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Cardiac Surgery PatientsNCT02755909

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

A study testing Pre-anesthetic Education in people with Cardiac Surgery Patients, run by Universitas Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cardiac Surgery Patients
What is being tested?
Pre-anesthetic Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
Dec 2015to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: The Effect of Pre-anesthetic Education on Patients' Anxiety Level Undergoing Cardiac Surgery

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).

Being tested
Pre-anesthetic Education
Keywords
Cardiac surgery, anxiety, education
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-anesthetic EducationBehavioural

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

Study groups in NCT02755909
Study groupRoleWhat they receive
SubjectsOtherPra-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.
Receives: Behavioral: Pre-anesthetic Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjects' Anxiety Level before Education

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

    Measured: 2 months

  2. Subjects' Anxiety Level after Education

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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02755909
Sponsor's protocol ID
IndonesiaUAnes002
Status last verified
May 2016
First submitted
28 Apr 2016
Last updated
3 May 2016
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Pre-anesthetic Education in people with Cardiac Surgery Patients, run by Universitas Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects' Anxiety Level before Education (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755909, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.

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