Relationship-based Care Model in Pediatrics

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199429
• Other study ID #: UniUrb
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: December 2019
• Source: University of Urbino "Carlo Bo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Nurse-Patient Relations

Intervention

Behavioral:
• Relationship-Based Care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Urbino "Carlo Bo"	University of Padua

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	T2: at discharge of the patient (expected mean value = 6.2 days after admission [standard deviation = 2.0])
Secondary	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.	6 months