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

NCT ID: NCT06769945

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2025-07-01

Brief Summary

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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

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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.

Conditions

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Surgery (Cardiac)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Nursing Care Based on Kolcaba's Comfort Theory

Intervention Type 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.

Control

Control group patients will receive routine nursing care in the ward environment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuzuncu Yil University

OTHER

Sponsor Role lead

Responsible Party

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Ozkan Sir

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VAN

Erzurum, Van, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TDK-2024-14325

Identifier Type: OTHER

Identifier Source: secondary_id

Ataturk Unıversity

Identifier Type: -

Identifier Source: org_study_id

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