Condition category
Surgery
Date applied
18/11/2012
Date assigned
28/11/2012
Last edited
28/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.tqeh.sa.gov.au

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes