Clinical trial NCT02755909: The Effect of Pre-anesthetic Education on Cardiac Surgery Patients' Anxiety Level
Official title: The Effect of Pre-anesthetic Education on Patients' Anxiety Level Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery Patients
Keywords: Cardiac surgery, anxiety, education
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Subjects' Anxiety Level before Education
timeFrame: 2 months
measure: Subjects' Anxiety Level after Education
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indonesia University
name: Arif HM Marsaban, Consultant
role: PRINCIPAL_INVESTIGATOR
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