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Relationship-based Care Model in Pediatrics

NCT ID: NCT04199429

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression, Anxiety Nurse-Patient Relations

Keywords

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Relationship-based care Pediatric Caregiver anxiety Nurse job satisfaction Nurse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Relationship-Based Care

Intervention Type BEHAVIORAL

Control

Standard nursing time dedicated daily to patients and parents.

Group Type ACTIVE_COMPARATOR

Relationship-Based Care

Intervention Type BEHAVIORAL

Interventions

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Relationship-Based Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role collaborator

University of Urbino "Carlo Bo"

OTHER

Sponsor Role lead

Responsible Party

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Davide Sisti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davide Sisti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Urbino "Carlo Bo"

References

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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.

Reference Type DERIVED
PMID: 33009852 (View on PubMed)

Other Identifiers

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UniUrb

Identifier Type: -

Identifier Source: org_study_id