Measured: one week after obtaining permission from the institution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start14 Feb 2020
- Primary completion10 May 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihat Demirel, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274399
- Sponsor's protocol ID
- E.1337
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between The Hopelessness Level and Self-Care Agency In Patients Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT05274399
- Acronym / sponsor ID
- E.1337
- Conditions
- Hemodialysis, Despondency, Relational Problems
- Keywords
- hemodialysis, hopelessness, self-care agency, nurse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 10 Mar 2022 (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.
The purpose of this study is to investigate the correlation between hopelessness level and self-care agency in patient receiving hemodialysis treatment.
Detailed description
While the symptoms and signs that occur as a result of renal failure can be controlled with hemodialysis treatment, the reasons such as the nature of the disease, disease-related symptoms, treatment period and patients' dependency on the hemodialysis machine due to this treatment lead to many physical and psychological problems in the patients. Patients undergoing hemodialysis face physical problems such as becoming dependent, impairment of the socio-economic status, inability to fulfill their role in the society, and changes in work life and various psychological problems such as anxiety, depression, isolation, rejection of the disease, delusions, and hallucinations. it is hoped that this study aiming to determine whether or not there is a correlation between hopelessness level and self-care agency of hemodialysis patients would make a great contribution to the limited available literature.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients | – | Other: surveys and questionnairesReceiving hemodialysis treatment for at least three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consisted of 75 patients registered in the hemodialysis unit of this university hospital, and the sample of the study consisted of 69 patients who were treated in this hospital and voluntarily accepted to participate in the study.
Key inclusion criteria (5 listed)
- Being 18 years or older,
- To be receiving hemodialysis treatment for at least three months,
- Not having mental confusion or having any psychiatric problems,
- Hearing-sight (except for those who use glasses)-speech problem
- Volunteering to participate in the research
Key exclusion criteria (5 listed)
- Being 18 years or younger,
- have cognitive impairments,
- not being able to complete the questionnaires,
- not wanting to participate in the study,
- having decided to leave the job
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveys and questionnairesThe data containing the questions determining the relationship between the self-care power and hopelessness of the patients who voluntarily participated in the study were collected through a questionnaire. | Other | Hemodialysis Patients |
Primary outcome
Patient Information Form
Time frame: one week after obtaining permission from the institution
Age, gender, marital status, educational status, employment status, occupation, income level, family type, disease characteristics; Duration of hemodialysis treatment, presence of other chronic diseases, family history of kidney disease, weekly hemodialysis duration (daytime)
Beck Hopelessness Scale (BHS)
Time frame: one week after obtaining permission from the institution
Beck Hopelessness Scale (BUS), to determine the level of pessimism about the future of the individual for the purpose of It consists of 20 items expressed as yes and no.
Self-Care Agency Scale
Time frame: one week after obtaining permission from the institution
It consists of 22 items scored between 0-2 in order to evaluate the self-care status of patients receiving long-term dialysis treatment.
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 28 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemodialysis and Despondency, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 28 Mar 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 Turkey (Türkiye). 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?
Patient Information Form (time frame: one week after obtaining permission from the institution). The study lists 3 primary outcomes in all. 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 28 Mar 2023.