- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274099
The Effect of the Care Given to Hemodialysis Patients on Comfort Level and Complaints
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.
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Diğerleri
-
Erzurum, Diğerleri, Turkey, 25200
- Ataturk University
-
Contact:
- REVA BALCI AKPINAR, PROF. DR
- Phone Number: +904422312214
- Email: reva@atauni.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
Clinical diagnosis of chronic renal failure Receiving 3 sessions of hemodialysis treatment per week Over 18 years old Must be able to communicate
Exclusion Criteria:
Having a psychiatric illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EXPERIMENTAL GROUP
This group will be given designated nursing care.
|
It is thought that this study, in which individualized care will be based on comfort theory, will lead to individualized care in chronic diseases.
|
|
Active Comparator: CONTROL GROUP
Routine nursing care will be provided to this group.
|
It is thought that this study, in which individualized care will be based on comfort theory, will lead to individualized care in chronic diseases.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 week
|
|
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.
|
4 week
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Borzou 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.
- Cabrera 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.
- Ebrahimpour 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.
- Kacaroglu 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.
- Moledina 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.
- Shahdadi 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TDK-2023-12649
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemodialysis Complication
-
National Taiwan University HospitalCompletedHemodialysis Complication | Hemodialysis-Induced SymptomTaiwan
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedHemodialysis ComplicationTurkey (Türkiye)
-
Kafkas UniversityEnrolling by invitationHemodialysis ComplicationTurkey (Türkiye)
-
Saint-Joseph UniversityTerminated
-
Fresenius Kabi Taiwan Ltd.Chung Shan Medical UniversityCompleted
-
Assiut UniversityNot yet recruitingHemodialysis Complication
-
RenJi HospitalNot yet recruitingHemodialysis Complication
-
China Medical University HospitalMinistry of Science and Technology, TaiwanTerminated
-
Cairo UniversityCompletedHemodialysis ComplicationEgypt
-
Muş Alparlan UniversityCompletedHemodialysis ComplicationTurkey
Clinical Trials on nursing care
-
IRCCS Centro Neurolesi Bonino PulejoCompleted
-
Mehtap GümüşayCompletedQuality of Life | Nursing Caries | Surgical MenopauseTurkey
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Completed
-
Chung Shan Medical UniversityCompletedCancer Patients | Radiation Therapy | TattooingTaiwan
-
French Society for Intensive CareCompletedCritical Care | Nursing CariesFrance, Switzerland, Belgium, Luxembourg
-
Ataturk UniversityNot yet recruitingKnee ArthroplastyTurkey (Türkiye)
-
Second Affiliated Hospital, School of Medicine,...Unknown
-
Hacettepe UniversityCompletedImplantable Cardioverter-defibrillators (ICDs)Turkey (Türkiye)
-
Shanxi Province Cancer HospitalCompletedLung Neoplasms | Small Cell Lung Cancer | Extensive-Stage Small Cell Lung CancerChina
-
Tokat Gaziosmanpasa UniversityAnkara City Hospital BilkentEnrolling by invitationNursing Caries | Self Confidence | Newborn | AttachmentTurkey