The Effects of Vibration and Pressure Interventions

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656066
• Other study ID #: intramuscular
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2022
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.
• The Pressure Intervention
Pressure was placed in the intramuscular area properly 30 seconds before injection. Then the injection process was completed.

Locations

Country	Name	City	State
Turkey	Hatice Uzsen	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Fear Scale (CFS)	The 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, & Bektas, 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	during procedure
Primary	The Children's Anxiety Meter-State (CAM-S)	The 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 (ß = 0.340, p < .001).	during procedure
Primary	Wong-Baker FACES Rating Scale	It 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.	during procedure