Effect of Vibration and ShotBlocker on Pain and Fear Levels During Intramuscular Injection in Children in the Emergency Department
The Effect of Vibration and ShotBlocker on Pain and Fear Levels During Intramuscular Injection in Children in the Emergency Department: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Emergency departments are among the clinical areas where invasive procedures frequently encountered by children are performed. Intramuscular injections are one of the most common procedures performed on children in the emergency department, and they can cause pain and fear, leading to negative experiences for children. In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and fear management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain.
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.
The study will be conducted in three groups (Vibration, ShotBlocker, and Control), and a total of 120 children will be enrolled, with 40 participants in each group. The primary outcome will be pain intensity. The sample size was determined using an a priori power analysis performed with G*Power version 3.1.9.7. The calculation was based on a one-way analysis of variance (ANOVA) with three groups, an alpha level of 0.05, 80% statistical power (1-β = 0.80), and a Cohen's effect size (f) of 0.30. The analysis indicated that a minimum of 111 participants would be required. Considering potential participant attrition and missing data, the sample size was increased to 120 participants, with 40 children allocated to each group (Vibration Group, n = 40; ShotBlocker Group, n = 40; and Control Group, n = 40).
Data were collected through face-to-face interviews using three forms: the "Data Collection Form," the "Wong-Baker FACES Pain Scale," and the "Children's Fear Scale." Data Collection: Before starting the study, parents of children meeting the sample selection criteria will be briefly informed about the purpose of the study, and written consent will be obtained for their participation. Then, data collection tools will be administered. Forms will be collected through face-to-face interviews. After a child is selected, the nurse working at the institution will administer the intramuscular injection to the child, while routine injections will be given to the control group children. No intervention will be performed. The nurse will apply vibration to the vibration group children. In the vibration group, vibration will begin 30 seconds before the injection, and no vibration will be applied during the 10-second waiting phase while the nurse performs the intramuscular injection. In the shotblocker group children, the nurse will position the device between the injection site and the heel prick blood sample.
Shotblocker: This is a plastic device. No needle is inserted into the patient. The researcher will monitor the child's pain and fear levels during this time. Parents and observers will be asked to rate their fear/anxiety levels on the CFS scale before, during, and after the procedure, while children will be asked to do the same before and after. The child's post-procedure pain level (WB-FACES scale) will be assessed by the child themselves, as well as by the parent and observer. The scales will be evaluated independently and simultaneously, and the results will be recorded on a form.
No invasive procedure will be performed on the child. All these procedures will take approximately 5-10 minutes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Selda ATES BESIRIK, PhD. Study Principal Investigator, Assist. Prof.
- Phone Number: +905543683323
- Email: seldaates07@gmail.com
Study Contact Backup
- Name: Selda ATES BESIRIK, PhD.
- Email: seldaates07@gmail.com
Study Locations
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Burdur, Turkey (Türkiye)
- Recruiting
- Burdur Mehmet Akif Ersoy University
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Contact:
- Selda ATES BESIRIK, PhD.
- Phone Number: +905543683323
- Email: seldaates07@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering of the child and parent to participate in the study,
- Children the ages between 5-10,
- Having intramuscular (IM) injection.
Exclusion Criteria:
- Communication problem,
- Children with any chronic illness,
- Taking any medication that has an analgesic effect at least 6 hours before applying.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Vibration Group
Vibration was applied to the children in this group before and during the intramuscular Injection procedure.
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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.
Other Names:
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Experimental: Shotblocker Group
ShotBlocker was applied to the children in this group before and during the intramuscular Injection procedure.
|
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.
Other Names:
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No Intervention: Control Group
In this group, child received routine intramuscular Injection procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wong-Baker FACES Pain Rating Scale
Time Frame: Through painful procedure completion, an average of 10 minutes
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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.
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Through painful procedure completion, an average of 10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Fear Scale
Time Frame: Through painful procedure completion, an average of 10 minutes.
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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).
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Through painful procedure completion, an average of 10 minutes.
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Collaborators and Investigators
Investigators
- Principal Investigator: Selda A ATES BESIRIK, PhD., Burdur Mehmet Akif Ersoy University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 2026/2536
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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