The Effects of Vibration and Pressure Interventions

Ondokuz Mayıs University

Status: Completed

Conditions: Anxiety

Treatments: Behavioral: The Pressure Intervention; Behavioral: The Vibration Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05656066

ıntramuscular

Details and patient eligibility

About

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

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 3 patient groups

The Vibration Intervention Group (VI)

Experimental group

Description:

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.

Treatment:

Behavioral: The Vibration Intervention

The Pressure Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: The Pressure Intervention

The Control Group

No Intervention group

Description:

The routine IM injection was applied to the children in the control group.