None listed
Conditions
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 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
Study design
Eligibility
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