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Completed

NCT Number: NCT06769945

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?

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VAN

Erzurum, Van, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nursing Care Based on Kolcaba's Comfort Theory

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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