Condition category
Mental and Behavioural Disorders
Date applied
02/11/2009
Date assigned
30/11/2009
Last edited
30/11/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.nottingham.ac.uk/

Funders

Funder type

University/education

Funder name

University of Nottingham (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes