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

Lingnan University

Status: Not yet enrolling

Conditions: Pediatric Pain

Treatments: Other: Possession of a customized placebo analgesic band-aid prior to vaccination or injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06313788

EC007-2324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Possession Group

Experimental group

Description:

Participants will be presented with two leaflets about a branded band-aid, which specify its functions, e.g., "stop bleeding", "protect wounds" and "reduce pain". Participants read its analgesic component and mechanism (e.g., "reduces pain sensitization of peripheral nerves") to induce a positive expectation that the branded bandage can effectively help them alleviate pain. Next, participants rate their perceived effectiveness of the band-aid and their use intention. In order to mask the purpose of the study, they will also answer other distractor marketing questions, such as to guess the price of the band-aid and their impression on the package design of the band-aid. Participants in possession group 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.

Treatment:

Other: Possession of a customized placebo analgesic band-aid prior to vaccination or injection

No Possession Group

No Intervention group

Description:

Like participants in the possession condition, participants in the no-possession condition will also be first introduced to the function of a branded band-aid using the leaflet advertisement and asked to complete the marketing survey. They will be verbally thanked for their participation to take part in the marketing interview, but they will not be given any first-aid bandage as a souvenir.