NCT05656950

Brief Summary

The research is a descriptive study designed to evaluate the oral health status of hospitalized children in pediatric intensive care units. The research was conducted between June 2021 and September 2021 in pediatric intensive care units in Izmir province. The patients were included in the study by using the cluster sampling method in the selection of the sample (n=88). Patient Identification Information Form and Oral Assessment Guide (OAG) were used for oral health assessment of patients. It was taken written consents from the hospitals where the research was carried out and from the relatives of the patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

December 10, 2022

Last Update Submit

December 10, 2022

Conditions

Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units

Keywords

Pediatric intensive care unitOral healthOral careOral health assessment

Outcome Measures

Primary Outcomes (1)

  • Assessing oral status of children in pediatric intensive care unit

    Oral health of the patient was evaluated using a flashlight and tongue depressor

    3 months

Study Arms (1)

Observed

Oral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide. Patient's age, gender, day of hospitalization in pediatric intensive care units, medical diagnosis/diagnoses, presence of chronic disease, state of consciousness, body temperature, oral care application method, oral care application frequency, oral care product used, amount taken/extracted, drugs used, albumin and haemoglobin data on values were obtained from the observation form of the patient.

Procedure: Assessment

Interventions

AssessmentPROCEDURE

Oral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide.

Observed

Eligibility Criteria

AgeUp to 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsUnder 18 ages
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Under 18 years old patients who are therapy in PICU

You may qualify if:

  • Being treated in the PICU
  • Parent's consent to participate in the study

You may not qualify if:

  • Applying non-invasive ventilation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramazan Bozkurt

Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (53)

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    RESULT

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    RESULT

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    RESULT

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    RESULT

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  • Bozkurt R, Eser I. Assessment of the Oral Health Status of Patients Admitted to Pediatric Intensive Care Units: A Cross-Sectional Study. Dimens Crit Care Nurs. 2024 Mar-Apr 01;43(2):53-60. doi: 10.1097/DCC.0000000000000625.

    PMID: 38271308DERIVED

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 10, 2022

First Posted

December 19, 2022

Study Start

June 20, 2021

Primary Completion

August 30, 2021

Study Completion

September 15, 2021

Last Updated

December 19, 2022

Record last verified: 2022-12

Locations

TU(1)