Relationship-based Care Model in Pediatrics

NCT ID: NCT04199429

Last Updated: 2019-12-13

Basic Information

• 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Relationship-Based Care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

University of Padova

OTHER

Sponsor Role: collaborator

University of Urbino "Carlo Bo"

OTHER

Sponsor Role: lead

Responsible Party

Davide Sisti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davide Sisti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Urbino "Carlo Bo"

References

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

UniUrb

Identifier Type: -

Identifier Source: org_study_id