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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02755909
Enrollment
36
Registered
2016-04-29
Start date
2015-12-31
Completion date
2016-03-31
Last updated
2016-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Patients

Keywords

Cardiac surgery, anxiety, education

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).

Interventions

BEHAVIORALPre-anesthetic Education

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

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Subjects' Anxiety Level before Education2 monthsSubjects' anxiety level before education was measure using APAIS instrument.
Subjects' Anxiety Level after Education2 monthsSubjects' anxiety level after education was measure using APAIS instrument.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026