ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Oral and Gastrointestinal

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]

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]

Side-Effect Reporting

Side effects will be assessed by self-report on a (study-designed) questionnaire. The participant will complete this questionnaire.

Timepoint [1]

Immediately after Colonoscopy

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland

Address [1]

Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand

Country [1]

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]

Individual

Name [1]

Dominic Burton

Address [1]

Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

University of Auckland Human Participants Ethics Committee

Ethics committee address [1]

Research Office
Level 10, Building 620
49 Symonds Street,
Auckland 1010
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/10/2016

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Auckland District Health Board Research Review Committee

Ethics committee address [2]

Level 14
Support Building
Auckland City Hospital
2 Park Rd, 
Grafton, 
Auckland 1023

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

10/10/2016

Approval date [2]

Ethics approval number [2]

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

Prof Keith Petrie

Address

Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand

Country

New Zealand

Phone

+64 9 373 7599 ext.86564

Fax

kj.petrie@auckland.ac.nz

Contact person for public queries

Name

Keith Petrie

Address

Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand

Country

New Zealand

Phone

+64 9 373 7599 ext.86564

Fax

kj.petrie@auckland.ac.nz

Contact person for scientific queries

Name

Keith Petrie

Address

Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand

Country

New Zealand

Phone

+64 9 373 7599 ext.86564

Fax

kj.petrie@auckland.ac.nz

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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