Clinical trial NCT06175975: The Effect of Auricular Position on Measurement Values and Comfort in Measuring Body Temperature by Tympanic Method in Pediatric Patients
Official title: The Effect of Auricular Position on Measurement Values and Comfort in Measuring Body Temperature by Tympanic Method in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Temperature Changes
Keywords: Auricular position
Comfort
Pediatric patients
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled experimental study
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body temperature changes with or without positioning the auricula in pediatric patients.
timeFrame: 2 minutes
measure: Level of comfort changes (by using Comfort Daisies) with or without positioning the auricula in pediatric patients.
timeFrame: 2 minutes
measure: Level of comfort changes (by using Visual Analogue Scale) with or without positioning the auricula in pediatric patients.
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Avcilar
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Hilal Yilmaz
role: PRINCIPAL_INVESTIGATOR
References:
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