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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02755909
Other study ID # IndonesiaUAnes002
Secondary ID
Status Completed
Phase N/A
First received April 28, 2016
Last updated May 1, 2016
Start date December 2015
Est. completion date March 2016

Study information

Verified date May 2016
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority Indonesia: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

References & Publications (12)

Bensing J. Doctor-patient communication and the quality of care. Soc Sci Med. 1991;32(11):1301-10. — View Citation

Bonnet C, Greffier A. Paediatric cardiac catheterization: an information sheet. Arch Cardiovasc Dis. 2013 Apr;106(4):228-37. doi: 10.1016/j.acvd.2013.01.007. Epub 2013 Apr 23. Review. — View Citation

Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7. — View Citation

Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S467-72. doi: 10.1002/acr.20561. Review. — View Citation

Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. — View Citation

Kiyohara LY, Kayano LK, Oliveira LM, Yamamoto MU, Inagaki MM, Ogawa NY, Gonzales PE, Mandelbaum R, Okubo ST, Watanuki T, Vieira JE. Surgery information reduces anxiety in the pre-operative period. Rev Hosp Clin Fac Med Sao Paulo. 2004 Apr;59(2):51-6. Epub 2004 Apr 26. — View Citation

Laufenberg-Feldmann R, Kappis B. Assessing preoperative anxiety using a questionnaire and clinical rating: a prospective observational study. Eur J Anaesthesiol. 2013 Dec;30(12):758-63. doi: 10.1097/EJA.0b013e3283631751. — View Citation

Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. — View Citation

Millar K, Jelicic M, Bonke B, Asbury AJ. Assessment of preoperative anxiety: comparison of measures in patients awaiting surgery for breast cancer. Br J Anaesth. 1995 Feb;74(2):180-3. — View Citation

Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. — View Citation

Valenzuela Millán J, Barrera Serrano JR, Ornelas Aguirre JM. Anxiety in preoperative anesthetic procedures. Cir Cir. 2010 Mar-Apr;78(2):147-51. English, Spanish. — View Citation

Wetsch WA, Pircher I, Lederer W, Kinzl JF, Traweger C, Heinz-Erian P, Benzer A. Preoperative stress and anxiety in day-care patients and inpatients undergoing fast-track surgery. Br J Anaesth. 2009 Aug;103(2):199-205. doi: 10.1093/bja/aep136. Epub 2009 May 30. Erratum in: Br J Anaesth. 2010 Dec;105(6):878. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Subjects' Anxiety Level before Education Subjects' anxiety level before education was measure using APAIS instrument. 2 months No
Primary Subjects' Anxiety Level after Education Subjects' anxiety level after education was measure using APAIS instrument. 2 months No
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