End of LifeNCT06515847
Comfort and Quality of Life of Patients at the End of Life
A study testing End of Life Nursing Care Plan in people with End of Life, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
A Research to Evaluate the Effect of Nursing Care Practices Based on Kolcaba's Comfort Theory on the Comfort Levels and Quality of Life of End-of-Life Patients. Purpose: The study was carried out as a semi-experimental posttest with independent groups and a control group, in order to determine the effect of nursing… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- End of Life
- What is being tested?
- End of Life Nursing Care Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 1 Sep 2018
- Phase
- Interventional
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 25-70 years old,
- communicable,
- at least primary school graduates,
- hospitalized in the unit for at least 2 weeks, and who agreed to participate in the study were included in the study.
Who cannot join
- All patients who did not meet the inclusion criteria and patients who were included in the study but died within 2 weeks were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate The Effects Of Nursing Care İmplementations Based On Kolcaba's Comfort Theory For The End Of Life Patients Comfort Levels and The Life Quality
A Research to Evaluate the Effect of Nursing Care Practices Based on Kolcaba's Comfort Theory on the Comfort Levels and Quality of Life of End-of-Life Patients.
Purpose: The study was carried out as a semi-experimental posttest with independent groups and a control group, in order to determine the effect of nursing care interventions on the patient's quality of life comfort level, based on Kolcaba's comfort theory. end-of-life patients.
Materials and Methods: This study compared 30 experimental and 30 control patients, aged between 25-70, at least primary school graduate, staying in the palliative care unit. He used the unit for at least two weeks and agreed to be part of this study. While the patients in the experimental group were cared for according to the nursing care plan based on Kolcaba's comfort theory, the patients in the control group were treated with the institution's standard care plan. The results were evaluated according to the standard comfort scale and the general quality of life scale.
- Conditions
- End of Life
- Being tested
- End of Life Nursing Care Plan
- Keywords
- Comfort, nurse, care
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End of Life Nursing Care PlanOther
the patients of experimental group were cared according to the nursing care plan based on Kolcaba's comfort theory,
| Study group | Role | What they receive |
|---|---|---|
| Kolcaba's nursing care plan | Experimental | While the patients of experimental group were cared according to the nursing care plan based on Kolcaba's comfort theory, Receives: Other: End of Life Nursing Care Plan |
| standard care plan | No intervention | the patients of control group received the standard care plan of the institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kolcaba's comfort theory
The general comfort scale scores of patients who are cared for according to the care plan prepared according to Kolcaba's comfort theory will be higher than the control group.
The scale was developed by Kolcaba in 2006. Comfort includes the subscales of relief (9 items), relaxation (9 items) and overcoming problems (10 items). In evaluating the scale consisting of positive and negative items, negative items are reverse coded and summed. The average value is found by dividing the total score obtained by the number of scale items. The lowest possible value of 1 indicates low comfort, and the highest value of 6 indicates high comfort.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Sep 2017
- Primary completion1 Sep 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of LifeStudies of the same condition, open and under way.
- More trials run by Fenerbahce 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadriye Nilay Genc, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515847
- Sponsor's protocol ID
- 2016.235.IRB2.117
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will not be used for research by other researchers. It is specific to this study. Patient data will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate The Effects Of Nursing Care İmplementations Based On Kolcaba's Comfort Theory For The End Of Life Patients Comfort Levels and The Life Quality
- ClinicalTrials.gov ID
- NCT06515847
- Acronym / sponsor ID
- 2016.235.IRB2.117
- Conditions
- End of Life
- Keywords
- Comfort, nurse, care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 23 Jul 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.
A Research to Evaluate the Effect of Nursing Care Practices Based on Kolcaba's Comfort Theory on the Comfort Levels and Quality of Life of End-of-Life Patients.
Purpose: The study was carried out as a semi-experimental posttest with independent groups and a control group, in order to determine the effect of nursing care interventions on the patient's quality of life comfort level, based on Kolcaba's comfort theory. end-of-life patients.
Materials and Methods: This study compared 30 experimental and 30 control patients, aged between 25-70, at least primary school graduate, staying in the palliative care unit. He used the unit for at least two weeks and agreed to be part of this study. While the patients in the experimental group were cared for according to the nursing care plan based on Kolcaba's comfort theory, the patients in the control group were treated with the institution's standard care plan. The results were evaluated according to the standard comfort scale and the general quality of life scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental study
| Arm | Type | Receives |
|---|---|---|
| Kolcaba's nursing care plan | Experimental | Other: End of Life Nursing Care PlanWhile the patients of experimental group were cared according to the nursing care plan based on Kolcaba's comfort theory, |
| standard care plan | No intervention | –the patients of control group received the standard care plan of the institution |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 25-70 years old,
- communicable,
- at least primary school graduates,
- hospitalized in the unit for at least 2 weeks, and who agreed to participate in the study were included in the study.
Key exclusion criteria (1 listed)
- All patients who did not meet the inclusion criteria and patients who were included in the study but died within 2 weeks were excluded from the study.
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 |
|---|---|---|
| End of Life Nursing Care Planthe patients of experimental group were cared according to the nursing care plan based on Kolcaba's comfort theory, | Other | Kolcaba's nursing care plan |
Primary outcome
Kolcaba's comfort theory
Time frame: 2 week
The general comfort scale scores of patients who are cared for according to the care plan prepared according to Kolcaba's comfort theory will be higher than the control group. The scale was developed by Kolcaba in 2006. Comfort includes the subscales of relief (9 items), relaxation (9 items) and overcoming problems (10 items). In evaluating the scale consisting of positive and negative items, negative items are reverse coded and summed. The average value is found by dividing the total score obtained by the number of scale items. The lowest possible value of 1 indicates low comfort, and the highest value of 6 indicates high comfort.
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 23 Jul 2024.
- Individual participant dataSharing planned: No. Study data will not be used for research by other researchers. It is specific to this study. Patient data will be kept confidential.
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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?
A study testing End of Life Nursing Care Plan in people with End of Life, run by Fenerbahce 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 1 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 23 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?
Kolcaba's comfort theory (time frame: 2 week). 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 23 Jul 2024.