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Completed

NCT Number: NCT06654479

The Effect of Nursing Interventions on Body Temperatures of Infants

Aim: This study planned the intervention and care of term and preterm newborns treated in neonatal intensive care units, including thermoregulation, procedure duration and care with the opening technique of incubator covers.

Method: This non-participatory observational study was conducted between October 2022 and December 2023 with a total of 104 term and preterm newborns who were being treated in the Neonatal Intensive Care Unit of S.B.U. Dr. Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Izmir, Turkey. In the study, the Case Report Form prepared by the researcher and based on the research method, dependent/independent variables and inclusion/exclusion criteria was used to collect data. The opening techniques of incubator lids were determined as double intervention window open, single intervention window open and incubator lid fully open. After selected newborns who met the inclusion/exclusion criteria, standardisation was ensured by explaining to the nurse who would provide care and intervention the location of the heat probe (right abdominal region) and that the patient should be in the supine position. The incubator temperature, incubator humidity, body temperature and neonatal intensive care room temperature and humidity before the procedure, the technique of opening the incubator lid during the care delivery phase and the intervention applied were recorded on the Case Report Form.

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Key information

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

İzmir Katip Çelebi University

Izmir, Çi̇ğli̇, 35620, Turkey (Türkiye)

About this study

Aim: This study planned the intervention and care of term and preterm newborns treated in neonatal intensive care units, including thermoregulation, procedure duration and care with the opening technique of incubator covers.

Method: This non-participatory observational study was conducted between October 2022 and December 2023 with a total of 104 term and preterm newborns who were being treated in the Neonatal Intensive Care Unit of S.B.U. Dr. Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Izmir, Turkey. In the study, the Case Report Form prepared by the researcher and based on the research method, dependent/independent variables and inclusion/exclusion criteria was used to collect data. The opening techniques of incubator lids were determined as double intervention window open, single intervention window open and incubator lid fully open. After selected newborns who met the inclusion/exclusion criteria, standardisation was ensured by explaining to the nurse who would provide care and intervention the location of the heat probe (right abdominal region) and that the patient should be in the supine position. The incubator temperature, incubator humidity, body temperature and neonatal intensive care room temperature and humidity before the procedure, the technique of opening the incubator lid during the care delivery phase and the intervention applied were recorded on the Case Report Form. The researcher monitored the duration of the procedure with a chronometer at the beginning of the procedure. Body temperature, incubator temperature.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In the neonatal intensive care unit,
  • History of mature and premature birth (≤37 GH),
  • Definitive diagnosis known,
  • Newborns treated in a single brand of incubator, as different brands of incubators may vary in opening the lids and heating the incubators according to the characteristics of the incubator.

Exclusion criteria

  • Diagnosed with asphyxia and receiving therapeutic cooling treatment,
  • Within 10 days postoperatively,
  • Active fever or a diagnosis of sepsis,
  • Intervened under the radiant heater,
  • Clinical condition deteriorated during the study period,
  • Newborns who are followed and clothed to be placed with their mother.

Treatment and study plan

In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.

Other

The study is an observational study. The newborns were not intervened by the researcher. Body temperature changes were observed during routine practices of nurses in the clinic.

Primary outcomes

  1. Body temperature of newborns

    Time frame: The study was completed in 17 months.

    Changes in body temperature of neonates during routine interventions by nurses

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

The Effect of Location and Duration of Nursing Interventions on Body Temperatures of Infants in the Neonatal Intensive Care Unit

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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