Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery
2 other identifiers
interventional
56
1 country
1
Brief Summary
It is planned to determine the effect of comfort theory-based nursing care on the comfort and pain levels of patients undergoing open heart valve surgery.
- Does nursing care based on comfort theory reduce the comfort of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory reduce the pain level of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory increase the comfort level of patients undergoing open heart valve surgery?
- Does nursing care based on comfort theory increase the pain level of patients undergoing open heart valve surgery?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2024
CompletedFirst Submitted
Initial submission to the registry
December 13, 2024
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedNovember 20, 2025
September 1, 2025
6 months
December 13, 2024
November 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
comfort
General Comfort Scale:The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. Low comfort represents one point, and high comfort represents four points. Time frame: To be filled in at 0th and 72nd hours of nursing care.
To be filled in at 0th and 72nd hours of nursing care.
VAS (Visual Analog Scale) Pain
VAS ( Visual analog scale) On a line with '0' on one end and '10' on the other, patients will be asked to choose, explaining that 0 means no symptoms and 10 means the most severe symptoms. A high score here indicates that the patient has high pain during the treatment and care process. Time frame: To be filled in at 0th and 72nd hours of nursing care
To be filled in at 0th and 72nd hours of nursing care
Study Arms (2)
experimental
EXPERIMENTALPatients in the experimental group will receive nursing care based on Kolcaba's Comfort Theory during their stay in the cardiovascular surgery service. After determining the comfort-oriented care needs of the patients, the General Comfort Scale will be used and individualised nursing care plans will be created in line with these needs. According to Kolcaba, standard comfort interventions and comfort interventions provided by coaching will be applied.
Control
NO INTERVENTIONControl group patients will receive routine nursing care in the ward environment.
Interventions
In practice, patient education, pain management, emotional support, appropriate environmental arrangements and individualised care come to the fore. Studies show that with this approach, patients' physical comfort increases, anxiety levels decrease and overall satisfaction improves. It is stated that nursing care based on Kolcaba's theory offers an effective model to improve the quality of life of postoperative patients.
Eligibility Criteria
You may qualify if:
- Volunteering to participate in the study,
- Being 18 years of age or older,
- Being open to communication,
- Not having any obstacle in terms of consciousness and sensory organs,
- Being in the cardiovascular surgery service clinic
You may not qualify if:
- Hearing and/or visual loss
- Leaving the study voluntarily
- Patients transferred from the ward environment back to the intensive care environment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VAN
Erzurum, Van, 25240, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
December 13, 2024
First Posted
January 10, 2025
Study Start
October 9, 2024
Primary Completion
April 9, 2025
Study Completion
July 1, 2025
Last Updated
November 20, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share