Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06769945
Enrollment
56
Registered
2025-01-10
Start date
2024-10-09
Completion date
2025-07-01
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery (Cardiac)

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.

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.

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
comfortTo 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) PainTo be filled in at 0th and 72nd hours of nursing careVAS ( 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026