NCT06769945

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

December 13, 2024

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • comfort

    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

    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

Study Arms (2)

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

Control

NO INTERVENTION

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

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.

Also known as: 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
experimental

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hearing and/or visual loss
  • Leaving the study voluntarily
  • Patients transferred from the ward environment back to the intensive care environment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VAN

Erzurum, Van, 25240, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Patient Education as TopicPain Management

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesTherapeuticsDisease ManagementPatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 13, 2024

First Posted

January 10, 2025

Study Start

October 9, 2024

Primary Completion

April 9, 2025

Study Completion

July 1, 2025

Last Updated

November 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations