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CompletedNCT02755909Updated May 3, 2016

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

An interventional study of Pre-anesthetic Education in Cardiac Surgery Patients, sponsored by Universitas Indonesia. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-03.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Universitas Indonesia · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Cardiac Surgery Patients

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Keywords

  • Cardiac surgery, anxiety, education
03

In context

Anxiety Disorders Unverified

5,113 studies on the registry are indexed under Anxiety Disorders; 1,418 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 4,380 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Universitas Indonesia is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralPre-anesthetic Education

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

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What researchers measure

Primary outcomes

  1. Subjects' Anxiety Level before Education

    Subjects' anxiety level before education was measure using APAIS instrument.

    Time frame: 2 months

  2. Subjects' Anxiety Level after Education

    Subjects' anxiety level after education was measure using APAIS instrument.

    Time frame: 2 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7. PubMed 2589657 ↗
  • Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003. PubMed 10589606 ↗
  • 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. doi: 10.1590/s0041-87812004000200001. Epub 2004 Apr 26. PubMed 15122417 ↗
  • Valenzuela Millan J, Barrera Serrano JR, Ornelas Aguirre JM. Anxiety in preoperative anesthetic procedures. Cir Cir. 2010 Mar-Apr;78(2):147-51. English, Spanish. PubMed 20478116 ↗
  • 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. doi: 10.1097/00000539-199603000-00002. PubMed 8623940 ↗
  • 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. PubMed 19483203 ↗
  • 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. PubMed 23787971 ↗
  • 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. doi: 10.1097/00000539-200003000-00036. PubMed 10702461 ↗
  • 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. doi: 10.1093/bja/74.2.180. PubMed 7696068 ↗
  • 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(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available. PubMed 22588767 ↗
  • 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. PubMed 23706369 ↗
  • Bensing J. Doctor-patient communication and the quality of care. Soc Sci Med. 1991;32(11):1301-10. doi: 10.1016/0277-9536(91)90047-g. PubMed 2068614 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02755909
Lead sponsor
Universitas Indonesia
Responsible party
Arif H. M. Marsaban (Consultant, Anesthesiologist, Universitas Indonesia) — Principal investigator
First posted
Apr 29, 2016
Start date
Dec 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
May 3, 2016

Study contacts

Arif HM Marsaban, Consultant
principal investigator · Universitas Indonesia
View the source record on ClinicalTrials.gov ↗

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