Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain Experiences in Child Patients

Overview

Pain is common among children. Given that children are not as mature and independent in assessing or treating their pain as adults, they are a relatively vulnerable group in terms of pain management and are in need of additional attention. However, there is still insufficient recognition and treatment of pain in children. Taken the procedure of injection/vaccination in children as an example, child patients usually wait for their turn to take the injection from the nurse/doctor, during which anxiety and fear of pain develop. As children are less able to manage their pain than adults, the fear they develop during the waiting time, together with the pain they actually felt after the treatment, can bring negative experiences to them. In this proposed project, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection / vaccination) to help managing pediatric pain.

Detailed description

In a series of experiments, Yeung and colleagues found that participants who merely possessed an object framed as having a particular function or benefit experienced an elevation of their self-efficacy in a corresponding domain. For example, participants who possessed reading materials regarded themselves as more knowledgeable. This is because people are inclined to associate themselves with the objects they possess, whose attributes are thus incorporated as part of the self. This mere possession effect also extends to the area of placebo analgesia.

Previous placebo analgesic research typically showed pain reduction after using a placebo analgesic. However, a newly emerged line of research demonstrated that sometimes, people who were merely given possession of a placebo analgesic, without using it, already reported better pain outcomes. This is presumably attributable to the mere possession of the object that enables them to believe they have already received the intended benefit of using it. In Yeung, Geers, and Colloca's study, they found that merely possessing a placebo analgesic yielded placebo analgesia similar to a situation where a placebo analgesic was actually used. The researchers claimed that this observed possession effect was due to the positive expectancy derived from owning a placebo analgesic, i.e., participants expected that the owned placebo analgesic could bring benefits to them.

The finding of the above-mentioned possession-based placebo analgesic effect is encouraging as it can inform healthcare practitioners and physicians about the possibility of tailoring, forming, or optimizing their medical intervention strategies to enhance positive pain outcomes and novel pain management. For instance, practitioners, clinicians, and dentists could consider tailoring their therapeutic interaction and treatment by incorporating an appropriate possession procedure to reduce undesired negative pain outcomes. In this proposed project, the investigators attempt to apply a possession procedure to child patients prior to their treatment that would induce pain.

The investigators hypothesize that acquiring the ownership of a first-aid bandage would contribute to pain alleviation by enhancing children's self-efficacy to cope with pain. The investigators expect that children who receive a first-aid bandage prior to injection would report a lower level of estimated pain (before injection) and lower real-time pain intensity and severity (during injection) than children who do not receive the first-aid bandage prior to the injection.

Interventions

• Other Possession of a customized placebo analgesic band-aid prior to vaccination or injection
  Participants will be told that in order to thank them for doing the marketing interview, as a token of appreciation, they will receive a free band-aid with a customized cartoon of their preference. They will be displayed band-aids with different cartoon images (such as Luffy, minions etc) from which they can freely choose their favorite one . They will be asked to sign their name on the band-aid. This is to establish their sense of ownership. Lastly, with the assistance of the parent, they will

Primary outcome measures

• Pain intensity Rating (rating how much pain participants feel) [Time frame: Before injection (5 minutes before injection), during injection (real time) and after injection (1 minute after injection)]
• Pain intensity Measurement (measure how much pain participants feel) [Time frame: Before injection (5 minutes before injection), during injection (real time) and after injection (1 minute after injection)]
• Pain Threshold (record the first-time participants feel the pain) [Time frame: During real time injection, participants will report the first pain sensation they feel (the investigators will record it in milliseconds). It will vary across participants.]
• Pain unpleasantness (rating how unpleasant participants feel about the pain) [Time frame: Before injection (5 minutes prior to injection) and after injection (1 minute after injection)]

Secondary outcome measures (7)

• Mood (rating the positive and negative emotions of the participants) [Time frame: 1 minute after the manipulation of ownership status]
• State-anxiety (Rating the participants' current anxiety level) [Time frame: Baseline, after participants signed the consent form (order is randomized by the computer)]
• Fear of pain Rating [Time frame: Baseline, after participants signed the consent form (order is randomized by the computer)]
• Magical thinking Rating [Time frame: Baseline, after participants signed the consent form (order is randomized by the computer)]
• Pain Self-Efficacy [Time frame: 1 minute after participants completed the mood scale]
• Self-efficacy to tackle pain [Time frame: 1 minute after participants completed the Pain Self-Efficacy Questionnaire (PSEQ)]
• Expectation of Pain Severity [Time frame: 5 minutes prior to injection]

Eligibility criteria

Inclusion criteria

• Male or female paediatric patients (aged 6-11 years old) in good general health condition and requiring intramuscular injections
• Submission of signed and dated informed consent form (from paediatric patients and their parents)
• Commitment to comply and cooperate with the implementation of the study procedures

Exclusion criteria

• Visual-auditory or neurological deficits
• Allergies to first-aid bandages
• Having existing pain at the injection site

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Yeung, V. W. L., Loughnan, S., Kashima, Y., Lun, V. M. C., Yeung, S. S. (2017). When My Object Becomes Me: The Mere Ownership of an Object Elevates Domain Specific Self Efficacy. Applied Psychology, 66(4), 710 741. doi:10.1111/apps.12099
• Wai-Lan Yeung V, Geers AL, Colloca L. Merely Possessing a Placebo Analgesic Improves Analgesia Similar to Using the Placebo Analgesic. Ann Behav Med. 2020 Sep 1;54(9):637-652. doi: 10.1093/abm/kaaa007. PMID 32227161
• Yeung, V. W. L., Chan, C. P., Yau, E. K., Lok, W. K., Lun, V. M. C., Chan, E. (2020). I own therefore I can: Efficacy based mere ownership effect. Journal of Experimental Social Psychology, 90, 104005. doi:10.1016/j.jesp.2020.104005
• Yeung VW, Geers AL. Prior Pain Exposure and Mere Possession of a Placebo Analgesic Predict Placebo Analgesia: Findings From a Randomized, Double-Blinded, Controlled Trial. J Pain. 2021 Apr;22(4):415-431. doi: 10.1016/j.jpain.2020.10.004. Epub 2020 Oct 27. PMID 33127585
• Yeung VW. Temporal expectancy induced by the mere possession of a placebo analgesic affects placebo analgesia: preliminary findings from a randomized controlled trial. Sci Rep. 2022 Jan 26;12(1):1395. doi: 10.1038/s41598-022-05537-9. PMID 35082351
• Beggan, J. K. (1992). On the social nature of nonsocial perception: The mere ownership effect. Journal of Personality and Social Psychology, 62(2), 229-237. https://doi.org/10.1037/0022-3514.62.2.229
• Nesselroade, K. P., Jr., Beggan, J. K., & Allison, S. T. (1999). Possession enhancement in an interpersonal context: An extension of the mere ownership effect. Psychology & Marketing, 16(1), 21-34. https://doi.org/10.1002/(SICI)1520-6793(199901)16:1<21::AID-MAR2>3.0.CO;2-9
• Laurent, J., Catanzaro, S. J., Joiner, T. E., Jr., Rudolph, K. D., Potter, K. I., Lambert, S., Osborne, L., & Gathright, T. (1999). A measure of positive and negative affect for children: Scale development and preliminary validation. Psychological Assessment, 11(3), 326-338. https://doi.org/10.1037/1040-3590.11.3.326

Identifiers

NCT: NCT06313788 · EC007-2324

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗