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Completed

NCT Number: NCT07183553

The Effect of a Family-Centered Care Approach on Infants Receiving High-Flow Nasal Oxygen Therapy

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

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hitit University

Çorum, Merkez, 19030, Turkey (Türkiye)

About this study

The population of the study consisted of babies and their mothers who were receiving high-flow nasal oxygen therapy in the baby wards of Ankara Etlik City Hospital between December 2024 and March 2025.After receiving written consents with the volunteer consent form from the mothers who agreed to participate in the study, the volunteers were divided into intervention and control groups using the "computerized randomization method" (www.randomizer.org ). Patients were distributed to two groups according to the randomization list and all groups were informed about how to fill out follow-up forms. In both groups, the data in the section on introductory characteristics of the mother and baby in the first part of the Mother and Baby Introductory Information Form were filled in. A pre-test was administered with the family-centered care scale. The data related to the measurements of life signs (body temperature, pulse, respiration, oxygen saturation and blood pressure) contained in the introductory characteristics section of the baby were obtained from the patient's file and recorded. The intervention group received the "Family-Centered Care Program" and the control group received the standard care program of the clinic.The families in the intervention group were given training and information about family-centered care and were given an educational booklet that had been prepared. Before discharge, a post-test was conducted on both groups using the family-centered care scale.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 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.

Exclusion criteria

  • 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.

Treatment and study plan

maintenance training

Other

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

Primary outcomes

  1. Family Centred Care Scale

    Time frame: three days

    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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

The Effect Of Family-Centered Care Approach On Physiological Parameters And Follow-Up Tıme In Infants Receiving Hıgh-Flow Nasal Oxygen Therapy Wıth The Diagnosis Of Lower Respiratory Tract Infection

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

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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