Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain in Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorLingnan University

About this trial

In this proposed study, we aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection / vaccination) to help manage pediatric pain.

The proposed study builds on the well-known placebo effect, which occurs when individuals experience improvements in their conditions (e.g., pain relief) after using an inert substance (e.g., a placebo analgesic). This effect is primarily attributed to expectations about the placebo's effectiveness. We extend this line of research by demonstrating that, under certain circumstances, merely possessing a placebo can also lead to pain relief. This possession-based placebo analgesic effect arises from a sense of ownership, which enhances expectation that the owned placebo can provide benefits to the self. In this study, we will expand the scope of the possession-based placebo effect by examining its applicability in a real-life situation - we expect that by providing children an ownership of a first-aid bandage before their vaccination will improve their pain experiences.

Focusing on children's pain is critical for several reasons. First, pain is a common experience for children, who are often less mature and independent than adults in assessing and managing it. This makes them a vulnerable population that requires improved pain management interventions. Unfortunately, pain recognition and treatment in children are still inadequate (Birnie et al., 2014). Second, most past placebo analgesic studies have focused on adults, leading to significant knowledge gaps regarding its implications for children (Weimer et al., 2013). This knowledge gap is attributed to historical ethical and legal ambiguities that hindered randomized controlled trials involving children, resulting in their exclusion from research (Yan \& Munir, 2004). Third, research targeting children is essential to understand their unique circumstances and deliver appropriate benefits (Dresser, 1996). The U.S.

Department of Health and Human Services and the Food and Drug Administration (2001) have emphasized the need to broaden research participation among children. A recent motion by the Hong Kong Legislative Council on "Promoting the Development of Children's Healthcare Services" (2024) further highlights this commitment. Finally, age-related factors may influence individual's pain outcomes or responses. Children are more susceptible to the placebo effect than adults (Park et al., 2022), this may be due to the stronger influence of parental (compared to professional) expectations on children's pain perceptions (Gniß et al., 2020). Thus, caution is needed when generalizing adult findings to children (Weimer et al., 2013). Investigating the pain in children is crucial for developing tailored interventions for the pediatric population. This project could let healthcare practitioners and physicians learn 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 6 to 14 years;

Scheduled to receive a routine vaccination through the school;

Able to understand study instructions and provide self-reports of pain;

Parent/guardian provides informed consent and the child provides assent.

Disqualifiers

Pre-existing pain or injury at the intended injection site;

Known allergy or sensitivity to adhesive bandages;

Significant visual, hearing, or cognitive impairments that would interfere with participation;

Severe needle phobia or distress requiring special clinical management;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Possession of a Customized Placebo Analgesia

    Other intervention

    Participants in this open-label placebo (OLP) arm receive a band-aid customized with their preferred cartoon character and name inside a transparent plastic bag. Prior to vaccination, children hold and view the packaged bandage while receiving standardized verbal instructions explaining that although the bandage is not medicine and does not directly stop pain, possessing it may help them feel better and cope with the injection. Participants retain possession of the bandage without applying it to the skin until after the vaccination procedure is completed.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Band-aid possession groupExperimental treatment 1 intervention
Group B: No Possession GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Retrospective Post-Vaccination Pain Intensity Score

Assessed using the Revised Faces Pain Scale (FPS-R). The FPS-R is a validated pediatric self-report measure consisting of 6 facial expressions corresponding to pain scores of 0, 2, 4, 6, 8, and 10 (0 = "no pain", 10 = "very much pain"). Higher scores indicate higher retrospective pain intensity experienced during the injection.

Time frame
Immediately post-injection (within 1 to 5 minutes following vaccination)
2

Retrospective Pain Unpleasantness Numeric Rating Scale (NRS) Score

Assessed using a 0 to 10 Numeric Rating Scale (NRS). The NRS ranges from 0 ("No unpleasantness") to 10 ("Extreme unpleasantness"). Participants rate the actual unpleasantness experienced during the injection. Higher scores indicate greater retrospective pain unpleasantness.

Time frame
Immediately post-injection (within 1 to 5 minutes following vaccination)

Secondary outcomes

1

Positive and Negative Affect

Assessed using a 6-item mood questionnaire asking participants to rate their current emotional state (e.g., shy, nervous, confident, focused, afraid, happy). Each item is rated on a 5-point Likert scale ranging from 1 "Not at all" to 5 "Extremely". Higher scores indicate a stronger presence of that affect.

Time frame
Pre-injection
2

State Anxiety and Fear

Assessed using a 5-item scale measuring current feelings of anxiety and fear (e.g., feeling calm, tense, relaxed, worried, afraid). Participants rate each feeling on a 4-point scale ranging from 1 "Not at all" to 4 "Very obvious". Higher total scores indicate higher levels of state anxiety.

Time frame
Pre-injection
3

Perceived Self-Efficacy for Pain Coping Score

Assessed using a 5-item self-efficacy scale. Participants rate their confidence in their ability to perform regular daily activities (e.g., finishing classes, playing with friends, doing homework) after receiving the injection. Items are rated on a 5-point scale ranging from 1 "No confidence" to 5 "Completely confident". Higher average scores indicate greater self-efficacy in coping with post-vaccination functioning.

Time frame
Pre-injection and Post-injection
4

Anticipated Pain Unpleasantness Numeric Rating Scale (NRS) Score

Assessed using a 0 to 10 Numeric Rating Scale (NRS), ranging from 0 "No unpleasantness" to 10 "Extreme unpleasantness". Participants rate the unpleasantness they anticipate during the upcoming injection. Higher scores indicate greater anticipated pain unpleasantness.

Time frame
Pre-injection

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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