The efficacy of a brief mindset intervention on side effect reporting and experience of the COVID-19 vaccination

• Register: ANZCTR
• Last refreshed on: 14 June 2021
• Main ID: ACTRN12621000722897
• Date of registration: 09/06/2021
• Prospective Registration: Yes
• Primary sponsor: University of Auckland
• Public title: The efficacy of a brief mindset intervention on side effect reporting and experience of the COVID-19 vaccination
• Scientific title: The efficacy of a brief mindset intervention on side effect reporting and experience of the COVID-19 vaccination
• Date of first enrolment: 05/07/2021
• Target sample size: 660
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000722897.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Prof Keith Petrie

• Name: Prof Keith Petrie

Key inclusion & exclusion criteria

Inclusion criteria: Eligible for the COVID-19 vaccine
Have an active email address
18+ years old
English speaking
Exclusion criteria: Non-English speaking (as cannot give informed consent)
No email (as cannot send follow-up questionnaires)
Under 18 years old

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Inflammatory and Immune System - Other inflammatory or immune system disorders

vaccination response ;COVID-19 ;
vaccination response
COVID-19

Infection - Other infectious diseases

Intervention(s)

This study aims to alter how people view potential COVID-19 vaccination side effects through the use of a brief mindset intervention that frames symptoms as positive signals that the body is responding to the COVID-19 vaccination. Recent research has shown that changing patient mindsets can positively impact both the meaning and experience of side effects. Participants will be randomized to view a specifically made brief 5 minute video on an electronic tablet about the meaning of COVID-19 side effects and how they are often positive signals that the vaccine is bolstering the immune system or receive the standard information. This will be administered in the 30- minute wait period post their first COVID-19 vaccination. Side effects will be assessed at the end of the waiting period following the first vaccine and three days later. We will also assess side effects following the second vaccination in both groups. We hypothesise that this mindset intervention will decrease side effect reporting and improve the experience of any side effects experienced, resulting in less distress for the individual.

Primary Outcome(s)

Side effect reporting - measured through the SEAS (Mackrill et al., 2020).[Immediately after the COVID-19 vaccine
3 days after the first dose
3 days after the second dose
]

Secondary Outcome(s)

COVID-19 mindset evaluation - Five study-designed questions assessing the individuals’ mindset, beliefs, and feelings surrounding the COVID-19 vaccination will be asked.[Immediately after the first vaccination ]

Perceived attitudes to vaccines - The brief Vaccination Attitudes Examination Scale (VAX) (Martin & Petrie, 2017) [Immediately after the first vaccine ]

Intent to vaccinate in future - Participants will be asked via a study specific questionnaire about their intention to recommend the vaccine to family and friends, their intentions to be vaccinated against COVID-19 and other illnesses in the future.

[Three day follow-up after first and second vaccination dose
]

Side effect experience - as measured through study specific questions placed after the SEAS. [immediately after the COVID-19 vaccination
3 days after the first dose
3 days after the second dose ]

Past vaccination behavior
- Participants will be asked how many flu (influenza) vaccinations they have received over the past five years via a study specific question on a questionnaire
[Immediately after the first vaccine
]

Perceived sensitivity to vaccines - as measured by the brief 4-item Perceived Sensitivity to Vaccination Scale (Horne et al., 2013) [Immediately after the first vaccine ]

Secondary ID(s)

None

Source(s) of Monetary Support

University of Auckland

Ethics review

Status: Not approved
Approval date:
Contact:

Health and Disability Ethics Commitee