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

NCT06313788 | Not Yet Recruiting

• 1 other identifier: EC007-2324
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric Pain

Keywords

mere possession, placebo, analgesia, pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Mood (rating the positive and negative emotions of the participants)

  1 minute after the manipulation of ownership status

• State-anxiety (Rating the participants' current anxiety level)

  Baseline, after participants signed the consent form (order is randomized by the computer)

• Fear of pain Rating

  Baseline, after participants signed the consent form (order is randomized by the computer)

• Magical thinking Rating

  Baseline, after participants signed the consent form (order is randomized by the computer)

• Pain Self-Efficacy

  1 minute after participants completed the mood scale

Study Arms (2)

Possession Group

EXPERIMENTAL

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

No Possession Group

NO INTERVENTION

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.

Interventions

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

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.

Possession Group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Visual-auditory or neurological deficits
• Allergies to first-aid bandages
• Having existing pain at the injection site

Sponsors & Collaborators

• Lingnan University: lead

Related Publications (17)

• 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

  BACKGROUND

• 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.

  PMID: 32227161 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33127585 BACKGROUND

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• 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

  BACKGROUND

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  BACKGROUND

• 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

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  PMID: 23084002 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Injections

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• WAI LAN VICTORIA YEUNG, PhD

  Lingnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Poon, Bachelor

CONTACT

(852) 6816 6795; kipoon@ln.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: One group of the participants will be told that they are involved in a marketing survey and will be given a band-aid as a token of appreciation for their participation. This constitutes the mere possession group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 15, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 3 months after publication
• Access Criteria: Everyone with access to OSF