The Effect of Pre-anesthetic Education on Cardiac Surgery Patients' Anxiety Level
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
The study aims to investigate the effect of pre-anesthetic education on patients undergoing cardiac surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 28, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedMay 3, 2016
May 1, 2016
3 months
April 28, 2016
May 1, 2016
Conditions
Keywords
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
OTHERPra-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.
Interventions
Education was done before the anesthetic procedure, using a flip chart made by the researchers.
Eligibility Criteria
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: 2589657BACKGROUNDMaranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
PMID: 10589606BACKGROUNDKiyohara 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: 15122417BACKGROUNDValenzuela 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: 20478116BACKGROUNDMoerman 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: 8623940BACKGROUNDWetsch 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: 19483203BACKGROUNDLaufenberg-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: 23787971BACKGROUNDKindler 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: 10702461BACKGROUNDMillar 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: 7696068BACKGROUNDJulian 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: 22588767BACKGROUNDBonnet 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: 23706369BACKGROUNDBensing 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arif HM Marsaban, Consultant
Indonesia University
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