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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
School of Nursing, Midwifery & Physiotherapy
University of Nottingham
B63a, Medical School
Nottingham
NG7 2UH
United Kingdom
| tony.arthur@nottingham.ac.uk |
Study information
| Study design | Two-arm multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 30/11/2009 |
| Completion date | 30/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- China
- England
- United Kingdom
Study participating centre
School of Nursing, Midwifery & Physiotherapy
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
University/education
University of Nottingham (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
The First Affiliated Hospital of Henan Science and Technology University (China)
No information available
Luoyang City Central Hospital (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
