Assessing the severity of short-term side-effects to a well-known tablet

• Register: ISRCTN
• Last refreshed on: 10 December 2019
• Main ID: ISRCTN47470030
• Date of registration: 27/02/2015
• Prospective Registration: Yes
• Primary sponsor: King’s College London
• Public title: Assessing the severity of short-term side-effects to a well-known tablet
• Scientific title: Preventing the nocebo effect in healthy volunteers: the influence of side-effect framing in patient information leaflets on symptom development
• Date of first enrolment: 01/11/2015
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN47470030
• Study type: Interventional
• Study design: Randomised controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Rebecca Webster

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female
2. Over 18 years of age
3. Healthy
4. English speakers and writers

Exclusion criteria:
We will exclude participants:
1. With any chronic or acute illnesses which are currently causing symptoms
2. Who are pregnant, might be pregnant or are breastfeeding
3. Who list any allergies to any of the substances in the placebo tablet
4. Who have taken any painkillers within 4 hours before taking part in the study
5. Who have been drinking alcohol


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

The nocebo effect
Not Applicable

Intervention(s)

We will conduct a randomised controlled trial in which healthy volunteers will be randomised to receive an intervention or control patient information leaflet for a placebo tablet, before taking the tablet.

Control arm
The control information leaflet is akin to the information leaflets seen in current practice, as guided by EU guidelines, Council Directive (2010) and MHRA (2005) recommendations. It has been adapted for a placebo tablet, so all information provided is accurate for a placebo. As participants are not told what the tablet is or what it does, certain sections of the patient information leaflet are concealed, these include the sections: ‘What XXXXXXX is and what it is used for,’ ‘other medicines and XXXXXXX,’ ‘recommended doses,’ and ‘what XXXXXXX contains.’ The possible side effects section of the control patient information leaflet follows current guidelines for describing their probability, e.g. “common side effects (More than 1 in 10 people will be affected)”.

Intervention arm
The intervention information leaflet is exactly the same as the control, apart from what appears in section 4, ‘possible side effects.’ In the intervention patient information leaflet the probability of possible side effects is positively framed and presented in percentages e.g. “uncommon side effects (80% of people will not be affected).”

Primary Outcome(s)

Effect of patient information leaflets on side effect reporting as assessed by the symptom report questionnaire delivered one hour following ingestion of the placebo.
1. Incidence of side effects - number of participants between the two conditions who experience side effects
2. Number of side effects - the sum of confirmed symptoms which are tablet attributed
3. Severity of side effects - sum of all symptom scores that are tablet attributed

Secondary Outcome(s)

Effect of personality features and personal beliefs on the number of side effects reported and/or the severity of side effects reported. This will be measured by delivering questionnaires at baseline that measure modern health worries, pessimism, somatizitation, anxiety, beliefs about medicines, perceived sensitivity to medicines, and somatosensory amplification to see if scores on these measures predict scores on the symptom report questionnaire delivered 1 hour following ingestion of the placebo.

Secondary ID(s)

N/A

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

The Psychiatry, Nursing and Midwifery Research Ethics Subcommittee at King’s College London, 18/12/2014, ref: PNM/14/15-62

Results

• Results available: Yes
• Date Completed: 01/02/2017