Hemodialysis ComplicationNCT06478446
The Mediating Role of Death Anxiety in Hemodialysis Patients
An observational study of Hemodialysis Complication and Death Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the mediating role of death anxiety in the relationship between religious attitudes and spiritual care needs of hemodialysis (HD) patients in Turkey. The research was designed as a descriptive and cross-sectional study. A total of 203 patients were included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Death Anxiety, Religious Stigmata
- What is being tested?
- observation
- How many people
- 203 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 15 Mar 2024
- 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
- Adult, Older adult
Study population: The data of Burucu and Cantekin (2022) were used to determine the sample size. In this study, it was reported that death anxiety in dialysis patients varied according to the type of dialysis. In the mentioned study, R2 was 0.062 (Burucu \& Cantekin, 2023). According to the multiple regression results on death anxiety, it was determined that the study should be completed with at least 149 participants to achieve 80% power and an effect size of 0.066. According to Dunson and Bollen, Structural Equation Modeling can be adequately performed with small sample sizes (approximately 100) (Palomo, Dunson, \& Bollen, 2007). However, it is recommended that the sample size should be 200 or more (Şen \& Yılmaz, 2013). Therefore, the calculated number was increased by 35% in line with the literature (Yıldırım Kaptanoğlu, 2013) and the sample size of the study was determined as 201. A total of 203 patients were included in the study.
Who may be able to join
- Being eighteen years of age or older
- Being a resident in Turkey
- To be continuing HD treatment
- Not having communication barriers
Who cannot join
- Non-Muslim individuals,
- Those who are in the last stage of the disease,
- Those undergoing cancer treatment
- Those with cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Meram, 42090
About this study
Official title: The Mediating Role of Death Anxiety in the Relationship Between Religious Attitudes and Spiritual Care Needs in Hemodialysis Patients: A Sample of Turkey
This study aimed to determine the mediating role of death anxiety in the relationship between religious attitudes and spiritual care needs of hemodialysis (HD) patients in Turkey. The research was designed as a descriptive and cross-sectional study. A total of 203 patients were included in the study. Descriptive Characteristics Form, Religious Attitude Scale (RAS), Spiritual Care Needs Scale (SCNS), and Death Anxiety Scale (DAS) were used for data collection. In this study, it was found that the indirect effect of religious attitudes on spiritual care needs was significant, and death anxiety mediated the relationship between religious attitudes and spiritual care needs (b= -1.754, 95% CI [-2.95, -0.65]). It can be concluded that death anxiety in HD patients directs individuals towards religious attitudes, and in this case, the need for spiritual care increases. In other words, death anxiety mediates the relationship between religious attitudes and spiritual care needs. Therefore, nurses should include spiritual care when providing nursing care for HD patients.
Read the detailed description
Materials and Methods The research was designed as a descriptive and cross-sectional study. Population and Sample The population of the study consisted of patients undergoing hemodialysis treatment at Necmettin Erbakan University Medical Faculty Hospital.
Sample The data of Burucu and Cantekin (2022) were used to determine the sample size. In this study, it was reported that death anxiety in dialysis patients varied according to the type of dialysis. In the mentioned study, R2 was 0.062. According to the multiple regression results on death anxiety, it was determined that the study should be completed with at least 149 participants to achieve 80% power and an effect size of 0.066. According to Dunson and Bollen, Structural Equation Modeling can be adequately performed with small sample sizes (approximately 100). However, it is recommended that the sample size should be 200 or more. Therefore, the calculated number was increased by 35% in line with the literature and the sample size of the study was determined as 201. A total of 203 patients were included in the study.
Data Collection Tools Descriptive Characteristics Form, Religious Attitude Scale (RAS), Spiritual Care Needs Scale (SCNS), and Death Anxiety Scale (DAS) were used for data collection.
Data were collected face-to-face by the researchers in the hemodialysis (HD) unit. During data collection, protective measures were taken to prevent the risk of infection. The patients were informed about the study and their consent was obtained.
Ethical approval was obtained from the XXX University Health Sciences Scientific Research Ethics Committee, and necessary permissions were obtained from XXX University Medical Faculty Hospital. All stages of the study were completed in accordance with the STROBE checklist and the Declaration of Helsinki.
- Conditions
- Hemodialysis Complication, Death Anxiety, Religious Stigmata
- Being tested
- observation
- Keywords
- Death anxiety, Hemodialysis, Religious attitudes, Renal failure, Spiritual Care Needs
- Medical subject headings
- Necrophobia, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
HD patients were observed and evaluated with three scales.
What is being measured
The primary outcome is the main question the study is designed to answer.
The mediating role of death anxiety on the impact of religious attitudes on spiritual care needs
It was evaluated whether there is a mediating role of death anxiety on the effect of religious attitudes on spiritual care needs
Measured: 2.10.2023/30.02.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start2 Oct 2023
- Primary completion25 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Burucu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478446
- Sponsor's protocol ID
- NECMETTİN EU-
- Status last verified
- Jul 2024
- First submitted
- 22 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Role of Death Anxiety in the Relationship Between Religious Attitudes and Spiritual Care Needs in Hemodialysis Patients: A Sample of Turkey
- ClinicalTrials.gov ID
- NCT06478446
- Acronym / sponsor ID
- NECMETTİN EU-
- Conditions
- Hemodialysis Complication, Death Anxiety, Religious Stigmata
- Keywords
- Death anxiety, Hemodialysis, Religious attitudes, Renal failure, Spiritual Care Needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 27 Jun 2024 (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.
This study aimed to determine the mediating role of death anxiety in the relationship between religious attitudes and spiritual care needs of hemodialysis (HD) patients in Turkey. The research was designed as a descriptive and cross-sectional study. A total of 203 patients were included in the study. Descriptive Characteristics Form, Religious Attitude Scale (RAS), Spiritual Care Needs Scale (SCNS), and Death Anxiety Scale (DAS) were used for data collection. In this study, it was found that the indirect effect of religious attitudes on spiritual care needs was significant, and death anxiety mediated the relationship between religious attitudes and spiritual care needs (b= -1.754, 95% CI [-2.95, -0.65]). It can be concluded that death anxiety in HD patients directs individuals towards religious attitudes, and in this case, the need for spiritual care increases. In other words, death anxiety mediates the relationship between religious attitudes and spiritual care needs. Therefore, nurses should include spiritual care when providing nursing care for HD patients.
Detailed description
Materials and Methods The research was designed as a descriptive and cross-sectional study. Population and Sample The population of the study consisted of patients undergoing hemodialysis treatment at Necmettin Erbakan University Medical Faculty Hospital.
Sample The data of Burucu and Cantekin (2022) were used to determine the sample size. In this study, it was reported that death anxiety in dialysis patients varied according to the type of dialysis. In the mentioned study, R2 was 0.062. According to the multiple regression results on death anxiety, it was determined that the study should be completed with at least 149 participants to achieve 80% power and an effect size of 0.066. According to Dunson and Bollen, Structural Equation Modeling can be adequately performed with small sample sizes (approximately 100). However, it is recommended that the sample size should be 200 or more. Therefore, the calculated number was increased by 35% in line with the literature and the sample size of the study was determined as 201. A total of 203 patients were included in the study.
Data Collection Tools Descriptive Characteristics Form, Religious Attitude Scale (RAS), Spiritual Care Needs Scale (SCNS), and Death Anxiety Scale (DAS) were used for data collection.
Data were collected face-to-face by the researchers in the hemodialysis (HD) unit. During data collection, protective measures were taken to prevent the risk of infection. The patients were informed about the study and their consent was obtained.
Ethical approval was obtained from the XXX University Health Sciences Scientific Research Ethics Committee, and necessary permissions were obtained from XXX University Medical Faculty Hospital. All stages of the study were completed in accordance with the STROBE checklist and the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The data of Burucu and Cantekin (2022) were used to determine the sample size. In this study, it was reported that death anxiety in dialysis patients varied according to the type of dialysis. In the mentioned study, R2 was 0.062 (Burucu \& Cantekin, 2023). According to the multiple regression results on death anxiety, it was determined that the study should be completed with at least 149 participants to achieve 80% power and an effect size of 0.066. According to Dunson and Bollen, Structural Equation Modeling can be adequately performed with small sample sizes (approximately 100) (Palomo, Dunson, \& Bollen, 2007). However, it is recommended that the sample size should be 200 or more (Şen \& Yılmaz, 2013). Therefore, the calculated number was increased by 35% in line with the literature (Yıldırım Kaptanoğlu, 2013) and the sample size of the study was determined as 201. A total of 203 patients were included in the study.
Key inclusion criteria (4 listed)
- Being eighteen years of age or older
- Being a resident in Turkey
- To be continuing HD treatment
- Not having communication barriers
Key exclusion criteria (4 listed)
- Non-Muslim individuals,
- Those who are in the last stage of the disease,
- Those undergoing cancer treatment
- Those with cognitive impairment
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 |
|---|---|---|
| observationHD patients were observed and evaluated with three scales. | Other | – |
Primary outcome
The mediating role of death anxiety on the impact of religious attitudes on spiritual care needs
Time frame: 2.10.2023/30.02.2024
It was evaluated whether there is a mediating role of death anxiety on the effect of religious attitudes on spiritual care needs
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 8 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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 Complication and Death Anxiety, run by Necmettin Erbakan 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 4 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 8 Jul 2024. 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?
The mediating role of death anxiety on the impact of religious attitudes on spiritual care needs (time frame: 2.10.2023/30.02.2024). 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 8 Jul 2024.