NCT04337229

Brief Summary

This study; It will be carried out with the aim of developing the artificial intelligence method, which allows automatic determination of comfort levels of newborns.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 2, 2020

Last Update Submit

April 9, 2020

Conditions

NewbornComfortNursingArtificial Intelligence

Keywords

newborncomfortnursingartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Images of the newborn

    Images will be taken to transfer behaviors of newborns to the computer. Attention will be paid to making face and body movements visible while taking the image.The camera will take 12 hours of view of each newborn.However, this period can be shortened as a result of preliminary work.

    12 hours for each newborn

Secondary Outcomes (1)

  • Artificial intelligence techniques

    Approximately 1 week for each newborn

Study Arms (1)

artificial intelligence techniques

EXPERIMENTAL

Facial and body movements of newborns will be recorded by camera, and images will be processed in computer environment by using artificial intelligence techniques. As a result, it is planned to create a technology that determines the comfort level of the newborn quickly and simply and can be used by the mobile device.

Other: Artifical intelligent

Interventions

Artifical intelligentOTHER

it is planned to create a technology that determines the comfort level of the newborn quickly and simply, easy to use, time-saving and can be used by the mobile device.

artificial intelligence techniques

Eligibility Criteria

Age1 Hour - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents' acceptance of their baby's participation in the study
  • Having a baby born at 24-42 weeks

You may not qualify if:

  • Having a baby born before 24 weeks of gestation or after 42 weeks of gestation.
  • Has received analgesic, muscle relaxant or sedative drug treatment that may affect comfort and behavior (last 24 hours)
  • Newborn has serious neurological damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (29)

  • Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95.

    PMID: 1545324RESULT

  • Arroyo-Novoa CM, Figueroa-Ramos MI, Puntillo KA, Stanik-Hutt J, Thompson CL, White C, Wild LR. Pain related to tracheal suctioning in awake acutely and critically ill adults: a descriptive study. Intensive Crit Care Nurs. 2008 Feb;24(1):20-7. doi: 10.1016/j.iccn.2007.05.002. Epub 2007 Aug 6.

    PMID: 17689249RESULT

  • Arslan, H., & Konuk Şener, D. (2009). Stigma, spiritüalite ve konfor kavramlarının Meleis' in kavram geliştirme sürecine göre irdelenmesi. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 2(1): 51-58.

    RESULT

  • Atalay, M., & Çelik, E. (2017). Büyük veri analizinde yapay zekâ ve makine öğrenmesi uygulamaları. Mehmet Akif Ersoy Üniversitesi Sosyal Bilimler Enstitüsü Dergisi, 9(22): 155-172.

    RESULT

  • Aydın, Ş.E. (2017). Yapay zeka teknolojisi (yapay zekaların dünü bugünü yarını), Yüksek lisans tezi, Çukurova Üniversitesi, Adana.

    RESULT

  • Bodur, G., & Kaya, H. (2017). Hemşirelerin gözüyle gelecek: 2050'li yıllar. Ege Üniversitesi Hemşirelik Fakültesi Dergisi, 33 (1): 27-38.

    RESULT

  • Coughlin M, Gibbins S, Hoath S. Core measures for developmentally supportive care in neonatal intensive care units: theory, precedence and practice. J Adv Nurs. 2009 Oct;65(10):2239-48. doi: 10.1111/j.1365-2648.2009.05052.x.

    PMID: 19686402RESULT

  • Çınar Yücel Ş. (2011). Kolcaba'nın konfor kuramı. Ege Üniversitesi Hemşirelik Yüksek Okulu Dergisi, 27: 79-88.

    RESULT

  • Çimen, Ü. (2016). Solunum seslerinin yapay zekâ ortamında sınıflandırılması, Yüksek Lisans Tezi, Afyon Kocatepe Üniversitesi Fen Bilimleri Enstitüsü, Afyonkarahisar.

    RESULT

  • de Sousa Freire NB, Garcia JBS, Lamy ZC. Evaluation of analgesic effect of skin-to-skin contact compared to oral glucose in preterm neonates. Pain. 2008 Sep 30;139(1):28-33. doi: 10.1016/j.pain.2008.02.031. Epub 2008 Apr 22.

    PMID: 18434021RESULT

  • Hunter, J. (2010). Therapeutic positioning: neuromotor, physiologic, and sleep implications. Developmental care of newborns and infants. A guide for health professionals. 2nd edn. Glenview, IL: NANN: 283-312.

    RESULT

  • Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.

    PMID: 15636661RESULT

  • Kahraman, A., Başbakkal, Z., & Yalaz, M. (2014). Yenidoğan konfor davranış ölçeği'nin Türkçe geçerlik ve güvenirliği. Uluslararası Hakemli Hemşirelik Araştırmaları Dergisi, 1(2).

    RESULT

  • Karabacak, Ü., & Acaroğlu, R. (2011). Konfor kuramı. Maltepe Üniversitesi Bilim ve Sanat Dergisi, 4(1): 197-202.

    RESULT

  • Karakaplan, S., & Yıldız, H. (2010). Doğum sonu konfor ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1): 55-65.

    RESULT

  • Kaya, U., Yılmaz, A., & Dikmen, Y. (2019). Sağlık alanında kullanılan derin öğrenme yöntemleri. Avrupa Bilim ve Teknoloji Dergisi, (16): 792-808.

    RESULT

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

    PMID: 16060582RESULT

  • Kolcaba K, Tilton C, Drouin C. Comfort Theory: a unifying framework to enhance the practice environment. J Nurs Adm. 2006 Nov;36(11):538-44. doi: 10.1097/00005110-200611000-00010.

    PMID: 17099440RESULT

  • Kuğuoğlu, S., & Karabacak, Ü. (2008). Genel konfor ölçeğinin Türkçe'ye uyarlanması. İ.Ü.F.N. Hemşirelik Dergisi, 16 (61): 16-23.

    RESULT

  • Küçük Alemdar, D., & Güdücü Tüfekçi, F. (2015). Prematüre bebek konfor ölçeği'nin Türkçe geçerlilik ve güvenilirliği. Hemşirelikte Eğitim ve Araştırma Dergisi, 12 (2): 142-148.

    RESULT

  • Losacco V, Cuttini M, Greisen G, Haumont D, Pallas-Alonso CR, Pierrat V, Warren I, Smit BJ, Westrup B, Sizun J; ESF Network. Heel blood sampling in European neonatal intensive care units: compliance with pain management guidelines. Arch Dis Child Fetal Neonatal Ed. 2011 Jan;96(1):F65-8. doi: 10.1136/adc.2010.186429.

    PMID: 21177753RESULT

  • Mathai S, Natrajan N, Rajalakshmi NR. A comparative study of nonpharmacological methods to reduce pain in neonates. Indian Pediatr. 2006 Dec;43(12):1070-5.

    PMID: 17202604RESULT

  • Mijwel, M. M. (2015). History of artificial intelligence. Computer science, college of science, 1-6.

    RESULT

  • Sönmez, D. (2009). Pediatrik yoğun bakım ünitesinde endotrakeal aspirasyon ağrısının değerlendirilmes, Yüksek lisans tezi, Marmara Üniversitesi Sağlık Bilimleri Enstitüsü, İstanbul.

    RESULT

  • Terzi, B., Kaya, N. (2017). Konfor kuramı ve analizi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 20: 1.

    RESULT

  • Tutar Güven, Ş., & İşler Dalgıç, A. (2017). Prematüre yenidoğanlar için geliştirilmiş bireyselleştirilmiş destekleyici gelişimsel bakım programı. Uluslararası Hakemli Kadın Hastalıkları ve Anne Çocuk Sağlığı Dergisi, 9.

    RESULT

  • Uga E, Candriella M, Perino A, Alloni V, Angilella G, Trada M, Ziliotto AM, Rossi MB, Tozzini D, Tripaldi C, Vaglio M, Grossi L, Allen M, Provera S. Heel lance in newborn during breastfeeding: an evaluation of analgesic effect of this procedure. Ital J Pediatr. 2008 Nov 18;34(1):3. doi: 10.1186/1824-7288-34-3.

    PMID: 19490654RESULT

  • van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.

    PMID: 19692803RESULT

  • Yıldırım, T. (2019). Sağlıkta dönüşüm ve yapay zekânın pediatriye yansımaları. Karadeniz Pediatri Günleri Kongre Özet Kitabı, 2 (1): 1-97.

    RESULT

Study Officials

  • DENİZ YİĞİT, Res.Asst.

    ESKİŞEHİR OSMANGAZİ ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DENİZ YİĞİT, Res.Asst.

CONTACT

05428092848deniz.yigit@dpu.edu.tr

AYFER ACIKGOZ, Assoc.Dr.

CONTACT

05352919374ayferackgoz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Researchers and family of newborns will know about all the details of the study. Verbal and written permission will be obtained from families.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: it is planned to create a technology that determines the comfort level of the newborn quickly and simply, easy to use, time-saving and can be used by the mobile device.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 7, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

September 1, 2021

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

At the end of the study, it is aimed to announce the artificial intelligence developed to measure comfort with the declaration to be made in international congresses. In this way, it is thought that the program will be used by healthcare professionals in different hospitals and neonatal clinics in these hospitals.

Shared Documents
STUDY PROTOCOL
Time Frame
It will be shared after the study is finished (About 2 years later)
Access Criteria
Being a healthcare professional working with newborns