Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2022-08-01
2022-10-01
Brief Summary
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Detailed Description
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Design: The study was conducted via a randomized controlled design. Setting: The study population consisted of children in the five to 10 age group admitted to the emergency department of a public hospital (Samsun Education and Research Hospital) between August 2022 and October 2022 and who received an IM injection as part of the medical treatment in child emergency department.
Interventions: The study data were collected from the children, who were divided into Vibration Intervention group, Pressure Intervention group, and control groups.
Main outcome measures: The children's pre-procedure fear and anxiety levels were evaluated using the Children's Fear Scale (CFS), and Children' Anxiety Meter State. Then, their pain levels during the procedure were evaluated using the Wong-Baker FACES Rating Scale.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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The Vibration Intervention Group (VI)
After the injection area was determined in the VI group, the vibration device was held for 30 seconds in the area to be injected, then the injection was applied by pulling up 3 cm while the device was operating.
The Vibration Intervention
The vibration frequency of the massager, which accelerates blood circulation, is 6000 / min, it works with a 1.5 volt battery. Can be used easily with one hand. The vibration simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.
The Pressure Intervention Group
After the injection area was determined in the PI group, 30 seconds light pressure was applied with the thumb and then the injection was given
The Pressure Intervention
Pressure was placed in the ıntramuscular area properly 30 seconds before injection. Then the injection process was completed.
The Control Group
The routine IM injection was applied to the children in the control group.
No interventions assigned to this group
Interventions
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The Vibration Intervention
The vibration frequency of the massager, which accelerates blood circulation, is 6000 / min, it works with a 1.5 volt battery. Can be used easily with one hand. The vibration simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.
The Pressure Intervention
Pressure was placed in the ıntramuscular area properly 30 seconds before injection. Then the injection process was completed.
Eligibility Criteria
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Inclusion Criteria
* had no communication problems;
* received single injection,
* required seftriakson group of antibiotics for standardization; and received vastus lateralis muscle injection during the study.
Exclusion Criteria
* overweight or underweight children (under the third or above the 97th percentile),
* children with any incision or scar tissue in the injection area,
* children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history
5 Years
10 Years
ALL
Yes
Sponsors
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Ondokuz Mayıs University
OTHER
Responsible Party
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Hatice Uzşen
Principal Investigator
Locations
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Hatice Uzşen
Samsun, Atakum, Turkey (Türkiye)
Countries
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References
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Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.
Bilge S, Aydin A, Gun C, Aldinc H, Acar YA, Yaylaci S, Cinar O, Balci V. Comparison of the efficacy of ShotBlocker and cold spray in reducing intramuscular injection-related pain in adults. A prospective, randomized, controlled trial. Saudi Med J. 2019 Oct;40(10):996-1002. doi: 10.15537/smj.2019.10.24322.
Other Identifiers
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ıntramuscular
Identifier Type: -
Identifier Source: org_study_id