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ISRCTN
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ISRCTN87451169
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ClinicalTrials.gov identifier
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Public title
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Investigating the effectiveness of a pre-operative education intervention on reducing anxiety and improving recovery among Chinese cardiac patients
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Scientific title
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Investigating the effectiveness of a pre-operative education intervention on reducing anxiety and improving recovery among Chinese cardiac patients: a two-arm randomised controlled trial taking place in two centres
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Compared with usual care, participants who receive the pre-operative education intervention will show reduced anxiety and depression, reduce reported pain, reduce hospital admission, and reduce length of time in intensive care unit.
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Ethics approval
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1. The First Affiliated Hospital of Henan Science and Technology University - University Teaching and Research Committee approved on the 15th January 2009
2. Luoyang City Central Hospital approved on the 8th January 2009
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Study design
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Two-arm multicentre randomised controlled trial
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Countries of recruitment
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China
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Disease/condition/study domain
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Anxiety in elective cardiac surgery
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Participants - inclusion criteria
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1. Aged 18 years and over, either sex
2. Admission for any form of elective cardiac surgery at either of the two hospitals
3. Able to speak, read and write Chinese
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Participants - exclusion criteria
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1. Unable to give informed consent
2. Emergency cases
3. Previous cardiac surgery
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Anticipated start date
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30/11/2009
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Anticipated end date
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30/05/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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125
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Interventions
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Intervention: a structured leaflet based education intervention that includes:
1. A leaflet designed for Chinese cardiac patients and their families
2. 15 minute face-to-face oral explanation and opportunity to ask questions
3. Family in attendence if requested
Control: routine care
This form of intervention will take no more than 20 minutes and the total duration of follow-up for the two arms is 7 days following surgery.
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Primary outcome measure(s)
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Anxiety measured by the Hospital Anxiety & Depression Scale at baseline and 7 days after surgery
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Secondary outcome measure(s)
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1. Depression measured by the Hospital Anxiety & Depression Scale at baseline and 7 days after surgery
2. Pain measured by the Brief Pain Inventory at baseline and 7 days after surgery
3. Time to discharge from intensive care unit following surgery
4. Time to discharge from hospital following surgery
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Sources of funding
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1. University of Nottingham (UK)
2. The First Affiliated Hospital of Henan Science and Technology University (China)
3. Luoyang City Central Hospital (China)
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Trial website
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Publications
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Contact name
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Dr
Antony
Arthur
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Address
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School of Nursing, Midwifery & Physiotherapy
University of Nottingham
B63a, Medical School
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Email
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tony.arthur@nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Research Innovation Services
Kings Meadow Campus
Lenton Lane
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City/town
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Nottingham
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Zip/Postcode
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NG7 2NR
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Country
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United Kingdom
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Sponsor website:
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http://www.nottingham.ac.uk/
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Date applied
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02/11/2009
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Last edited
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30/11/2009
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Date ISRCTN assigned
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30/11/2009
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