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

NCT ID: NCT02755909

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-03-31

Brief Summary

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

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).

Conditions

Cardiac Surgery Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Pre-anesthetic Education

Intervention Type: BEHAVIORAL

Education was done before the anesthetic procedure, using a flip chart made by the researchers.

Interventions

Pre-anesthetic Education

Education was done before the anesthetic procedure, using a flip chart made by the researchers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Arif H. M. Marsaban

Consultant, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arif HM Marsaban, Consultant

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

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Other Identifiers

IndonesiaUAnes002

Identifier Type: -

Identifier Source: org_study_id