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

Pediatric Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313788
• Other study ID #: EC007-2324
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Lingnan University
• Contact: Ki Poon, Bachelor
• Phone: (852) 6816 6795
• Email: kipoon[@]ln.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lingnan University

References & Publications (17)

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, 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

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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.
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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