Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001601426p
Ethics application status
Submitted, not yet approved
Date submitted
18/11/2016
Date registered
21/11/2016
Date last updated
21/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of different preparation information on side effects following colonoscopy
Scientific title
Can changing standard preparation information to include an explanation of the nocebo effect reduce side effect reporting after colonoscopy?
Secondary ID [1] 290573 0
None
Universal Trial Number (UTN)
U1111-1189-9920
Trial acronym
Linked study record
ACTRN12616001415493p

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy
- procedure to examine the colon and rectum for early signs of cancer, or to diagnose causes of unexplained changes in bowel habits 301029 0
Condition category
Condition code
Mental Health 300821 300821 0 0
Studies of normal psychology, cognitive function and behaviour
Oral and Gastrointestinal 300822 300822 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Comparison of effect of standard information vs. standard information plus nocebo explanation on side effect reporting after colonoscopy.

Participants (routine outpatients receiving first colonoscopy at Auckland City Hospital) who are randomised into the intervention group will receive a standard consultation for colonoscopy (including side effect information) plus an explanation of nocebo effect. The nocebo explanation will outline the relationship between bodily sensations and individuals‘ attributions, expectations, and beliefs, and will offer an explanation of the nocebo phenomenon.

The intervention consultation will be delivered by a Registrar Gastroenterologist according to a standardised script.
The mode of delivery will be face to face and executed individually to each patient.
The intervention will be delivered once per patient over approximately a 10 minute period
The intervention will be delivered at the Endoscopy Unit located on Level 6 of Auckland City Hospital (Auckland, New Zealand).

After the intervention has been delivered participants will be asked to complete a post-colonoscopy symptom questionnaire. Participants will also be contacted via telephone 3 days after their colonoscopy to complete the same symptom questionnaire.
Intervention code [1] 296440 0
Behaviour
Comparator / control treatment
Participants (routine outpatients receiving first colonoscopy at Auckland City Hospital) who are randomised into the control group will receive a standard consultation for colonoscopy (including side effect information).

The control consultation will be delivered by a Registrar Gastroenterologist according to a standardised script.
The mode of delivery will be face to face and executed individually to each patient.
The control condition will be delivered once per patient over approximately a 10 minute period
The control condition will be delivered at the Endoscopy Unit on Level 6 of Auckland City Hospital (Auckland, New Zealand).

After the control consultation has been delivered participants will be asked to complete a post-colonoscopy symptom questionnaire. Participants will also be contacted via telephone 3 days after their colonoscopy to complete the same symptom questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 300244 0
Side-Effect Reporting

Side effects will be assessed by self-report on a (study-designed) questionnaire. The participant will complete this questionnaire.
Timepoint [1] 300244 0
Immediately after Colonoscopy
Secondary outcome [1] 329486 0
Side-Effect Reporting

Side effects will be assessed by self-report on a (study-designed) questionnaire. This questionnaire will be administered over telephone by the research assistant.
Timepoint [1] 329486 0
3 days after Colonoscopy

Eligibility
Key inclusion criteria
To be eligible to participate in the trial, individuals must:
-be over 18 years of age
-be a patient referred to the Auckland City Hospital Gastroenterology Department for a colonoscopy
-be naive to colonoscopy procedure (i.e. not have received a colonoscopy before)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will not be eligible to participate in this study if they:
-have had a previous colonoscopy
-are unable to give informed consent
-are unable to speak, write and read English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment (by sealed opaque envelope) will be executed in this trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2016
Actual
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
4/12/2017
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment outside Australia
Country [1] 8403 0
New Zealand
State/province [1] 8403 0
Auckland

Funding & Sponsors
Funding source category [1] 295008 0
University
Name [1] 295008 0
University of Auckland
Country [1] 295008 0
New Zealand
Primary sponsor type
Individual
Name
Keith Petrie
Address
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country
New Zealand
Secondary sponsor category [1] 293826 0
Individual
Name [1] 293826 0
Dominic Burton
Address [1] 293826 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 293826 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296361 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 296361 0
Research Office
Level 10, Building 620
49 Symonds Street,
Auckland 1010
New Zealand
Ethics committee country [1] 296361 0
New Zealand
Date submitted for ethics approval [1] 296361 0
10/10/2016
Approval date [1] 296361 0
Ethics approval number [1] 296361 0
Ethics committee name [2] 296362 0
Auckland District Health Board Research Review Committee
Ethics committee address [2] 296362 0
Level 14
Support Building
Auckland City Hospital
2 Park Rd,
Grafton,
Auckland 1023
Ethics committee country [2] 296362 0
New Zealand
Date submitted for ethics approval [2] 296362 0
10/10/2016
Approval date [2] 296362 0
Ethics approval number [2] 296362 0

Summary
Brief summary
Colonoscopy is a procedure used to examine the colon and rectum for early signs of cancer, or to diagnose causes of unexplained changes in bowel habits. The 30-60 minute-long examination is performed by a gastroenterologist, who may take biopsies of abnormal tissue (polyps) for testing. Colonoscopies are regularly offered to patients at Auckland City Hospital. Although complications are rare (perforation occurs approximately in 1 in 1000 examinations), unwanted side effects (such as abdominal pain and bowel distension) are commonly reported by patients (Senore et al., 2011).

In a healthcare context, the nocebo effect can be defined as the experience of symptoms, that are induced by the patient’s own negative expectations and/or by negative suggestions from clinical staff (Hauser, Hansen, & Enck, 2012). In a recent study we found that an explanation of the nocebo effect as a symptomatic experience influenced by negative expectations was effective in significantly reducing symptom reporting (Crichton & Petrie, 2015).

In this study we are investigating whether the nocebo effect has relevance to clinical medicine by examining whether changing standard verbal preparation information to include an explanation of the nocebo effect can reduce side effect reporting after colonoscopy. Reductions in side effect reporting may have considerable clinical benefits in terms of reducing non-compliance with medications, and reduction of illness burden and distress.

Design: Potential participants will be sent study information with their appointment letter. On the day of their appointment they will be provided with verbal + written information on the project, and invited to participate by the research assistant.

Once written informed consent has been obtained, a baseline questionnaire (including symptom data) will be completed. Participants will be randomised into one of 2 groups; either
a) control: standardized preparation for colonoscopy including side effect information, or
b) intervention: standardized preparation for colonoscopy including side effect information plus explanation of nocebo effect.

The control and intervention conditions will be delivered by a registrar gastroenterologist (according to a standardised script for each condition). The nocebo intervention will outline the relationship between bodily sensations and individuals‘ attributions, expectations, and beliefs, and will offer an explanation of the nocebo phenomenon.

The research assistant (who will be blind to condition) will collect participant symptom data following colonoscopy and at day 3 post-colonoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70590 0
Prof Keith Petrie
Address 70590 0
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country 70590 0
New Zealand
Phone 70590 0
+64 9 373 7599 ext.86564
Fax 70590 0
Email 70590 0
[email protected]
Contact person for public queries
Name 70591 0
Keith Petrie
Address 70591 0
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country 70591 0
New Zealand
Phone 70591 0
+64 9 373 7599 ext.86564
Fax 70591 0
Email 70591 0
[email protected]
Contact person for scientific queries
Name 70592 0
Keith Petrie
Address 70592 0
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country 70592 0
New Zealand
Phone 70592 0
+64 9 373 7599 ext.86564
Fax 70592 0
Email 70592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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