NCT05656066

The Effects of Vibration and Pressure Interventions

The Effects of Vibration and Pressure Interventions on Pain, Fear and Anxiety in Pediatric Patients Coming to the Emergency Department for Intramuscular Injection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Ondokuz Mayıs University · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	The Pressure Intervention	Pressure was placed in the ıntramuscular area properly 30 seconds before injection. Then the injection process was completed.

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-09-01
• Completion: 2022-10-01
• First posted: 2022-12-19
• Last updated: 2022-12-19

Locations

1 site across 1 country: Turkey (Türkiye)