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Completed

NCT Number: NCT04199429

Relationship-based Care Model in Pediatrics

Aim: To evaluate whether the application of the Relationship-based Care (RBC) model as a treatment called "Take 5 minutes" (T5M) affects the level of anxiety and depression of the parent, the level of the parent perceived quality of nursing care and the work satisfaction of the nursing staff.

Design: Single-blind randomized controlled trial.

Methods: The trial was performed from February to July 2016. The trial was conducted with one intervention (N=101) and one control group (N=90). Nurses applied the RBC model as a treatment, named "Take 5 Minutes", that consisted of dedicating some short time (from 5 to 10 minutes) to the relationship with the parents, using specifically designed communication strategies. The primary outcome was the evaluation of anxiety and depression of parents, the secondary was the parent perceived quality of nursing care.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Nurse-Patient Relations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the parents of the children admitted to two Pediatric Units in a nationally renowned university hospital in the North-East of Italy
  • had knowledge of the Italian language spoken and written
  • were available for participation in the study by signing the informed consent

Exclusion criteria

  • Parents of hospitalized patients for a duration of less than 4 days

Treatment and study plan

Relationship-Based Care

Behavioral

Primary outcomes

  1. Change from T0 to T1 and T2 of the Hospital Anxiety and Depression Scale (HADS) scores

    Time frame: T0: admission of the patient; T1: 4th day after the admission; T2: at discharge (expected mean value = 6.2 days after admission [standard deviation = 2.0])

    The Hospital Anxiety and Depression Scale (HADS) has been used to determine the anxiety and depression of the parents of hospitalized children. HADS is a fourteen items scale (seven items related to anxiety and seven to depression): each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A cut-off point of 8/21 for anxiety or depression has been previously established in the literature.

Secondary outcomes

  1. Caring Behaviors Inventory (CBI)

    Time frame: T2: at discharge of the patient (expected mean value = 6.2 days after admission [standard deviation = 2.0])

    The Caring Behaviors Inventory (CBI) was used to assess the quality of nursing care perceived by the parents. CBI has 24-items, divided into four dimensions: presence, compliance, competence, and care; each item is a Likert-scale ranging from 0 to 4.

  2. Change of the job satisfaction of the nurses

    Time frame: 6 months

    A "Job Satisfaction" questionnaire was used to measure the job satisfaction of the nurses. This questionnaire is composed by 44-items. It was assessed at the beginning (February 2016) and at the end (July 2016) of the data collection.

Sponsors and collaborators

Lead sponsor

University of Urbino "Carlo Bo"

Other

Collaborators

  • University of Padova

Registry information

Official study title

Relationship-based Care Model in Pediatrics: a Randomized Controlled Trial to Implement the Parents' Perception of Quality of Nursing Care

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2019
Registry last updated
Dec 13, 2019

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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