Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain Experiences in Child Patients
- Conditions
- Pediatric Pain
- Interventions
- Other: Possession of a customized placebo analgesic band-aid prior to vaccination or injection
- Registration Number
- NCT06313788
- Lead Sponsor
- Lingnan University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Visual-auditory or neurological deficits
- Allergies to first-aid bandages
- Having existing pain at the injection site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Possession Group Possession of a customized placebo analgesic band-aid prior to vaccination or injection 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.
- Primary Outcome Measures
Name Time Method Pain intensity Measurement (measure how much pain participants feel) Before injection (5 minutes before injection), during injection (real time) and after injection (1 minute after injection) Pain intensity will be measured by the Faces Pain Scale - Revised (FPS-R):
The scale shows 6 simple cartoon faces, with the face on the far left being expressionless (No pain) and the intensity of pain gradually increasing to the face on the far right showing a very painful expression (Very much pain).
FPS-R will be used 5 mins before injection, during real-time injection, and 1 min after injection.
The higher the Visual Analog score, the greater the pain intensity.Pain intensity Rating (rating how much pain participants feel) Before injection (5 minutes before injection), during injection (real time) and after injection (1 minute after injection) The intensity of pain will be measured by Pain Intensity Numerical Rating Scale (NRS):
* 5 mins before injection, participants anticipate "how much pain do you expect to have during injection?", using NRS from 0= "No pain at all" to 10= "Extreme pain".
* During real-time injection, participants report their pain intensity using the same NRS.
* 1 min after injection: participants report their pain intensity again using the same NRS.
The higher the NRS rating, the higher the pain intensity.Pain Threshold (record the first-time participants feel the pain) 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. The investigators record the time when the participants first report feeling their initial pain sensation.
Participants verbally report the point at which they begin to feel pain at the injection site.
The investigators record the time (in millisecond) participants take to physically perceive a pain sensation from the time of injection.
The longer/later the time reported means the greater the pain threshold.Pain unpleasantness (rating how unpleasant participants feel about the pain) Before injection (5 minutes prior to injection) and after injection (1 minute after injection) It measures how emotionally unpleasant participants feel about the pain.
This is measured by the Visual Analog Scale (VAS): participants draw a cross on a 10 cm line which has a label on the extreme left side stating, "no unpleasant at all", and a label on the extreme right side of the line stating, "the more unpleasant".
5 mins before injection, participants will estimate their unpleasantness level using the VAS.
1 min after the injection, participants report their unpleasantness level using the VAS.
The longer the distance between the far-left point of the line to the cross participants drew, the higher the unpleasantness level.
- Secondary Outcome Measures
Name Time Method Mood (rating the positive and negative emotions of the participants) 1 minute after the manipulation of ownership status Participants' positive and negative mood upon obtaining (vs. not obtaining) the ownership of a bandage will be measured by the Positive and Negative Affect Schedule for Children (PANAS-C) Scale
PANAS-C consists of 9 different descriptors, four of which relates to positive affects, such as "Excited" and the other five relates to negative affects, such as "Upset".
Participants choose a number that best reflects their current mood for each item (from 1= very slightly or not at all, to 5=extremely).
The higher the mean score of positive affect items, the more positive emotion the participants feel.
The higher the mean score of the negative affect items, the more negative emotion the participants feel..Self-efficacy to tackle pain 1 minute after participants completed the Pain Self-Efficacy Questionnaire (PSEQ) Participants' self-perceived efficacy concerning their ability to handle the pain will be measured by the Self-Efficacy of Pain Resilience Scale.
This rating scale measures participants' self-efficacy to handle the pain about injection. For example, "During the injection, I could manage any discomfort". Participants rate on a 7-point Likert scale based on their agreement (from 1= "Strongly disagree" to 7= "Strongly agree").
The higher the mean score, the greater their perceived self-efficacy in tackling pain.Expectation of Pain Severity 5 minutes prior to injection Participants will be asked to anticipate "What would be the severity of pain you expect to experience when you receive injection?" from 1 = "No pain at all", to 5 = "Excruciating".
The higher the score, the greater the expected pain severity.Fear of pain Rating Baseline, after participants signed the consent form (order is randomized by the computer) Participants' fear of pain will be measured by Fear of Pain Questionnaire (FOP).
FOP contains 30 items describing painful experiences in terms of severe pain, minor pain, medical pain (e.g., "breaking your arm"). Participants rate the extent to which they had a fear of experiencing the pain associated with each item from 1 = "Not at all" to 5 = "Extreme".
The higher the mean score, the greater the fear of pain.Pain Self-Efficacy 1 minute after participants completed the mood scale The investigators will use the Pain Self-Efficacy Questionnaire (PSEQ) to measure the confidence level of the participants in handling pain. It contains 8 items. Participants rate how sure they are of being able to do something when they are in pain (from 0= "Not at all confident" to 6=" Completely confident"). For example, "I can cope with my pain without medication."
The higher the mean score, the greater their perceived self-efficacy in tackling pain.State-anxiety (Rating the participants' current anxiety level) Baseline, after participants signed the consent form (order is randomized by the computer) Participants' state anxiety will be measured by the State-Trait Anxiety Inventory for Children State form (STAIC-S)
This scale contains 6 statements assessing participants' current state of anxiety. Three items measure the absence of anxiety (e.g., "I feel calm") and the other three items measures the presence of anxiety (e.g., "I feel tense"). Participants use a number from 1 = "Not at all" to 4 = "Very much" to indicate their anxiety level for each item. The absence of anxiety items will be reverse scored.
The higher the mean rating score, the higher the state anxiety level.Magical thinking Rating Baseline, after participants signed the consent form (order is randomized by the computer) Participants' belief that one's ideas, thoughts, actions, words, or use of symbols can influence the course of events in the material world will be measured by the Illusory Beliefs Inventory.
This scale measures participant's magical thinking including their Magical Beliefs, Spirituality, and Internal State and Thought Action Fusion. It contains 24 items (e.g., "I do something special to prevent bad luck"). Participants rate on a 7-point Likert scale based on their agreement (from 1 = "Strongly disagree" to 7 = "Strongly agree").
The higher the mean score, the greater the magical thinking tendency.