Relationship-based Care Model in Pediatrics

NCT04199429 | Completed

• 1 other identifier: UniUrb
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depression, Anxiety; Nurse-Patient Relations

Keywords

Relationship-based care; Pediatric; Caregiver anxiety; Nurse job satisfaction; Nurse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Caring Behaviors Inventory (CBI)

  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

  6 months

Study Arms (2)

Experimental

EXPERIMENTAL

Each nurse applied the RBC model through the treatment "Take 5 minutes" (T5M), to parents allocated to the experimental group. This consisted in devoting some time (from 5 to 10 minutes) to improving the relationship with the parent. This treatment can be considered as the practical development of the core principles of the RBC model by the study team. During the T5M the nurse applied the strategies of empathic communication and active listening, learned during the education and training phase. The treatment lasted from 5 to 10 minutes and was delivered once per day during the admission of the patient. The T5M time was considered as additional or supplementary, but not substitutive, of the standard nursing time dedicated daily to patients and parents.

Behavioral: Relationship-Based Care

Control

ACTIVE COMPARATOR

Standard nursing time dedicated daily to patients and parents.

Behavioral: Relationship-Based Care

Interventions

Relationship-Based Care BEHAVIORAL

Control; Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Urbino "Carlo Bo": lead
• University of Padova: collaborator

Related Publications (1)

• De Barbieri I, Sisti D, Di Falco A, Galeazzo M, Amatori S, Rocchi MBL, Perilongo G. Relationship-based care model in paediatrics: A randomized controlled trial to implement the parents' perception of the quality of nursing care. J Adv Nurs. 2020 Dec;76(12):3597-3608. doi: 10.1111/jan.14585. Epub 2020 Oct 3.

  PMID: 33009852 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Davide Sisti, Ph.D.

  University of Urbino "Carlo Bo"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 13, 2019
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share