The Effects of Vibration and Pressure Interventions

NCT05656066 | Completed

• 1 other identifier: ıntramuscular
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety

Keywords

anxiety; fear; pain

Outcome Measures

Primary Outcomes (3)

• 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, \& 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

  during procedure

• 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 (β = 0.340, p \< .001).

  during procedure

• 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

Study Arms (3)

The Vibration Intervention Group (VI)

EXPERIMENTAL

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.

Behavioral: The Vibration Intervention

The Pressure Intervention Group

EXPERIMENTAL

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

Behavioral: The Pressure Intervention

The Control Group

NO INTERVENTION

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

Interventions

The Vibration Intervention BEHAVIORAL

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 Vibration Intervention Group (VI)

The Pressure Intervention BEHAVIORAL

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

The Pressure Intervention Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Hatice Uzşen

Samsun, Atakum, 55100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 19497458 BACKGROUND

• 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.

  PMID: 31588477 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which group in. Researcher and nurse will know.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled, and experimental design

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)