Plain English Summary
Background and study aims:
Being in hospital can increase stress levels for patients and we want to reduce the anxiety of patients who are undergoing surgery. Other studies, have looked into improving patients experience using information about the surgical treatment. This includes booklets and videos which have shown to reduce anxiety. Our aim was to investigate the effect of 2-D animation to provide information to patients undergoing bowel surgery, given to patients before surgery, on anxiety levels (before and after surgery. We also investigated if this improved patient knowledge retention.
Who can participate?
Patients, aged 18 and above who were due to undergo bowel surgery.
What does the study involve?
There were two groups of patients that were undergoing bowel surgery, one group watched a 13 minute cartoon video showing the steps of treatment in hospital from the time of admission to discharge and the other group did not. All were given the usual level of information and treatment. Anxiety score was obtained at different stages (at pre-assessment clinic, on the day of surgery, after surgery and before discharge) for both groups of patients. In addition a simple short questionnaire to assess patients knowledge about treatment (covered in information leaflet and in cartoon video) was given to both groups and an evaluation questionnaire to the patients who watched the video.
What are the possible benefits and risks of participating?
The possible benefit of the study is the development of a prototype to build upon in which patients and hospital staff can access a resource that will both inform them of the treatment of bowel surgery and help to reduce the level of anxiety. There are no known risks of associated with taking part in this trial.
Where is the study run from?
Queen Elizabeth Hospital, Adelaide, South Australia
When is the study starting and how long is it expected to run for?
The study started recruiting in August 2011 and finished recruiting patients in January 2012.
Who is funding the study?
Queen Elizabeth Hospital, Adelaide, Australia
Who is the main contact?
Mr Samson Tou
samsontou@aol.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Samson Tou
ORCID ID
Contact details
Locum Consultant Colorectal Surgeon
Department of Colorectal Surgery
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131
samsontou@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of pre-operative 2-D animation information on peri-operative anxiety and knowledge retention in patients undergoing bowel surgery: A randomised pilot study
Acronym
Study hypothesis
Pre-operative 2-D information can reduce anxiety experienced by patients undergoing bowel surgery and improve the ability for patients to retain information during the preparation for surgery.
Ethics approval
Human Research Ethics Committee, SA Health, Australia, 5 August 2011, ref: 201111
Study design
Pilot randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Multi-media information for surgical intervention
Intervention
The intervention group watched a 2-D animation video depicting the in hospital journey whereas the control group received standard information that contained in the video but in a written format.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Anxiety score
Secondary outcome measures
1. Knowledge retention scores
2. Feedback questionnaire response
3. Clinical outcomes (30 days mortality/morbidity, length of hospital stay)
Overall trial start date
09/08/2011
Overall trial end date
10/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients undergoing elective bowel surgery either through open or laparoscopic approach
2. Age 18 and above
3. With ASA grade 1-3
4. Able to understand English with no major visual and/or hearing impairments
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Patients cannot understand English
2. Visual or hearing impairment
3. Unable to give informed consent
Recruitment start date
09/08/2011
Recruitment end date
10/01/2012
Locations
Countries of recruitment
Australia
Trial participating centre
Locum Consultant Colorectal Surgeon
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Queen Elizabeth Hospital (Australia)
Sponsor details
c/o Professor Peter Hewett
28 Woodville Road
Woodville South
Adelaide
SA 5011
Australia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Queen Elizabeth Hospital, Adelaide (Australia)
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