The Effect of Pre-anesthetic Education on Cardiac Surgery Patients' Anxiety Level

May 1, 2016 updated by: Arif H. M. Marsaban, Indonesia University

The Effect of Pre-anesthetic Education on Patients' Anxiety Level Undergoing Cardiac Surgery

The study aims to investigate the effect of pre-anesthetic education on patients undergoing cardiac surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects identification was done using identification form, medical record, Mini Mental State Evaluation (MMSE) and Internal Classification of Diseases (ICD) 10. Subjects' anxiety level were measured using Amsterdam Preoperative Anxiety and Information Scale (APAIS) with the help of the researcher to explain the questions. Then, education were given to the subjects, guided by a flow chart made by the researcher, using verbal and emphatic non-verbal language. If during education subjects got anxious with or without cardiovascular emergencies, education would be stopped, subjects would be eased down. Subject's family would be called in. If the subjects agreed to continue, the study would be carried on, otherwise subjects were dropped out. Benzodiazepin and midazolam 0.5 mg/kgBW would be considered and consulted to a psychiatrist. On the day after the education and discussion, subjects filled in APAIS again before entering the operation room. APAIS score recorded before and after anesthesia would be presented in the means, and analyzed by SPSS using paired T-test (or Wilcoxon test as the alternative test).

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged 18-65 years old
  • Subjects able to read and write properly
  • Subjects have adequate communication ability
  • Subjects were able to speak Indonesian language properly
  • Subjects were planned to undergo cardiac surgery
  • Subjects have given informed consent for the anesthetical and surgical procedures.

Exclusion Criteria:

  • Subjects who did not give informed consent
  • Subjects who had done a cardiac surgery before this study commenced,
  • Subjects who had a cognitive/psychiatric problem that decreased communication ability
  • Subjects in antianxiety and/or antidepressant treatment.

Drop out criteria:

  • Subjects who had anxiety sign and symptoms with/without cardiovascular alarming signs and could not be eased down during education
  • Subjects decided to drop out the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects
Pra-anesthetic education given to the subjects includes the anatomy of a normal heart, normal blood circulation, anatomy and pathophysiology of the disease in the respected subject, surgery procedures needed, anesthetic procedures needed for the surgery, and cardiopulmonary bypass procedures. Education and discussion were given repeatedly until subjects could repeat the materials given correctly.
Behavioral: Pre-anesthetic Education
Education was done before the anesthetic procedure, using a flip chart made by the researchers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects' Anxiety Level before Education
Time Frame: 2 months
Subjects' anxiety level before education was measure using APAIS instrument.
2 months
Subjects' Anxiety Level after Education
Time Frame: 2 months
Subjects' anxiety level after education was measure using APAIS instrument.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Arif HM Marsaban, Consultant, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 1, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes002

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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