Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05656066
Enrollment
114
Registered
2022-12-19
Start date
2022-08-01
Completion date
2022-10-01
Last updated
2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

anxiety, fear, pain

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.

Interventions

BEHAVIORALThe 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.

BEHAVIORALThe Pressure Intervention

Pressure was placed in the ıntramuscular area properly 30 seconds before injection. Then the injection process was completed.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants will not know which group in. Researcher and nurse will know.

Intervention model description

Randomized, controlled, and experimental design

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Children's Fear Scale (CFS)during procedureThe Children's Fear Scale (CFS) is a scale used to assess the level of anxiety in children. The scale is a visual measurement tool with scores ranging from 0-4 points. It consists of five facial expressions, ranging from a neutral to a frightened expression, and is suitable for use with children aged 5-10 years (Inan & Inal, 2019; McMurtry, Noel, Chambers, & McGrath, 2011; Özalp Gerçeker, Ayar, Özdemir, & Bektaş, 2018). The evaluation of the Turkish psychometric properties of the scale, which was developed by McMurty et al. for paediatric patients, was conducted by Özalp Gerçeker et al. (2018), and the scale was translated into the Turkish language (Özalp Gerçeker et al., 2018). The CFS has demonstrated good evidence of test-retest (r = 0.76, p \< 0.001), and inter-rater (0.51, P \< 0.001) reliability, as well as construct validity, (rs ¼ when used with children (McMurtry vd., 2011
The Children's Anxiety Meter-State (CAM-S)during procedureThe Children's Anxiety Meter-State (CAM-S) assesses children's anxiety at medical procedures. It is drawn like a thermometer with a bulb at the bottom. It includes horizontal lines going up to the top (0-10). Children are asked to mark their feelings right now to measure state anxiety (Kleiber & Mccarthy, 2006). CAM-S was validated in children aged 4-10 years during an intravenous procedure. It is significantly associated with all parent measures and observed distress ratings (Ersig et al., 2013). Gerçeker et al. (2018) conducted the psychometric properties of CAM-S in the Turkish population. They revealed a significant negative correlation between the CAM-S scores and children's ages (β = 0.340, p \< .001).
Wong-Baker FACES Rating Scaleduring procedureIt is a horizontal scale developed by Wong and Baker in 1983 for children over 3 years of age who can express themselves. In this scale, pain scores are given to faces according to numerical values. The lowest score is 0 and the highest score is 10. As the score obtained from the scale increases, the severity of pain increases. During the application of the scale, it is stated to the child that each of the facial expressions belongs to a person. It is stated that the child who has no pain expresses a happy face, while the child who has a little or a lot of pain during the procedure has sad faces.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026