Clinical trial NCT06769945: Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery (Cardiac)
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: comfort
timeFrame: To be filled in at 0th and 72nd hours of nursing care.
measure: VAS (Visual Analog Scale) Pain
timeFrame: To be filled in at 0th and 72nd hours of nursing care
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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