Body Temperature ChangesNCT06175975
The Effect of Auricular Position on Measurement Values and Comfort in Measuring Body Temperature by Tympanic Method in Pediatric Patients
A study testing The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer in people with Body Temperature Changes, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, Avcilar, 34320
Hilal Yilmaz, +905452904665, hilal.yilmaz2@ogr.iuc.edu.tr
Aylin Ozakgul, +905320655170, aylin.ozakgul@iuc.edu.tr
About this study
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.
Read the 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
- Being tested
- The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer
- Keywords
- Auricular position, Comfort, Pediatric patients
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometerOther
The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Dec 2022
- Primary completion22 Mar 2024 (estimated)
- Study completion22 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Yilmaz, Istanbul University - Cerrahpasa
- Investigators
- Hilal Yilmaz, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175975
- Sponsor's protocol ID
- IUC-Hyilmaz-001
- Status last verified
- Dec 2023
- First submitted
- 6 Aug 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27050739Uslu 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.
PubMed 21245075Dante 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.
PubMed 31848034Allegaert 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.
PubMed 25067984Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.
PubMed 16060582Kocoglu 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.
PubMed 12127221Kolcaba 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.
PubMed 1937522Kolcaba 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.
PubMed 7930099Childs 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.
PubMed 10325708Pransky 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.
PubMed 2029821Orkun 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auricular Position on Measurement Values and Comfort in Measuring Body Temperature by Tympanic Method in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06175975
- Acronym / sponsor ID
- IUC-Hyilmaz-001
- Conditions
- Body Temperature Changes
- Keywords
- Auricular position, Comfort, Pediatric patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 22 Mar 2024 (estimated)
- Study completion
- 22 Mar 2024 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Auricular position | Experimental | Other: The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometerExperimental 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Being outside the age range of 3-17
- Patient's medical condition;
- Implementation of interventions/treatments that will affect the measurement;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometerThe effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer | Other | Auricular position |
Primary outcome
Body temperature changes with or without positioning the auricula in pediatric patients.
Time frame: 2 minutes
We will measure the body temperature with tympanic thermometer and will use the Celcius as a measure of unit.
Level of comfort changes (by using Comfort Daisies) with or without positioning the auricula in pediatric patients.
Time frame: 2 minutes
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".
Level of comfort changes (by using Visual Analogue Scale) with or without positioning the auricula in pediatric patients.
Time frame: 2 minutes
We will use VAS (Visual Analogue Scale).Visual Analogue Scale is between 0 to 10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Results publication: PubMed 27050739Oguz 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.
- Results publication: PubMed 21245075Uslu 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.
- Results publication: PubMed 31848034Dante 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.
- Results publication: PubMed 25067984Allegaert 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.
- Results publication: PubMed 16060582Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.
- Results publication: PubMed 12127221Kocoglu 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.
- Results publication: PubMed 1937522Kolcaba 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.
- Results publication: PubMed 7930099Kolcaba 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.
- Results publication: PubMed 10325708Childs 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.
- Results publication: PubMed 2029821Pransky 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.
- Results publicationOrkun 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Yilmaz principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The effect of placing the auricle position on the measurement values and comfort in measurements made with a tympanic membrane thermometer in people with Body Temperature Changes, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal Yilmaz (+905452904665, hilal.yilmaz2@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature changes with or without positioning the auricula in pediatric patients. (time frame: 2 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06175975, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.