Relationship-based Care Model in Pediatrics

N/ACompletedNCT04199429

University of Urbino "Carlo Bo"180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

180

Conditions

Depression, Anxiety Nurse-Patient Relations

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

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])

Secondary Outcomes

Caring Behaviors Inventory (CBI)

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.

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

Change of the job satisfaction of the nurses

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.

Time frame: 6 months