NCT06872476

Brief Summary

Study Overview: This randomized cross-over study investigated the effects of bed baths on the vital signs and blood gas values of children. The children received two bed baths: one under a heater and the other at room temperature. The order of the bed baths was randomized. Methods: The study involved children aged 1-36 months hospitalized in the Pediatric Intensive Care Unit (PICU). The bed baths were administered by a research nurse and assistant staff between 16:00 and 24:00 on weekends. The vital signs and capillary blood gas values (pH, PaO2, PaCO2, HCO3-) were measured three times: before, immediately after, and one hour after the bath. Data on heart rate, blood pressure, SpO2, and blood gas values were collected using specialized equipment. Heating and Bathing Process: For the heated bed bath, two heaters were positioned 50-60 cm above the child's bed, and the bath was conducted using soapy water at 37-40°C, followed by clear water. Population: The study was conducted in the PICU of a children's hospital, including children aged 1-36 months who were on mechanical ventilation, had normal body temperatures, and did not have chronic diseases. A total of 12 children participated over a period of two years. Statistical Analysis: Data were analyzed using IBM SPSS Statistics. Descriptive statistics such as percentages, averages, and standard deviations were used. The normality of the data was assessed, and repeated measurements were analyzed using ANOVA.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

December 15, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

February 25, 2025

Last Update Submit

March 7, 2025

Conditions

Keywords

bed bathblood gasesmechanical ventilatorpediatric intensive carevital signs

Outcome Measures

Primary Outcomes (8)

  • temperature measure

    Celcius

    The bady temperature values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.

  • Pulse

    per minute

    The heart pulse values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.

  • blood pressure

    mmHg

    The blood pressure values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.The values were measured three times in each bed bath, for a total of six times.

  • oxygen saturation

    The oxygen saturation values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.

  • blood pH

    pH

    The capillary blood pH values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.

  • PaO2

    The capillary blood PaO2 values were evaluated for total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.

  • PaCO2

    The capillary blood PaCO2 values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.The values were measured three times in each bed bath, for total of six times.

  • HCO3-

    mEq/L

    The capillary blood HCO3- values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bathThe values were measured three times in each bed bath, for total of six times.

Study Arms (2)

bed bath

EXPERIMENTAL

This practice is a complementary and supportive care intervention.

Other: bed bathOther: bed bath with heat

bed bath with heat

EXPERIMENTAL

This practice is a complementary and supportive care intervention.In detail, this bed baths which were performed at under two heaters located 50-60 centimeters away from the bed of the children.

Other: bed bathOther: bed bath with heat

Interventions

bed bathbed bath with heat
bed bathbed bath with heat

Eligibility Criteria

Age2 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who are hospitalized for respiratory failures and in mechanical ventilators,
  • having normal body temperatures

You may not qualify if:

  • Total Parenterally Nutrition
  • any chronic diseases
  • any disease or condition which bathing would cause problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kzl H, Sendir M. The Effects of Bed Bathing on Vital Signs and Oxygen Saturation in Children Who Are Connected to Mechanical Ventilation. Dimens Crit Care Nurs. 2018 Sep/Oct;37(5):272-278. doi: 10.1097/DCC.0000000000000312.

    PMID: 30063523BACKGROUND

MeSH Terms

Interventions

Hot Temperature

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof Zübeyde KORKMAZ, Principal Investigator Pediatric Nursing, Department of Nursing, Faculty of Health Science.

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 12, 2025

Study Start

December 15, 2015

Primary Completion

December 30, 2017

Study Completion

March 15, 2018

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share