NCT02755909

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

April 28, 2016

Last Update Submit

May 1, 2016

Conditions

Keywords

Cardiac surgery, anxiety, education

Outcome Measures

Primary Outcomes (2)

  • Subjects' Anxiety Level before Education

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

    2 months

  • Subjects' Anxiety Level after Education

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

    2 months

Study Arms (1)

Subjects

OTHER

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

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

Subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

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

    PMID: 2589657BACKGROUND
  • Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.

    PMID: 10589606BACKGROUND
  • 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.

    PMID: 15122417BACKGROUND
  • 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.

    PMID: 20478116BACKGROUND
  • 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.

    PMID: 8623940BACKGROUND
  • 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.

    PMID: 19483203BACKGROUND
  • 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.

    PMID: 23787971BACKGROUND
  • 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.

    PMID: 10702461BACKGROUND
  • 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.

    PMID: 7696068BACKGROUND
  • 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.

    PMID: 22588767BACKGROUND
  • 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.

    PMID: 23706369BACKGROUND
  • 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.

    PMID: 2068614BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Arif HM Marsaban, Consultant

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Anesthesiologist

Study Record Dates

First Submitted

April 28, 2016

First Posted

April 29, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 3, 2016

Record last verified: 2016-05