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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Etimesgut
      • Ankara, Etimesgut, Turkey, 06790
        • Recruiting
        • Baskent University Faculty of Health Sciences
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Video-education
Participants will receive video-education about bypass surgery care, the day before the surgery, for once.
Other: Coronary bypass graft surgery video education
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baskent University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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