NCT06174090

Brief Summary

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.

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
46

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable coronary-artery-disease

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

Study Start

First participant enrolled

September 5, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 8, 2023

Last Update Submit

December 8, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain Level

    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

    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

    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

Study Arms (2)

Video-education

EXPERIMENTAL

Participants will receive video-education about bypass surgery care, the day before the surgery, for once.

Other: Coronary bypass graft surgery video education

Control

NO INTERVENTION

Participants will receive verbal education about bypass surgery care, the day before the surgery, once

Interventions

It includes information about surgical process and handling issues within the first few days of surgery.

Video-education

Eligibility Criteria

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

You may qualify if:

  • 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"

You may not qualify if:

  • Patients with visual or hearing impariment
  • Patients with psychiatric illness,
  • Patients with known cognitive impairment (dementia, Alzheimer's).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Faculty of Health Sciences

Ankara, Etimesgut, 06790, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Gülçin Şahin, MSc

CONTACT

Nalan Özhan Elbaş, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The intervention group will watch a 12-minute video-education about pre-post surgical process and care in bypass surgery, for once the day before surgery. Video-education was created by the researcher based on the literature. Expert opinion was provided related to content. The control group will receive standard verbal education lasting 12-minute about the issue.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MSc

Study Record Dates

First Submitted

December 8, 2023

First Posted

December 18, 2023

Study Start

September 5, 2023

Primary Completion

January 31, 2024

Study Completion

March 31, 2024

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

There is no plan for sharing IPD unless it is requested for a reasonable cause.

Locations