Contact information
Type
Scientific
Primary contact
Dr Antony Arthur
ORCID ID
Contact details
School of Nursing
Midwifery & Physiotherapy
University of Nottingham
B63a
Medical School
Nottingham
NG7 2UH
United Kingdom
tony.arthur@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
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.
Ethics approval
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
Study design
Two-arm multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anxiety in elective cardiac surgery
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Anxiety measured by the Hospital Anxiety & Depression Scale at baseline and 7 days after surgery
Secondary outcome measures
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
Overall trial start date
30/11/2009
Overall trial end date
30/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
125
Participant exclusion criteria
1. Unable to give informed consent
2. Emergency cases
3. Previous cardiac surgery
Recruitment start date
30/11/2009
Recruitment end date
30/05/2010
Locations
Countries of recruitment
China
Trial participating centre
School of Nursing, Midwifery & Physiotherapy
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Nottingham (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Funder name
The First Affiliated Hospital of Henan Science and Technology University (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Luoyang City Central Hospital (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list