Clinical trial NCT05656066: The Effects of Vibration and Pressure Interventions
Official title: The Effects of Vibration and Pressure Interventions on Pain, Fear and Anxiety in Pediatric Patients Coming to the Emergency Department for Intramuscular Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
fear
pain
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 114
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, and experimental design
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate two methods (pressure and vibration intervention) used to reduce pain during IM injections in children.

Detailed description: Objectives: This study was conducted to evaluate the effects of the Vibration and Pressure Intervention for reducing pain during intramuscular (IM) injections in children.

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.

Eligibility criteria: Inclusion Criteria:

* had no diagnosed physical or mental disability or chronic illness;
* 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:

* Parents who were unable to collaborate in the fear and pain evaluation,
* 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

Primary outcomes:
measure: Children's Fear Scale (CFS)
timeFrame: during procedure
measure: The Children's Anxiety Meter-State (CAM-S)
timeFrame: during procedure
measure: Wong-Baker FACES Rating Scale
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Hatice Uzşen
state: Atakum
Study officials:
References:
citation: 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.
citation: 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.