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

November 19, 2025 updated by: Ozkan Sir, Yuzuncu Yil University

The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Comfort Levels of Patients Undergoing Open Heart Valve Surgery

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
Patients 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.
Behavioral: Nursing Care Based on Kolcaba's Comfort Theory
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.
Other Names:
  • 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' phy
No Intervention: Control
Control group patients will receive routine nursing care in the ward environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comfort
Time Frame: 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.
To be filled in at 0th and 72nd hours of nursing care.
VAS (Visual Analog Scale) Pain
Time Frame: 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
To be filled in at 0th and 72nd hours of nursing care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yil University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Actual)

April 9, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ataturk Unıversity
  • TDK-2024-14325 (Other Identifier: Ataturk Unıversıty)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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