Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery

Not Applicable

Not yet recruiting

• Conditions: Surgery (Cardiac)

• Registration Number: NCT06769945
• Lead Sponsor: Yuzuncu Yıl University

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?

Detailed Description

Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping the individual with his/her needs, providing peace of mind and being able to overcome problems." In his theory, Kolcaba defined comfort as "an expected result with a complex structure within the physical, psychospiritual, social and environmental integrity of helping the individual with his needs, providing peace of mind and overcoming problems. This situation affects recovery and discharge times. Studies indicate that comfort is one of the most important factors affecting the speed of recovery. The sample size of the study was determined using power analysis. As a result of the Power analysis (G\*Power 3.1.9.4); when the effect size was taken as Cohen's d: 0.95, the number of samples determined for a confidence interval of 95%, a power of 95%, and a margin of error of 0.05 was determined as a total of 50 patients, with a minimum of 25 patients for each group (Experimental and Control). Considering the block randomization distributions, the study was completed with 56 patients.

Study Timeline

• Study First Submitted: 2024-12-13
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-02-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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

Exclusion Criteria

• Hearing and/or visual loss
• Leaving the study voluntarily
• Patients transferred from the ward environment back to the intensive care environment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
comfort	To be filled in at 0th and 72nd hours of nursing care.	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.
VAS (Visual Analog Scale) Pain	To be filled in at 0th and 72nd hours of nursing care	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