- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06654479
The Effect of Nursing Interventions on Body Temperatures of Infants
The Effect of Location and Duration of Nursing Interventions on Body Temperatures of Infants in the Neonatal Intensive Care Unit
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Çi̇ğli̇
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İ̇zmi̇r, Çi̇ğli̇, Turkey, 35620
- İzmir Katip Çelebi University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
The study included neonates treated in the neonatal intensive care unit.
In the newborns in the study, changes in body temperatures during routine nursing interventions of the nurses of the clinic were examined.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body temperature of newborns
Time Frame: The study was completed in 17 months.
|
Changes in body temperature of neonates during routine interventions by nurses
|
The study was completed in 17 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22.09.2022/0380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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