Investigating the effectiveness of a pre-operative education intervention on reducing anxiety and improving recovery among Chinese cardiac patients

ISRCTN	ISRCTN87451169
DOI	https://doi.org/10.1186/ISRCTN87451169
Protocol serial number	N/A
Sponsor	University of Nottingham (UK)
Funders	University of Nottingham (UK), The First Affiliated Hospital of Henan Science and Technology University (China), Luoyang City Central Hospital (China)

Submission date: 02/11/2009
Registration date: 30/11/2009
Last edited: 30/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Antony Arthur
Scientific

School of Nursing, Midwifery & Physiotherapy
University of Nottingham
B63a, Medical School
Nottingham
NG7 2UH
United Kingdom

Email	tony.arthur@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Two-arm multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Anxiety measured by the Hospital Anxiety & Depression Scale at baseline and 7 days after surgery
Key secondary outcome measure(s)	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
Completion date	30/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	125
Key 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
Key exclusion criteria	1. Unable to give informed consent 2. Emergency cases 3. Previous cardiac surgery
Date of first enrolment	30/11/2009
Date of final enrolment	30/05/2010

Locations

Countries of recruitment

United Kingdom
England
China

Study participating centre

School of Nursing, Midwifery & Physiotherapy

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes