NCT07183553

Brief Summary

This research is an experimental study of randomized control with pre-test - post-test control group. The aim of this study is to determine the effect of family-centered care approach on physiological parameters and follow-up time in infants with respiratory failure diagnosed with lower respiratory tract infection and receiving high-current oxygen therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

July 9, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

Family-centered carehigh-flow nasal oxygen therapylower respiratory tract infectionrespiratory failurenursinginfant

Outcome Measures

Primary Outcomes (1)

  • Family Centred Care Scale

    The Family-Centered Care Scale (FCCS), consists of two sections. Both sections contain the same questions. The scale, divided into two sections for importance and consistency, consists of seven items. Each item is scored from 1 to 5. The lowest possible score is 7, and the highest is 35. As the total score increases, satisfaction with family-centered care increases in direct proportion to the score obtained from the scale. The items consist of questions regarding the evaluation of the nursing care received by parents during their hospital stay. The importance section evaluates the level of care shown by the nurses, and the consistency section evaluates the level of care shown by the nurses in the child's care. In the scale's evaluation, the importance and consistency scores are added together to form a single score.

    three days

Study Arms (2)

intervention group

After completing the data in the first section of the Mother and Baby Introductory Information Form, which includes information about the mother and baby, and the Family-Centered Care Scale, the mothers received one-on-one information, which lasted approximately 30 minutes, based on the content of the prepared education booklet. The education booklet covered topics on family-centered care, clinical equipment, steam application, and postural drainage. The mother was supported by a nurse throughout the care process until discharge. Maternal care practices were implemented under the supervision of the nurse, and questions about care were answered. The Family-Centered Care Scale was administered before discharge.

Other: maintenance training

control group

After completing the data in the first section of the Mother and Baby Information Form, which includes information about the mother and baby, and the Family-Centered Care Scale, the mothers were trained by the nurses in accordance with the standard training content of the service. This content included general service rules, general materials used in the service, and a service introduction. Families were also provided with basic information about high nasal flow, including what it means. Care practices were implemented by the nurse until discharge. The Family-Centered Care Scale was administered at discharge.

Interventions

information has been provided in accordance with the content of the training booklet.

intervention group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study included babies and their mothers who were treated in baby wards and received high-flow nasal oxygen therapy.

You may qualify if:

  • years of age or older,
  • Literate,
  • Agreeing to participate in the study,
  • Oriented to person, place, and time,
  • No visual (except for those with improved vision using visual aids) or auditory communication difficulties (except for those with improved hearing using hearing aids) that would prevent them from understanding and expressing the information provided,
  • No speech impairments/communication problems,
  • Mothers of infants aged 28 days to 2 years, receiving high-flow oxygen therapy due to a lower respiratory tract infection, and without any chronic disease.

You may not qualify if:

  • Mothers who did not speak or read Turkish,
  • who were participating in a different study conducted at the clinic, were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University

Çorum, Merkez, 19030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

July 9, 2025

First Posted

September 19, 2025

Study Start

December 1, 2024

Primary Completion

March 1, 2025

Study Completion

July 8, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations