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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Pain
• Intervention / Treatment: Other: Possession of a customized placebo analgesic band-aid prior to vaccination or injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ki Poon, Bachelor; Phone Number: (852) 6816 6795; Email: kipoon@ln.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Possession Group; 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.	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 be encouraged to anticipate and describe how the owned band-aid is important to them and can help them cope with the forthcoming pain from injection.
No Intervention: No Possession Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity Rating (rating how much pain participants feel)	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.	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)	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.	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)	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.	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)	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.	Before injection (5 minutes prior to injection) and after injection (1 minute after injection)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lingnan University
• Investigators: Principal Investigator: WAI LAN VICTORIA YEUNG, PhD, Lingnan University

Publications and helpful links

General Publications

• Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.
• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
• 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
• 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.
• 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.
• 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
• Apell, J., Paradi, R., Kokinsky, E., & Nilsson, S. (2011). Measurement of children's anxiety during examination or treatment in hospital--a study evaluating the short-STAI/Matning av barns oro vid undersokning 45 eller behandling pa sjukhus--en studie som utvarderar short STAI. Nursing Science & Research in the Nordic Countries, 31(1), 45+. https://link.gale.com/apps/doc/A273786636/HRCA?u=anon~691011a5&sid=googleScholar&xid=05fcdcaa
• Vambheim SM, Lyby PS, Aslaksen PM, Flaten MA, Asli O, Martinussen LM. The Fear of Pain Questionnaire-III and the Fear of Pain Questionnaire-Short Form: a confirmatory factor analysis. J Pain Res. 2017 Aug 8;10:1871-1878. doi: 10.2147/JPR.S133032. eCollection 2017.
• Kingdon BL, Egan SJ, Rees CS. The Illusory Beliefs Inventory: a new measure of magical thinking and its relationship with obsessive compulsive disorder. Behav Cogn Psychother. 2012 Jan;40(1):39-53. doi: 10.1017/S1352465811000245. Epub 2011 May 16.
• Hanssen MM, Peters ML, Vlaeyen JWS, Meevissen YMC, Vancleef LMG. Optimism lowers pain: evidence of the causal status and underlying mechanisms. Pain. 2013 Jan;154(1):53-58. doi: 10.1016/j.pain.2012.08.006. Epub 2012 Oct 18.
• 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. Erratum In: Ann Behav Med. 2021 Aug 23;55(9):932. doi: 10.1093/abm/kaaa035.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: mere possession, placebo, analgesia, pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: EC007-2324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: share all IPD that underlie results in a publication on OSF
• IPD Sharing Time Frame: starting 3 months after publication
• IPD Sharing Access Criteria: Everyone with access to OSF
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No