Information Sheet & Consent Form

Please have a read of the information sheet before signing the consent form.  
PARTICIPANT INFORMATION STATEMENT
Project Title: Re-frame the pain: Using attention and language to manage needle pain and distress in children
Principal Investigator: Dr Tasha Stanton, PhD - tasha.stanton@unisa.edu.au 
 

Dear Parent/Guardian,

You and your child have been invited to participate in our research project aiming to manage needle pain and distress in children.  

What is the study about?

Many people don’t like needles. This fear often stems from a bad experience as a child, as getting a needle for some kids can be a painful, distressing experience.  Talking to children in helpful ways after a needle can be really helpful in having them think about it in a less negative way and this might also help them cope better with needles in the future. We also know that there are ways that we can distract or direct attention that can help reduce pain. This may help decrease fear of future needles by making the experience of a needle, itself, less painful.

Does my child have to participate?

No.  As with all research at the University, participation is completely voluntary.  If you do decide to participate, you and your child are free to withdraw at any stage, without prejudice. 

Who can participate?

Your child can participate if they are:
  • aged between 8-12 years
  • attending school in South Australia
  • consent to receive the yearly flu vaccination.
Children with a history of severe allergic reaction (e.g., anaphylaxis) after a vaccine, severe egg allergies (e.g., respiratory distress/required epinephrine), a diagnosed anxiety disorder or post-traumatic stress disorder, or moderate-severe illness (with/without fever) on the day will be excluded.

What will I have to do?

We will ask you and your child to come to the University of South Australia, City East Campus Physiotherapy Clinic, Level 8, Centenary building. Here, you will be asked to complete some questionnaires asking about your child's previous vaccination experience and pain and fear associated with needles.

Your child will be randomised into one of four groups. All children will receive best standard care, but when they they receive their intervention, they will be videotaped. All children will have their flu vaccinations provided by a clinical nurse experienced in paediatric vaccinations and trained in the study procedures to minimise these effects and provide the best standard of care.

Two weeks after the vaccination, we will complete a short interview with you and your child on the phone. This interview will ask questions about what your child remembers about getting the needle. We will audio-record this interview so that we can fully capture your and your child’s answers.

The total time commitment required for your child is approximately 60 minutes. This includes the time taken to complete the initial baseline questionnaires before the vaccination (approximately 10-15mins),

Are there any risks?

The risks are the same as for a standard flu vaccination e.g. arm stiffness, soreness, redness, or swelling where the shot was given, drowsiness, tiredness, low grade fever, aches and distress. If these side effects occur they are usually mild and go away within a few days, usually without any treatment.

The risk of a flu shot causing serious harm or death is extremely small. However, a vaccine, like any medicine, may rarely cause serious problems, such as severe allergic reactions.
Are there any benefits?

The research we have proposed will have direct benefit for all children in South Australia.  Children that participate in our study will receive best standard care or enhanced care when receiving their flu vaccination. Additionally, our research may have future benefit for the children that participate in our study by decreasing the fear of needles in future procedures and potentially preventing disabling phobias of needle procedures that can occur.



This project has been approved by the University of South Australia's Human Research Ethics Committee. If you have any ethical concerns about the project or questions about your rights as a participant please contact the Executive Officer of this Committee, Tel: +61 8 8302 3118; Email: vicki.allen@unisa.edu.au.

If you wish to lodge a complaint about either the study or the way it is being conducted please contact the Executive Officer of UniSA HREC in the first instance, email: humanethics@unisa.edu.au or tel: 8302 3118.

T