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Relationship-based Care Model in Pediatrics

Primary Purpose

Depression, Anxiety, Nurse-Patient Relations

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Relationship-Based Care
Sponsored by
University of Urbino "Carlo Bo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Anxiety focused on measuring Relationship-based care, Pediatric, Caregiver anxiety, Nurse job satisfaction, Nurse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    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.

    Standard nursing time dedicated daily to patients and parents.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    December 2, 2019
    Last Updated
    December 12, 2019
    Sponsor
    University of Urbino "Carlo Bo"
    Collaborators
    University of Padova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04199429
    Brief Title
    Relationship-based Care Model in Pediatrics
    Official Title
    Relationship-based Care Model in Pediatrics: a Randomized Controlled Trial to Implement the Parents' Perception of Quality of Nursing Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Urbino "Carlo Bo"
    Collaborators
    University of Padova

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety, Nurse-Patient Relations
    Keywords
    Relationship-based care, Pediatric, Caregiver anxiety, Nurse job satisfaction, Nurse

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Standard nursing time dedicated daily to patients and parents.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relationship-Based Care
    Primary Outcome Measure Information:
    Title
    Change from T0 to T1 and T2 of the Hospital Anxiety and Depression Scale (HADS) scores
    Description
    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 Outcome Measure Information:
    Title
    Caring Behaviors Inventory (CBI)
    Description
    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])
    Title
    Change of the job satisfaction of the nurses
    Description
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Davide Sisti, Ph.D.
    Organizational Affiliation
    University of Urbino "Carlo Bo"
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33009852
    Citation
    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.
    Results Reference
    derived

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    Relationship-based Care Model in Pediatrics

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