The Effect of Auricular Position on Measurement Values and Comfort in Measuring Body Temperature by Tympanic Method in Pediatric Patients

December 8, 2023 updated by: Hilal Yilmaz, Istanbul University - Cerrahpasa (IUC)
The focus of the clinical research is to examine whether there is a difference in body temperature measurements with or without positioning the auricle in the measurements made with a tympanic membrane thermometer in pediatric patients aged 3-17, and to examine the effect of positioning the ear on comfort behaviors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is the nurses' responsibility to monitor vital signs including body temperature, pulse, respiration and blood pressure. Ideal body temperature measurement; It should be a method that is reliable, easy, fast, low-cost, best showing the internal temperature of the body and least affected by environmental conditions. Measurement by the tympanic route; It is a method that is frequently preferred because it gives the correct value, measures the internal temperature, and is not affected by oral nutrition and fluid intake. While the measurement in a few seconds saves nurses time, it is also stated that it is more comfortable for patients than other thermometers.Tympanic membrane thermometers measure the temperature of the blood passing through the tympanic membrane in the ear with infrared radiation.If the tip of the thermometer cannot see the tympanic membrane (eardrum), erroneous results may occur. For this reason, the pinna position where the tip of the tympanic thermometer is placed is very important. It has been stated that in pediatric patients, due to the anatomical structure difference compared to adult patients, measurements should be made by placing them in a downward position. In studies conducted with children and newborns, there are different results in the evidence regarding the effect of auricular position on the measurement value. For this reason, this research is planned to determine the effect of auricular position on body temperature measurement values and comfort behaviors by using Visual Analogue Scale (VAS) and age-appropriate Comfort Daisies developed by Katharine Kolcaba in measurements made with a tympanic membrane thermometer in pediatric patients aged 3-17 years. With the results obtained from this study, it will be evaluated how the auricle position affects the measurement values and comfort behaviors in measuring body temperature by tympanic way in pediatric patients aged 3-17 years. It is thought that the results of this study will contribute to nursing practices and research.

Hypotheses:

H0: There is no significant difference between the body temperature measurement value, VAS score and comfort score performed without pulling the auricle, and the body temperature measurement value, VAS score and comfort score performed by pulling the auricle.

H1: There is a significant difference between the comfort behavior score in the measurement made without pulling the auricle and the comfort behavior score in the measurement made by pulling the auricle.

H2: There is a significant difference between the body temperature measurement value made without pulling the auricle and the body temperature measurement value made by pulling the auricle in patients.

Comparison Hypothesis:

H0: The body temperature measurement value without pulling the auricle, the body temperature measurement value made by pulling the auricle, the VAS score and the comfort score do not differ significantly according to socio-demographic characteristics (age, gender, etc.) and environment.

H1: In patients, the body temperature measurement value without pulling the auricle, the body temperature measurement value made by pulling the auricle, the VAS score and the comfort score show significant differences according to socio-demographic characteristics (age, gender, etc.) and environment.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Being between the ages of 3-17
  2. Receiving inpatient care/treatment in the Pediatric Intensive Care Clinic
  3. For the pediatric patient, the parents' willingness to participate in the study

Exclusion Criteria:

  1. Being outside the age range of 3-17

  2. Patient's medical condition;

    • Being sedated or unconscious,
    • Being intubated or tracheostomized,
    • Have had a head injury,
    • Have an ear disease, have an trauma/surgery,
    • Have an ear discharge, ear infection,
    • Have sepsis.

  3. Implementation of interventions/treatments that will affect the measurement;

    • Application of treatment (drops) by ear,
    • Last antipyretic treatment taken before 4 hours,
    • Before and during body temperature measurement, interventions (hot and cold application, blood transfusion, hemodialysis and plasma exchange) that will affect the measurement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular position
Experimental group: We will position the auricula back and up first while taking body temperature in pediatric patients. And then we will take body temperature without positioning.
Other: The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer
The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer
No Intervention: Without auricular position
Controlled group: We will not position the auricula first while taking body temperature. And then we will position the auricula back and up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body temperature changes with or without positioning the auricula in pediatric patients.
Time Frame: 2 minutes
We will measure the body temperature with tympanic thermometer and will use the Celcius as a measure of unit.
2 minutes
Level of comfort changes (by using Comfort Daisies) with or without positioning the auricula in pediatric patients.
Time Frame: 2 minutes
We will use Comfort Daisies. Comfort Daisies has 4 daisies which include the expressions like "very good, sort of good, sort of bad and very bad".
2 minutes
Level of comfort changes (by using Visual Analogue Scale) with or without positioning the auricula in pediatric patients.
Time Frame: 2 minutes
We will use VAS (Visual Analogue Scale).Visual Analogue Scale is between 0 to 10.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Hilal Yilmaz, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

March 22, 2024

Study Completion (Estimated)

March 22, 2024

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUC-Hyilmaz-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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