NCT06174974

Brief Summary

Aim of the Thesis and Hypotheses: (The aim of the thesis and hypotheses should be stated in detail.) In this study, it was aimed to determine the effect of the education given to the patients before cardiac surgery on the environmental stressors perceived by the patients in the intensive care unit. H1: The education given before heart surgery has an effect on the environmental stressors perceived by patients in the intensive care unit. H2: The education given before cardiac surgery has no effect on the environmental stressors perceived by patients in the intensive care unit.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

November 27, 2023

Last Update Submit

December 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • environmental stressors perceived by patients

    To determine the effect of education given before cardiac surgery on environmental stressors perceived by patients in the intensive care unit."Intensive Care Unit Environmental Stressors Scale" will be applied on the day the patients are transferred to the ward. The 4-Likert type scale consists of 42 items. The items evaluated as "It does not affect at all (1 point) ", "It affects very little (2 points)", "It frequently affects (3 points)" and "It affects too much (4 points)". The lowest total score is 42 and the highest total score is 168. The high score obtained from the scale indicates that there are many environmental stressors in the intensive care environment, and they negatively affect the patients.

    Patients transferred from the cardiovascular surgery intensive care unit to the cardiovascular surgery service, on the day of transfer (postoperative 2-3rd day).

Secondary Outcomes (1)

  • patients' satisfaction

    postoperative period (postoperative 2nd or 3rd day)

Study Arms (2)

Experimental group

EXPERIMENTAL

The patients in the experimental group will be informed by the researcher in the training room in the ward 1 day before the operation (verbal permission was obtained) with an educational presentation on intensive care unit stressors.

Other: Education

Control group

NO INTERVENTION

Patients in the control group will not be given preoperative training on intensive care unit stressors by the researcher. Patients in the control group will receive standard care\*.

Interventions

The education was designed to cover the environmental stressors of the intensive care unit and the practices performed to reduce these stressors. The education content was created according to the Activities of Daily Living (ADL) Theory based on the institution's cardiovascular surgical intensive care unit protocols (Cardiovascular surgical intensive care unit visitor entry-exit rules information form) and the literature (included at the end of the presentation). Expert (intensive care nurses, ward nurses, cardiovascular surgeons and academic nurses) opinions were obtained. Patient-friendly and simple language was used to ensure that the content of the information presentation was acceptable and interesting.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Inpatient treatment in the cardiovascular surgery ward prior to surgery,
  • Undergoing planned cardiac surgery under general anaesthesia,
  • Admitted to the cardiovascular surgery intensive care unit after surgery,
  • At least 24 hours in the intensive care unit,
  • Sternotomy performed,
  • who volunteered to participate in the research,
  • No mental disability,
  • years of age,
  • Literate,
  • Accepting random selection,
  • Patients without communication problems in Turkish

You may not qualify if:

  • Treated as a day patient in the cardiovascular surgery ward,
  • Pre-operative inpatient treatment in cardiology, coronary intensive care or other external wards,
  • Without sternotomy,
  • Admitted to intensive care or external ward after surgery,
  • Emergency surgery,
  • Not volunteering to participate in the research,
  • Mentally handicapped,
  • Under 18 years of age,
  • Illiterate,
  • which does not accept random selection,
  • Patients with communication problems in Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Trakya University

Edirne, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

ZEYNEP KIZILCIK ÖZKAN, PhD

CONTACT

Gökben OSMANLI KARBUZ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data will be collected and coded by the nurse researcher. Data will be analyzed by an independent statistician. The study groups will be disguised as A and B. The statistician will not know the groups. In addition, the statistical expert will not see the data of the experimental group regarding satisfaction.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The patients in the experimental group will be informed by the researcher in the training room in the ward 1 day before the operation (verbal permission was obtained) with an educational presentation on intensive care unit stressors. Patients in the control group will not be given preoperative training on intensive care unit stressors by the researcher. Patients in the control group will receive standard care\*.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 18, 2023

Study Start

December 1, 2023

Primary Completion

March 31, 2024

Study Completion

August 31, 2024

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations