NCT06274099

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

February 7, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

hemodialysisnursing carecomfort

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 week

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

This group will be given designated nursing care.

Other: nursing care

CONTROL GROUP

ACTIVE COMPARATOR

Routine nursing care will be provided to this group.

Other: nursing care

Interventions

It is thought that this study, in which individualized care will be based on comfort theory, will lead to individualized care in chronic diseases.

CONTROL GROUPEXPERIMENTAL GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic renal failure Receiving 3 sessions of hemodialysis treatment per week Over 18 years old Must be able to communicate

You may not qualify if:

  • Having a psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ataturk University

Erzurum, Diğerleri, 25200, Turkey (Türkiye)

Location

Ataturk University

Erzurum, Diğerleri, 25200, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 25389489BACKGROUND
  • 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.

    PMID: 25237587BACKGROUND
  • 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.

    PMID: 28148557BACKGROUND
  • 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.

    PMID: 29560797BACKGROUND
  • 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.

    PMID: 31789961BACKGROUND
  • 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.

    PMID: 25913502BACKGROUND
  • 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.

    PMID: 29439484BACKGROUND

MeSH Terms

Interventions

Nursing Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest posttest randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 23, 2024

Study Start

August 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations