Depression, AnxietyNCT04199429
Relationship-based Care Model in Pediatrics
A study testing Relationship-Based Care in people with Depression, Anxiety and Nurse-Patient Relations, run by University of Urbino "Carlo Bo".
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression, Anxiety, Nurse-Patient Relations
- What is being tested?
- Relationship-Based Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Parents of hospitalized patients for a duration of less than 4 days
About this study
Official title: Relationship-based Care Model in Pediatrics: a Randomized Controlled Trial to Implement the Parents' Perception of Quality of Nursing Care
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
- Being tested
- Relationship-Based Care
- Keywords
- Relationship-based care, Pediatric, Caregiver anxiety, Nurse job satisfaction, Nurse
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship-Based CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Relationship-Based Care |
| Control | Active comparator | Standard nursing time dedicated daily to patients and parents. Receives: Behavioral: Relationship-Based Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study startFeb 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Urbino "Carlo Bo"
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Principal investigator, Davide Sisti, University of Urbino "Carlo Bo"
- Investigators
- Davide Sisti, Ph.D., Principal investigator, University of Urbino "Carlo Bo"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199429
- Sponsor's protocol ID
- UniUrb
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33009852
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship-based Care Model in Pediatrics: a Randomized Controlled Trial to Implement the Parents' Perception of Quality of Nursing Care
- ClinicalTrials.gov ID
- NCT04199429
- Acronym / sponsor ID
- UniUrb
- Conditions
- Depression, Anxiety, Nurse-Patient Relations
- Keywords
- Relationship-based care, Pediatric, Caregiver anxiety, Nurse job satisfaction, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Urbino "Carlo Bo"University, hospital or other
- Collaborators
- University of Padova
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Relationship-Based CareEach 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. |
| Control | Active comparator | Behavioral: Relationship-Based CareStandard nursing time dedicated daily to patients and parents. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Parents of hospitalized patients for a duration of less than 4 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship-Based Care | Behavioural | Control, Experimental |
Primary outcome
Change from T0 to T1 and T2 of the Hospital Anxiety and Depression Scale (HADS) scores
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])
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.
2 secondary outcomes
Caring Behaviors Inventory (CBI)
Time frame: 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
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Derived from this study: PubMed 33009852De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Sisti, Ph.D. principal investigator
University of Urbino "Carlo Bo"
Questions about this trial
What is this clinical trial studying?
A study testing Relationship-Based Care in people with Depression, Anxiety and Nurse-Patient Relations, run by University of Urbino "Carlo Bo".
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from T0 to T1 and T2 of the Hospital Anxiety and Depression Scale (HADS) scores (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])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.