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

NCT ID: NCT06175975

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-03-22

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.

Conditions

Body Temperature Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Hilal Yilmaz

Master's degree student of Fundamentals of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hilal Yilmaz

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, Avcilar, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hilal Yilmaz

Role: CONTACT

hilal.yilmaz2@ogr.iuc.edu.tr

+905452904665

Aylin Ozakgul

Role: CONTACT

aylin.ozakgul@iuc.edu.tr

+905320655170

Facility Contacts

Hilal Yilmaz

Role: primary

hilal.yilmaz2@ogr.iuc.edu.tr

+905452904665

Aylin Ozakgul

Role: backup

aylin.ozakgul@iuc.edu.tr

+905320655170

References

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.

Reference Type: RESULT

PMID: 27050739 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21245075 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31848034 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25067984 (View on PubMed)

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

Reference Type: RESULT

PMID: 16060582 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12127221 (View on PubMed)

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.

Reference Type: RESULT

PMID: 1937522 (View on PubMed)

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.

Reference Type: RESULT

PMID: 7930099 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10325708 (View on PubMed)

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.

Reference Type: RESULT

PMID: 2029821 (View on PubMed)

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.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IUC-Hyilmaz-001

Identifier Type: -

Identifier Source: org_study_id