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

NCT06175975 | Unknown

• 1 other identifier: IUC-Hyilmaz-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Temperature Changes

Keywords

Auricular position; Comfort; Pediatric patients

Outcome Measures

Primary Outcomes (3)

• 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.

  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".

  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.

  2 minutes

Study Arms (2)

Auricular position

EXPERIMENTAL

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

Without auricular position

NO INTERVENTION

Controlled group: We will not position the auricula first while taking body temperature. And then we will position the auricula back and up.

Interventions

The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer OTHER

The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer

Auricular position

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Being outside the age range of 3-17
• 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.
• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Avcilar, 34320, Turkey (Türkiye)

RECRUITING

Related Publications (11)

• Oguz F, Yildiz I, Varkal MA, Hizli Z, Toprak S, Kaymakci K, Saygili SK, Kilic A, Unuvar E. Axillary and Tympanic Temperature Measurement in Children and Normal Values for Ages. Pediatr Emerg Care. 2018 Mar;34(3):169-173. doi: 10.1097/PEC.0000000000000693.

  PMID: 27050739 RESULT

• Uslu S, Ozdemir H, Bulbul A, Comert S, Bolat F, Can E, Nuhoglu A. A comparison of different methods of temperature measurements in sick newborns. J Trop Pediatr. 2011 Dec;57(6):418-23. doi: 10.1093/tropej/fmq120. Epub 2011 Jan 18.

  PMID: 21245075 RESULT

• Dante A, Franconi I, Marucci AR, Alfes CM, Lancia L. Evaluating the Interchangeability of Forehead, Tympanic, and Axillary Thermometers in Italian Paediatric Clinical Settings: Results of a Multicentre Observational Study. J Pediatr Nurs. 2020 May-Jun;52:e21-e25. doi: 10.1016/j.pedn.2019.11.014. Epub 2019 Dec 14.

  PMID: 31848034 RESULT

• Allegaert K, Casteels K, van Gorp I, Bogaert G. Tympanic, infrared skin, and temporal artery scan thermometers compared with rectal measurement in children: a real-life assessment. Curr Ther Res Clin Exp. 2014 May 8;76:34-8. doi: 10.1016/j.curtheres.2013.11.005. eCollection 2014 Dec.

  PMID: 25067984 RESULT

• Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.

  PMID: 16060582 RESULT

• Kocoglu H, Goksu S, Isik M, Akturk Z, Bayazit YA. Infrared tympanic thermometer can accurately measure the body temperature in children in an emergency room setting. Int J Pediatr Otorhinolaryngol. 2002 Aug 1;65(1):39-43. doi: 10.1016/s0165-5876(02)00129-5.

  PMID: 12127221 RESULT

• Kolcaba KY. A taxonomic structure for the concept comfort. Image J Nurs Sch. 1991 Winter;23(4):237-40. doi: 10.1111/j.1547-5069.1991.tb00678.x.

  PMID: 1937522 RESULT

• Kolcaba KY. A theory of holistic comfort for nursing. J Adv Nurs. 1994 Jun;19(6):1178-84. doi: 10.1111/j.1365-2648.1994.tb01202.x.

  PMID: 7930099 RESULT

• Childs C, Harrison R, Hodkinson C. Tympanic membrane temperature as a measure of core temperature. Arch Dis Child. 1999 Mar;80(3):262-6. doi: 10.1136/adc.80.3.262.

  PMID: 10325708 RESULT

• Pransky SM. The impact of technique and conditions of the tympanic membrane upon infrared tympanic thermometry. Clin Pediatr (Phila). 1991 Apr;30(4 Suppl):50-2; discussion 60. doi: 10.1177/0009922891030004S15. No abstract available.

  PMID: 2029821 RESULT

• Orkun N, Eser I. The Effect of Pinna Position on Body Temperature Measurements Made with a Tympanic MembraneThermometer in Pediatric Patients. J Pediatr Res. 2020;7(2):132-8.

  RESULT

MeSH Terms

Conditions

Body Temperature Changes

Interventions

methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilal Yilmaz

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Yilmaz

CONTACT

+905452904665; hilal.yilmaz2@ogr.iuc.edu.tr

Aylin Ozakgul

CONTACT

+905320655170; aylin.ozakgul@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student of Fundamentals of Nursing

Model Details: Randomized controlled experimental study

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: December 19, 2023
• Study Start: December 1, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

TU (1)