Effect of Vibration and ShotBlocker on Pain and Fear Levels During Intramuscular Injection in Children in the Emergency Department

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorBurdur Mehmet Akif Ersoy University

About this trial

This prospective study is planned as a randomized controlled study. The aim of this study is to investigate the effects of vibration and the ShotBlocker method on pain and fear levels in children during intramuscular injection in the emergency department.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteering of the child and parent to participate in the study,

Children the ages between 5-10,

Having intramuscular (IM) injection.

Disqualifiers

Communication problem,

Children with any chronic illness,

Taking any medication that has an analgesic effect at least 6 hours before applying.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibration

    Device

    The vibration device was operated for 30 seconds with reference to previous studies. While the vibration continued, the nurse with a needle.Then, the vibration device continued to work in the waiting phase for 10 seconds. The vibration device was removed from routine intramuscular Injection procedure.

  • Shotblocker

    Device

    The protruding surface of the Shotblocker was placed on the procedure site. While applying pressure on the skin through the Shotblocker, the nurse performed with the needle through the opening in the center of the Shotblocker. During the 10-second waiting phase, the Shotblocker was kept at the procedure site with the same pressure. Then Shotblocker was removed from the skin and routine capillary intramuscular injection procedure was performed.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Vibration GroupExperimental treatment 1 intervention
Group B: Shotblocker GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Wong-Baker FACES Pain Rating Scale

In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.

Time frame
Through painful procedure completion, an average of 10 minutes

Secondary outcomes

1

Children's Fear Scale

CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).

Time frame
Through painful procedure completion, an average of 10 minutes.

Other outcomes

Sponsors and contacts

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