An interventional study of The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer in Body Temperature Changes, sponsored by Istanbul University - Cerrahpasa. Recruiting at 1 site in Turkey. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Other
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.
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.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's planned enrollment of 68 is above the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
Patient's medical condition;
Implementation of interventions/treatments that will affect the measurement;
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
Controlled group: We will not position the auricula first while taking body temperature. And then we will position the auricula back and up.
The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer
Body temperature changes with or without positioning the auricula in pediatric patients.
We will measure the body temperature with tympanic thermometer and will use the Celcius as a measure of unit.
Time frame: 2 minutes
Level of comfort changes (by using Comfort Daisies) with or without positioning the auricula in pediatric patients.
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".
Time frame: 2 minutes
Level of comfort changes (by using Visual Analogue Scale) with or without positioning the auricula in pediatric patients.
We will use VAS (Visual Analogue Scale).Visual Analogue Scale is between 0 to 10.
Time frame: 2 minutes
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Dec 2022 (actual). Primary completion is estimated for Mar 2024, 15 months after the start.
Of 44 non-industry interventional studies with no phase under Body Temperature Changes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 15 months is above that.
Counting every sponsor, half of 44 studies reached it within 5 months; a quarter within 3 and three quarters within 21.
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