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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Being outside the age range of 3-17
Patient's medical condition;
Implementation of interventions/treatments that will affect the measurement;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hilal Yilmaz | Contact | +905452904665 | hilal.yilmaz2@ogr.iuc.edu.tr | |
| Aylin Ozakgul | Contact | +905320655170 | aylin.ozakgul@iuc.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Hilal Yilmaz | Istanbul University - Cerrahpasa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Recruiting | Istanbul | Avcilar | 34320 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27050739 | Result | 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. | |
| 21245075 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2022 |
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Randomized controlled experimental study
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|
| 31848034 | 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. |
| 25067984 | 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. |
| 16060582 | Result | Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94. |
| 12127221 | 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. |
| 1937522 | 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. |
| 7930099 | 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. |
| 10325708 | 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. |
| 2029821 | 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. |
| 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. |
| Dec 8, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2022 | Dec 8, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C034430 | methyl hydroxyethyl cellulose |
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