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The Effects of Vibration and Pressure Interventions

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Vibration Intervention
The Pressure Intervention
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring anxiety, fear, pain

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts 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

Sites / Locations

  • Hatice Uzşen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

The Vibration Intervention Group (VI)

The Pressure Intervention Group

The Control Group

Arm 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.

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

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

Outcomes

Primary Outcome Measures

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
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).
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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
December 9, 2022
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05656066
Brief Title
The Effects of Vibration and Pressure Interventions
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, fear, pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, and experimental design
Masking
Participant
Masking Description
Participants will not know which group in. Researcher and nurse will know.
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Vibration Intervention Group (VI)
Arm Type
Experimental
Arm 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.
Arm Title
The Pressure Intervention Group
Arm Type
Experimental
Arm 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
Arm Title
The Control Group
Arm Type
No Intervention
Arm Description
The routine IM injection was applied to the children in the control group.
Intervention Type
Behavioral
Intervention Name(s)
The Vibration Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Pressure Intervention
Intervention Description
Pressure was placed in the ıntramuscular area properly 30 seconds before injection. Then the injection process was completed.
Primary Outcome Measure Information:
Title
Children's Fear Scale (CFS)
Description
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
Time Frame
during procedure
Title
The Children's Anxiety Meter-State (CAM-S)
Description
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).
Time Frame
during procedure
Title
Wong-Baker FACES Rating Scale
Description
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.
Time Frame
during procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hatice Uzşen
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19497458
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.
Results Reference
background
PubMed Identifier
31588477
Citation
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.
Results Reference
background

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The Effects of Vibration and Pressure Interventions

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