Hemodialysis ComplicationNCT06274099
The Effect of the Care Given to Hemodialysis Patients on Comfort Level and Complaints
A study testing nursing care in people with Hemodialysis Complication and Nurse's Role, run by Reva Balci Akpinar at 2 sites in Turkey (Türkiye).
Trial summary
Kolcaba's comfort theory is a theory used by nurses to increase the comfort of patients. There are limited studies determining that nursing care provided according to this theory contributes to the increase in patients' comfort levels in various patient groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Nurse's Role
- What is being tested?
- nursing care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Aug 2024to Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic renal failure Receiving 3 sessions of hemodialysis treatment per week Over 18 years old Must be able to communicate
Who cannot join
- Having a psychiatric illness
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ataturk University
Erzurum, Diğerleri, 25200
REVA BALCI AKPINAR, PROF. DR, +904422312214, reva@atauni.edu.tr
RUKIYE DEMİR DIKMEN
Ataturk University
Erzurum, Diğerleri, 25200
REVA BALCI AKPINAR, PROF. DR, +904422312214, reva@atauni.edu.tr
About this study
Official title: The Effect of Nursing Care Given According to Kolcaba's Comfort Theory on the Complaints and Comfort Level of Hemodialysis Patients
Kolcaba's comfort theory is a theory used by nurses to increase the comfort of patients. There are limited studies determining that nursing care provided according to this theory contributes to the increase in patients' comfort levels in various patient groups. This study will be carried out in the hemodialysis center of a public hospital located in the city center of Bingöl. Patients in the intervention group receiving hemodialysis treatment will be given nursing care by the researcher for 12 sessions during the sessions in which the patient receives hemodialysis treatment. In order to provide nursing care, nursing diagnoses suitable for the patient group will be determined in advance and the care the patient needs will be given according to these diagnoses.. If necessary, the researcher will add additional diagnoses to the preliminary diagnosis form and provide care.
In this research, the individual nursing care needs of the researcher patient will be determined. Individualized caregiving is unique to this study. Individually provided care is expected to increase patient comfort and satisfaction. Increased comfort will help the patient cope more easily with the disease and hemodialysis treatment symptoms. In addition, the results of individual care provided can guide nurses in their care behaviors. By adding this research to the literature, the groundwork will be laid for studies that will provide individual care to patients. It is expected that the results of this research will guide the planning of the research and the provision of individualized care in all patient groups, especially patients receiving hemodialysis treatment.
Read the detailed description
American nurse theorist Katharine Kolcaba developed Comfort Theory based on the care observed or given. Kolcaba has worked in operating room, home care, and medical/surgical specialties. Kolcaba's Comfort Theory; It consists of levels of spaciousness, comfort and superiority (transcendence) and physical, psychospiritual, sociocultural and environmental dimensions. Comfort is an important goal of care that aims to provide the highest quality of life for the patient and their family. Good caregiving, family support, the way of managing information, the search for meaning in life, and the need to control life are important predictors of providing comfort. Patients' physical, sociocultural, psychospiritual and environmental problems affect their comfort. One of the treatment methods used for individuals with chronic kidney failure is Hemodialysis (HD). Living connected to a hemodialysis machine can cause physiological, psychological and social problems in sick individuals. The difficulties that patients face are that they experience physiological problems due to restriction in their nutrition, that they have to restrict fluids, that they live dependent on the treatment team, that they experience psychological problems related to changes in body image, that they experience social problems such as anxiety about the future and limitation of work life, and decreased social relations. These difficulties they experience negatively affect the daily lives and comfort of patients. Comfort is very important for patients receiving hemodialysis treatment. Nurses have important responsibilities in increasing the comfort levels and quality of life of HD patients. It is very important to plan, implement and evaluate nursing interventions .
According to Kolcaba's Comfort Theory, the results of nursing care given to children with cancer have determined that it is an appropriate approach that helps make innovative interventions to provide comfort to children with cancer and allows the patient to be evaluated holistically .
- Conditions
- Hemodialysis Complication, Nurse's Role
- Being tested
- nursing care
- Keywords
- hemodialysis, nursing care, comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing careOther
It is thought that this study, in which individualized care will be based on comfort theory, will lead to individualized care in chronic diseases.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | This group will be given designated nursing care. Receives: Other: nursing care |
| CONTROL GROUP | Active comparator | Routine nursing care will be provided to this group. Receives: Other: nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Comfort Scale
The minimum score that can be obtained from the scale is 48 and the maximum score is 192. As total score increases, comfort increases. A decrease in the score means that the comfort decreases.
Measured: 4 week
Dialysis Symptom Index
The minimum score for the scale is 0 and the maximum score is 150. As the total score approaches 150, the effect of the symptom increases, and as it approaches 0, it indicates that the effect of the symptom decreases.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study startAug 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pretest posttest randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reva Balci Akpinar
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, Reva Balci Akpinar, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274099
- Sponsor's protocol ID
- TDK-2023-12649
- Status last verified
- Jul 2024
- First submitted
- 7 Feb 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baraz S, Zarea K, Dashtbozorgi B. Comparing the effect of two educational programs on the quality of life of hemodialysis patients in iran. Iran Red Crescent Med J. 2014 Aug;16(8):e19368. doi: 10.5812/ircmj.19368. Epub 2014 Aug 5.
PubMed 25389489Borzou SR, Anosheh M, Mohammadi E, Kazemnejad A. Patients' perception of comfort facilitators during hemodialysis procedure: a qualitative study. Iran Red Crescent Med J. 2014 Jul;16(7):e19055. doi: 10.5812/ircmj.19055. Epub 2014 Jul 5.
PubMed 25237587Cabrera VJ, Hansson J, Kliger AS, Finkelstein FO. Symptom Management of the Patient with CKD: The Role of Dialysis. Clin J Am Soc Nephrol. 2017 Apr 3;12(4):687-693. doi: 10.2215/CJN.01650216. Epub 2017 Feb 1.
PubMed 28148557Ebrahimpour F, Hoseini ASS. Suggesting a Practical Theory to Oncology Nurses: Case Report of a Child in Discomfort. J Palliat Care. 2018 Oct;33(4):194-196. doi: 10.1177/0825859718763645. Epub 2018 Mar 21.
PubMed 29560797Kacaroglu Vicdan A. The Effect of Training Given to Hemodialysis Patients According to the Comfort Theory. Clin Nurse Spec. 2020 Jan/Feb;34(1):30-37. doi: 10.1097/NUR.0000000000000495.
PubMed 31789961Moledina DG, Perry Wilson F. Pharmacologic Treatment of Common Symptoms in Dialysis Patients: A Narrative Review. Semin Dial. 2015 Jul-Aug;28(4):377-83. doi: 10.1111/sdi.12378. Epub 2015 Apr 25.
PubMed 25913502Shahdadi H, Rahnama M. Experience of Nurses in Hemodialysis Care: A Phenomenological Study. J Clin Med. 2018 Feb 11;7(2):30. doi: 10.3390/jcm7020030.
PubMed 29439484
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Given According to Kolcaba's Comfort Theory on the Complaints and Comfort Level of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06274099
- Acronym / sponsor ID
- TDK-2023-12649
- Conditions
- Hemodialysis Complication, Nurse's Role
- Keywords
- hemodialysis, nursing care, comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Reva Balci AkpinarUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- Aug 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Feb 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.
Kolcaba's comfort theory is a theory used by nurses to increase the comfort of patients. There are limited studies determining that nursing care provided according to this theory contributes to the increase in patients' comfort levels in various patient groups. This study will be carried out in the hemodialysis center of a public hospital located in the city center of Bingöl. Patients in the intervention group receiving hemodialysis treatment will be given nursing care by the researcher for 12 sessions during the sessions in which the patient receives hemodialysis treatment. In order to provide nursing care, nursing diagnoses suitable for the patient group will be determined in advance and the care the patient needs will be given according to these diagnoses.. If necessary, the researcher will add additional diagnoses to the preliminary diagnosis form and provide care.
In this research, the individual nursing care needs of the researcher patient will be determined. Individualized caregiving is unique to this study. Individually provided care is expected to increase patient comfort and satisfaction. Increased comfort will help the patient cope more easily with the disease and hemodialysis treatment symptoms. In addition, the results of individual care provided can guide nurses in their care behaviors. By adding this research to the literature, the groundwork will be laid for studies that will provide individual care to patients. It is expected that the results of this research will guide the planning of the research and the provision of individualized care in all patient groups, especially patients receiving hemodialysis treatment.
Detailed description
American nurse theorist Katharine Kolcaba developed Comfort Theory based on the care observed or given. Kolcaba has worked in operating room, home care, and medical/surgical specialties. Kolcaba's Comfort Theory; It consists of levels of spaciousness, comfort and superiority (transcendence) and physical, psychospiritual, sociocultural and environmental dimensions. Comfort is an important goal of care that aims to provide the highest quality of life for the patient and their family. Good caregiving, family support, the way of managing information, the search for meaning in life, and the need to control life are important predictors of providing comfort. Patients' physical, sociocultural, psychospiritual and environmental problems affect their comfort. One of the treatment methods used for individuals with chronic kidney failure is Hemodialysis (HD). Living connected to a hemodialysis machine can cause physiological, psychological and social problems in sick individuals. The difficulties that patients face are that they experience physiological problems due to restriction in their nutrition, that they have to restrict fluids, that they live dependent on the treatment team, that they experience psychological problems related to changes in body image, that they experience social problems such as anxiety about the future and limitation of work life, and decreased social relations. These difficulties they experience negatively affect the daily lives and comfort of patients. Comfort is very important for patients receiving hemodialysis treatment. Nurses have important responsibilities in increasing the comfort levels and quality of life of HD patients. It is very important to plan, implement and evaluate nursing interventions .
According to Kolcaba's Comfort Theory, the results of nursing care given to children with cancer have determined that it is an appropriate approach that helps make innovative interventions to provide comfort to children with cancer and allows the patient to be evaluated holistically .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pretest posttest randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Other: nursing careThis group will be given designated nursing care. |
| CONTROL GROUP | Active comparator | Other: nursing careRoutine nursing care will be provided to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic renal failure Receiving 3 sessions of hemodialysis treatment per week Over 18 years old Must be able to communicate
Key exclusion criteria (1 listed)
- Having a psychiatric illness
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 |
|---|---|---|
| nursing careIt is thought that this study, in which individualized care will be based on comfort theory, will lead to individualized care in chronic diseases. | Other | CONTROL GROUP, EXPERIMENTAL GROUP |
Primary outcome
General Comfort Scale
Time frame: 4 week
The minimum score that can be obtained from the scale is 48 and the maximum score is 192. As total score increases, comfort increases. A decrease in the score means that the comfort decreases.
Dialysis Symptom Index
Time frame: 4 week
The minimum score for the scale is 0 and the maximum score is 150. As the total score approaches 150, the effect of the symptom increases, and as it approaches 0, it indicates that the effect of the symptom decreases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 25389489Baraz S, Zarea K, Dashtbozorgi B. Comparing the effect of two educational programs on the quality of life of hemodialysis patients in iran. Iran Red Crescent Med J. 2014 Aug;16(8):e19368. doi: 10.5812/ircmj.19368. Epub 2014 Aug 5.
- Background: PubMed 25237587Borzou SR, Anosheh M, Mohammadi E, Kazemnejad A. Patients' perception of comfort facilitators during hemodialysis procedure: a qualitative study. Iran Red Crescent Med J. 2014 Jul;16(7):e19055. doi: 10.5812/ircmj.19055. Epub 2014 Jul 5.
- Background: PubMed 28148557Cabrera VJ, Hansson J, Kliger AS, Finkelstein FO. Symptom Management of the Patient with CKD: The Role of Dialysis. Clin J Am Soc Nephrol. 2017 Apr 3;12(4):687-693. doi: 10.2215/CJN.01650216. Epub 2017 Feb 1.
- Background: PubMed 29560797Ebrahimpour F, Hoseini ASS. Suggesting a Practical Theory to Oncology Nurses: Case Report of a Child in Discomfort. J Palliat Care. 2018 Oct;33(4):194-196. doi: 10.1177/0825859718763645. Epub 2018 Mar 21.
- Background: PubMed 31789961Kacaroglu Vicdan A. The Effect of Training Given to Hemodialysis Patients According to the Comfort Theory. Clin Nurse Spec. 2020 Jan/Feb;34(1):30-37. doi: 10.1097/NUR.0000000000000495.
- Background: PubMed 25913502Moledina DG, Perry Wilson F. Pharmacologic Treatment of Common Symptoms in Dialysis Patients: A Narrative Review. Semin Dial. 2015 Jul-Aug;28(4):377-83. doi: 10.1111/sdi.12378. Epub 2015 Apr 25.
- Background: PubMed 29439484Shahdadi H, Rahnama M. Experience of Nurses in Hemodialysis Care: A Phenomenological Study. J Clin Med. 2018 Feb 11;7(2):30. doi: 10.3390/jcm7020030.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nursing care in people with Hemodialysis Complication and Nurse's Role, run by Reva Balci Akpinar at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 18 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Comfort Scale (time frame: 4 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274099, which also lists 7 linked publications.
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 18 Jul 2024.