- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06174090
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
December 8, 2023 updated by: Gulcin Sahin, Baskent University
The Effect of Patient Education With Video Prior to Coronary Artery Bypass Graft Surgery on Pain, Anxiety and Knowledge Levels of Patients
The aim of this research to examine the effectiveness of video-education on pain, anxiety, and knowledge levels on adult patients undergoing coronary artery bypass graft surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A video based patient education will be used in this randomized controlled study.
Patient education via video aims to reduce the patient's anxiety levels, control their pain, and improve their health outcomes by increasing knowledge levels.
In addition, since this training is visual-based, it is aimed to provide effective learning by reducing the inequality due to sociodemographic and individual differences between participants.
The video-education includes information about pre and post-surgical process and care.
Study Type
Interventional
Enrollment (Estimated)
46
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 Contact
- Name: Gülçin Şahin, MSc
- Phone Number: +905319901871
- Email: gulcinnn.sahin@gmail.com
Study Contact Backup
- Name: Nalan Özhan Elbaş, Prof.
- Phone Number: 1596 +903122466666
- Email: nelbas@baskent.edu.tr
Study Locations
-
-
Etimesgut
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Ankara, Etimesgut, Turkey, 06790
- Recruiting
- Baskent University Faculty of Health Sciences
-
Contact:
- Nalan Özhan Elbaş, Prof.
- Phone Number: 1596 +903122466666
- Email: nelbas@baskent.edu.tr
-
Contact:
- Gülçin Şahin, MSc, RN
- Phone Number: +905319901871
- Email: gulcinnn.sahin@gmail.com
-
-
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
No
Description
Inclusion Criteria:
- Being at least 18 years old
- Being hospitalized in Cardiovascular Surgery Clinic and Cardiovascular surgery intensive care unit
- Undergoing coronary artery bypass graft surgery for the first time, by sternotomy method
- Patients who agree to participate in the research and read and sign the "Informed Volunteer Consent Form for Scientific Research"
Exclusion Criteria:
- Patients with visual or hearing impariment
- Patients with psychiatric illness,
- Patients with known cognitive impairment (dementia, Alzheimer's).
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video-education
Participants will receive video-education about bypass surgery care, the day before the surgery, for once.
|
It includes information about surgical process and handling issues within the first few days of surgery.
|
No Intervention: Control
Participants will receive verbal education about bypass surgery care, the day before the surgery, once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Level
Time Frame: from 24th of surgery to 72nd hour
|
Visual analog scale (VAS): VAS is a widely used scale for pain assessment.
The scale was developed by Albersnagel, and its validity and reliability in our country were established by Aydin et al.
In VAS, pain averages ranging from 0 to 10 are given on a 10 cm scale.
Accordingly, while "0" indicates no pain, an average VAS value of "1-4" indicates mild pain, "5-6" indicates moderate pain, and "7-10" indicates severe.
Change= VAS score of video-education group<standard verbal education.on
24th, 48th, and 72nd hours after surgery
|
from 24th of surgery to 72nd hour
|
Anxiety level
Time Frame: from baseline prior to education to 72nd hour of surgery
|
State anxiety scale (STAI-I): The scale determines how the individual feels at a certain moment, in a certain condition, and his/her emotions regarding the situation.
The total score obtained from the scale is between 20-80.
A high score indicates a high level of anxiety.
The feelings and behaviors expressed in the State Anxiety Scale items are answered by marking one of the following conditions, such as (1) not at all, (2) a little, (3) a lot and (4) completely, according to the severity of such experiences.
Change= STAI-I score of video-education group<standard verbal education.on
pre-and-post education, and on 72nd hours after surgery.
|
from baseline prior to education to 72nd hour of surgery
|
Preoperative anxiety
Time Frame: from baseline prior to education to 72nd hour of surgery
|
Amsterdam Preoperative Anxiety and Information Scale (APAIS): The scale is one of the scales used to evaluate preoperative anxiety.
Source of anxiety; It is divided into three: due to surgery, anesthesia or lack of information.
It contains 6 statements regarding these three sources to assess anxiety.
In order to objectify the survey, each statement is given a numerical value based on a 5-point Likert scale according to severity; These values, ranging from 1 to 5; 1=none, 2=mild, 3=moderate, 4=severe, 5=extreme severity.
Higher score means higher preoperative anxiety.
Change= APAIS score of video-education group<standard verbal education n pre-and-post education, and on 72nd hours after surgery.
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from baseline prior to education to 72nd hour of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 5, 2023
Primary Completion (Estimated)
January 31, 2024
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
December 8, 2023
First Submitted That Met QC Criteria
December 8, 2023
First Posted (Estimated)
December 18, 2023
Study Record Updates
Last Update Posted (Estimated)
December 18, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA21/131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan for sharing IPD unless it is requested for a reasonable cause.
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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