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The effect of different preparation information on side effects following colonoscopy

Can changing standard preparation information to include an explanation of the nocebo effect reduce side effect reporting after colonoscopy?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001601426
Enrollment
86
Registered
2016-11-21
Start date
2016-12-01
Completion date
2017-12-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 ind

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.

Sponsors

Keith Petrie
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026