None listed
Conditions
Brief summary
Many people are terrified of and avoid needles. This fear often stems from bad experiences with receiving needles as a child. For many children getting a needle can be a painful, distressing experience. This fear can have devastating consequences, leading to vaccine hesitancy and outbreaks of preventable diseases. Our research aims to reduce the negative impact of needle procedures in children. We aim to test 2 different strategies – using attention and using positive language to reframe memory – for their ability to reduce needle pain and fear in children aged 8-12 years of age undergoing flu vaccination in South Australia. Importantly, we will also test if these strategies, when combined together, have even greater effects. Children’s memories of needle-related pain are a powerful predictor of future pain experiences. Memory of pain can be distorted (recalling higher levels of pain than initial pain reports) and this is associated with higher subsequent pain, distress and worse medical compliance. Children’s memories for pain can be changed through use of positive language to reframe memory of past painful experiences. These interventions involve talking to children for a few minutes to emphasise the positive aspects of a past painful experience, correct exaggerations in recall, and increase their self-efficacy in their pain coping. We want to test the effect of such an intervention for flu vaccination related pain intensity and pain-related fear. We can also reduce the pain and fear associated with needles by reducing how much the needle hurts. Attention and expectation can impact how much something hurts. Recent work has shown that even small shifts in attention can reduce pain. For example, when you expect to feel something in one of two locations on your skin (so you have to pay attention to both locations), a stimulus provided between those two locations hurts less than when your attention is not divided. Because you feel needle pain in one small area of skin, dividing attention may be useful to reduce the pain felt from a needle merely by taking advantage of the way our nervous system works. We will recruit a minimum of 40 children that have consented to undergo flu vaccination. They will be randomly assigned to 1 of 4 groups – using positive language, dividing attention, both, or neither (usual standard care). An experienced paediatric nurse will provide the flu vaccinations and we will measure how much pain (intensity) and fear (pain-related) that children expect at baseline, how much pain/fear they experienced during the vaccination, how much pain/fear they remember experiencing (measured 2 weeks after the vaccination), and how much pain/fear they expect for a future vaccination. We will also explore feasibility in terms of : recruitment rate, retention rate, feasibility/acceptability of the interventions (based upon parent, child, nurse experiences) and fidelity of the intervention provision.
Interventions
All children that participate in the study will receive a single 0.5 mL intramuscular injection to the upper arm of Fluarix Tetra Inactivated influenza Vaccine. This vaccine will include the following strains as recommended by the World Health Organisation (WHO) for inclusion in the 2018 Southern Hemisphere vaccine: A/Michigan/45/2015 (H1N1) pdm09-like virus; A/Singapore/INFIMH-16-0019/2016(H3N2)-like virus; B/Phuket/3037/2013-like virus; B/Brisbane/60/2008-like virus. The injection will be provided via a one-on-one intervention by a paediatric nurse experienced in administering flu vaccinations. When possible, a parent or guardian of the participating child will be present during the vaccination. The injections will primarily be provided at the University of South Australia, City East Campus, but may also be provided at schools in South Australia (if sufficient interest within a school). The two clinical nurses involved in this trial will each receive ~4 hours of training, including written information on the intervention procedures for each group, guided practice of each of the intervention, and assessment of intervention fidelity using pilot participants. Training and assessment of intervention fidelity prior to trial commencement will be completed by CIs Stanton and Noel. Participants will be randomised to one of 4 intervention groups: 1. Positive memory reframing; 2. Divided attention; 3. Positive memory reframing plus divided attention; 4. Usual standard care. All interventions will be videotaped during the trial to allow for assessment of intervention fidelity and to allow for specific coding of the strategies used in each intervention, most relevant to categorise the strategies used in ‘usual care’. Group 1. Positive memory reframing: For many children getting a needle can be a painful, distressing experience. This fear can have significant consequences, leading to vaccine hesitancy. Pain influences children long after the painful stimulus is removed.1 Children’s memories of needle-related pain are a powerful predictor of future pain experiences, and are more influential to future pain than the initial experience of pain itself.2-4 Memory is susceptible to distortion. Negative biases in pain memories (recalling higher levels of pain as compared to initial pain report) are associated with higher subsequent pain, distress, and worse medical compliance.2,5 Children’s pain memory development is influenced by multiple factors,1,6 including the child’s anxiety,7 pain-related fear,8 sex,9 and age.10 Children’s memories for pain are malleable through post-event information,11 yet very few studies have examined memory reframing interventions in the context of children’s recall of (needle) pain.12 Positive memory reframing involves talking to children for a few minutes to emphasise the positive aspects of a past painful experience, correct exaggerations in recall, and foster a sense of self-efficacy in their pain coping.13 Participants randomised to this group will receive an individualised intervention that aims to focus on positive aspects of their pain needle experience to promote a feeling of self-efficacy in their coping abilities. To individualise the intervention, the clinical nurse will first speak with the parent or guardian about the child’s previous needle experience with the aim of determining 1-2 positive things that occurred during the past experience. The nurse will then engage with the child and have the child recall positive features of their past needle experience, even if minimal (e.g., a friendly nurse), that will be supplemented by parent input (if available). Any exaggerations of recall will be addressed (e.g., the previous needle procedure actually only took 2 minutes not 10 minutes) and will be supported by parent input (if available). The nurse will also praise specific strategies that the child used well (e.g., deep breaths) and will affirm that the child is brave, together promoting increased self-efficacy for pain coping. Following this, the needle will be provided. A similar process will occur after the injection, with the clinical nurse praising how well the child handled the experience, pointing out specific strategies that they used that were excellent, affirming their bravery, and including a positive statement for the future (e.g., “You did so well, the next time you get a needle you will do excellent”). This intervention will take ~6 minutes to provide (time differences may occur depending on the time it takes for parents/children to provide information about the previous vaccine experience). Group 2. Divided attention. Another way to reduce the negative impact of pain and fear related to needle procedures is to decrease the intensity of the painful experience itself. It is well established that attention and expectation are important contributors to the experience of pain.14-16 For example, distraction (i.e., removal of attention) during a needle procedure has been shown to reduce pain.17 Recent work has shown that the effects of attention and expectation are more spatially precise than previously realised.18 In other words, even small shifts in attention can reduce pain. For example, when attention/expectation are divided between two locations on the arm (you expect to receive a painful stimulus in one of two locations), it has been shown that a stimulus provided between those two locations feels less painful than when attention/expectation are not divided.17 Because needles and their resultant pain are spatially precise (e.g., you feel it in one small area of skin), this paradigm may be useful to reduce the pain intensity felt from a needle merely by taking advantage of the way our nervous system works. Prior to receiving the vaccine injection, participants in this group will play a game that results in them dividing their attention between two areas on their upper arm. The nurse will identify two spots on the child’s upper shoulder, one above and one below the location where the vaccination will be given. Using either the rubber end of a pencil or their index finger, the nurse will touch the child’s skin in spot one or spot two (random order, slightly varying exact location each time) and will ask the child to identify which spot was touched. If this is too easy (i.e., child getting all correct), then the nurse will increase the speed of touching and if still too easy, will then provide the touch in triplets or quadruplets, with the child needing to identify the pattern of touch (e.g., spot 1, spot 2, then spot 2). Prior to the needle, participants will be told that because touching the skin in the two spots like this makes the two spots go a bit numb, the needle will be provided in one of the two spots and their very important job is to figure out which spot the needle was given to. Consistent with past study findings (and in order to take advantage of the pain-relieving properties of divided attention), the nurse will provide the needle in between the two spots. The child will be asked at the end to identify to which spot the needle was given. This intervention will take ~4 minutes to provide. Group 3. Positive memory reframing and divided attention. This group will receive both strategies to test whether there is a super-additive effect on pain and fear when high levels of self-efficacy for pain coping are promoted and when attention is divided to decrease the pain of the needle itself. This group will receive the positive memory reframing first, followed by the divided attention game. Identical procedures will be used such that following the needle, participants will receive positive memory reframing strategies (as delivered in group 1) and will be asked about where they thought the needle was given (as performed in group 2). This group will take 7-8 minutes to provide the intervention. References: 1. Noel M, Chambers CT, Petter M, McGrath PJ, Klein RM, Stewart SH. Pain Manag. 2012;2:487. 2. von Baeyer CL, Marche TA, Rocha EM, Salmon K. J Pain. 2004;5:241. 3. Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. Pain. 2012;153:1563. 4. Noel M, Pavlova M, McCallum L, Vinall J. Can Psychol. 2017;58:58. 5. Arntz A, van Eck M, Heijmans M. Behav Res Ther. 1990;28:29. 6. Noel M, Palermo TM, Chambers CT, Taddio A, Hermann C. Pain. 2015;156:31. 7. Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. J Pediatr Psychol. 2012;37:567. 8. Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Pediatrics. 2006;118:651. 9. Hechler T, Chalkiadis GA, Hasan C, Kosfelder J, Meyerhoff U, Vocks S, Zernikow B. J Pain. 2009;10:586. 10. Noel M, Rabbitts JA, Tai GG, Palermo TM. Pain. 2015;156:800. 11. Noel M. J Pediatr Psychol. 2016;41:232. 12. Bruck M, Ceci SJ, Francoeur E, Barr R. Child Development 1995;66:193-208. 13. Noel M, McMurtry CM, Pavlova M, Taddio A. Pain Pract. 2017. DOI: 10.1111/papr.12572. 14. Miron D, Duncan GH, Bushnell MC. Pain 1989;39:345-52. 15. Quevedo AS, Coghill RC. J Neurosci 2007;27:11635–11640. 16. Johnston NE, Atlas LY, Wager TD. PloS ONE 7:e38854. 17. Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD005179. 18. Stanton TR, Gilpin H, Reid E, Spence C, Mancini F, Moseley GL. J Pain 2016; 20:753-66.
Sponsors
Study design
Eligibility
Inclusion criteria
We will recruit 256 children, aged between 8-12 years who are living in South Australia and who have consented to receive a yearly flu vaccination. Both the child and their parent/guardian will provide written informed consent.
Exclusion criteria
Children with a history of severe allergic reaction (e.g., anaphylaxis) after a vaccine, severe egg allergies (e.g., respiratory distress/required epinephrine), with a diagnosed anxiety disorder/post traumatic stress disorder, or moderate-severe illness (with or without fever) on the day will be excluded.