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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorLingnan University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Visual-auditory or neurological deficits

Allergies to first-aid bandages

Having existing pain at the injection site

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Possession GroupExperimental treatment 1 intervention
Group B: No Possession GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Before injection (5 minutes before injection), during injection (real time) and after injection (1 minute after injection)
2

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.

Time frame
Before injection (5 minutes before injection), during injection (real time) and after injection (1 minute after injection)
3

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.

Time frame
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.
4

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.

Time frame
Before injection (5 minutes prior to injection) and after injection (1 minute after injection)

Secondary outcomes

1

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..

Time frame
1 minute after the manipulation of ownership status
2

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.

Time frame
Baseline, after participants signed the consent form (order is randomized by the computer)
3

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.

Time frame
Baseline, after participants signed the consent form (order is randomized by the computer)
4

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.

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

Other outcomes

Locations

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