None listed
Conditions
Brief summary
This study aims to investigate whether simplifying and enhancing information medication sheets using placebo and nocebo research findings can increase the placebo response and decrease the nocebo response (reduce the attribution of symptoms as side effects). It also aims to assess whether enhancing the medication information sheet makes the information easier to understand and more impactful for patients. It is hypothesized that participants who receive the enhanced medication information sheet will demonstrate an increased placebo response (lower blood pressure, heart rate and anxiety). Secondly, it is hypothesized that participants who read the enhanced medication information sheet will have a lower nocebo response, that is, report fewer side effects. Thirdly, the enhanced medication information sheet will receive greater ratings of satisfaction, credibility and usage. Findings from this study will contribute to the existing literature on optimising medication information sheets as well as current placebo and nocebo research. In addition, medication information sheets are a widely accessible resource that is easily and affordably modified. Therefore, amending medication information sheets to increase the placebo and decrease the nocebo effect would be a feasible intervention to improve patients’ health outcomes by increasing responsiveness to the medication and decreasing side effects. This may encourage greater adherence to medication and reduce unnecessary costs stemming from non-adherence to medication, which would greatly benefit patients, the healthcare system and society.
Interventions
There will be one 1-hour face-to-face session for the participants with the student researcher. After baseline measures have been completed, participants will be randomised into the control or experimental group and asked to carefully read either a standard medication information sheet for Metoprolol or an enhanced medication information sheet. The enhanced medication information sheet has been adapted to increase the placebo response by boosting treatment expectations, reduce the nocebo respons
There will be one 1-hour face-to-face session for the participants with the student researcher. After baseline measures have been completed, participants will be randomised into the control or experimental group and asked to carefully read either a standard medication information sheet for Metoprolol or an enhanced medication information sheet. The enhanced medication information sheet has been adapted to increase the placebo response by boosting treatment expectations, reduce the nocebo response by using positive framing of risk information and explaining the nocebo effect to participants. The enhanced medication information sheet has also been adapted to be more user-friendly. It uses simpler language compared with the standard sheet, pictograms and a more reader-friendly layout of information. Both medication information sheets are double-sided and A4 in size. The medication sheet is only intended for the use of this study and is not a readily available source. Both researcher and participant will be blinded to which group the participant is in. The researcher will step out of the clinic room while the participant reads the medication information sheet to ensure the participant’s group allocation remains concealed. The participant will be asked to put the information sheet back in the envelope after they have read the information sheet and notify the researcher once completing this. All participants will be asked to take one 50mg dose of Metoprolol (actually a placebo pill consisting of microcrystalline cellulose) and fill out questionnaires while waiting for the drug to "take effect" (10 minutes). The student researcher will supervise participants taking the placebo tablet. All participants then complete the Trier Social Stress Test (TSST), which is a brief laboratory-based stress task. In both conditions, further measures will be collected immediately after participants complete the brief stress task. In both conditions, participants will be asked to complete follow-up questionnaires 24 hours after the intervention.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible to take part in this study if they are 18 years or older, fluent in English, able to complete the questionnaires and willing to participate in the study.
Exclusion criteria
Participants are not eligible to participate in the study if they are taking medications that interact with Metoprolol (e.g. anti-hypertensives, anti-arrhythmics) or have any medical conditions in which beta-blockers should not be used (e.g. asthma or diabetes).
Outcome results
None listed