Pediatric Intensive CareNCT07585903
The Effect of Family-Centered Care Practices In Pediatric Intensive Care Unit
A study testing Family-Centered Care Protocol in people with Pediatric Intensive Care, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of family-centered care practices on parental satisfaction and anxiety levels in a pediatric intensive care unit (PICU). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pediatric Intensive Care
- What is being tested?
- Family-Centered Care Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2025to 20 Jan 2026
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mother of a child admitted to the PICU of Kastamonu Training and Research Hospital
- Child aged 0-18 years
- PICU stay expected to be at least 48 hours
- Able to communicate verbally in Turkish
- Willing to provide written informed consent
Who cannot join
- Mother with a known diagnosed psychiatric disorder
- Child admitted for end-of-life or palliative care only
- Mother unable to be physically present in the hospital
- Father or non-maternal primary caregiver
- Participation in another clinical study simultaneously -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kastamonu Training and Research Hospital
Kastamonu, 37000
About this study
Official title: The Effect of Family-Centered Care Practices In Pediatric Intensive Care Unit On Parental Satisfaction And Anxiety Levels
This study aims to evaluate the effects of family-centered care practices on parental satisfaction and anxiety levels in a pediatric intensive care unit (PICU).
Read the detailed description
Admission of a child to the pediatric intensive care unit (PICU) is one of the most stressful experiences a family can face. Parents of critically ill children frequently experience high levels of anxiety, helplessness, and loss of parental role. Family-centered care (FCC) is a philosophy of care that recognizes the family as an essential component of the child's care team, emphasizing partnership, participation, and information sharing between healthcare providers and families.Although FCC has been increasingly advocated in pediatric critical care settings, its systematic implementation and measurable impact on parental outcomes remain insufficiently studied in the Turkish PICU context.This study will be conducted in the Pediatric Intensive Care Unit (PICU) of Kastamonu Training and Research Hospital, Kastamonu, Turkey. Kastamonu Training and Research Hospital is a tertiary-level public hospital serving the Kastamonu province and surrounding regions.his is a quasi-experimental study with an intervention group and a control group. A total of 80 parents will be enrolled: 40 in the intervention group and 40 in the control group. Participants will be recruited consecutively. Parents in the control group will receive standard care, while parents in the intervention group will receive a structured family-centered care protocol in addition to standard care.Parents assigned to the intervention group will participate in a structured FCC protocol delivered by trained PICU nurses, which includes:
Active parental participation in care: Parents will be encouraged and supported to participate in their child's daily care activities such as comfort care, positioning, and feeding where clinically appropriate.
Structured informational meetings: Parents will receive regular, planned verbal and written information from the nursing staff and medical team regarding their child's condition and care plan.
Family-centered care education booklet: Parents will be provided with an informational booklet developed specifically for the PICU environment at Kastamonu Training and Research Hospital, covering what to expect during the ICU stay, how to communicate with the care team, and how to actively participate in care.he control group will receive routine standard care as currently practiced in the unit, without the structured FCC protocol or the educational booklet.
Data Collection
Questionnaires will be administered at two time points:
T1 - Baseline: Within 24 hours of PICU admission T2 - Discharge: Within 24 hours before PICU discharge
Outcome Measures
The following validated instruments will be used:
State-Trait Anxiety Inventory (STAI): Measures parental anxiety at admission and discharge.
EMPATHIC-30 Scale: Measures parental satisfaction with PICU care at discharge. Family-Centered Care Scale: Measures the degree to which parents feel included, respected, and supported in the care process - at admission and discharge.
Expected Outcomes It is hypothesized that parents in the FCC intervention group (n=40) will demonstrate significantly lower anxiety scores and significantly higher satisfaction and family-centered care perception scores compared to the control group (n=40) at discharge.
- Conditions
- Pediatric Intensive Care
- Being tested
- Family-Centered Care Protocol
- Keywords
- Family-Centered Care, Parental satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Centered Care ProtocolBehavioural
A structured family-centered care (FCC) protocol was implemented by trained PICU nurses. The protocol consisted of three components: (1) active parental participation in daily care activities such as comfort care, positioning, and feeding where clinically appropriate; (2) structured informational meetings providing regular verbal and written information about the child's condition and care plan; and (3) provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. The intervention was applied throughout the PICU stay. Outcome measures were collected at admission (baseline) and within 24 hours before discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group Control Group | Experimental | Kol 1 - Intervention Group:
Parents in this group received a structured family-centered care (FCC) protocol in addition to standard care. The protocol included active parental participation in daily care activities, structured informational meetings with the nursing and medical team, and provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. Questionnaires were administered at PICU admission and within 24 hours before discharge.
Kol 2 - Control Group:
Parents in this group received routine standard care as currently practiced in the PICU of Kastamonu Training and Research Hospital, without any structured family-centered care protocol or educational booklet. Questionnaires were administered at PICU admission and within 24 hours before discharge. Receives: Behavioral: Family-Centered Care Protocol |
| arm1 Intervention Group arm 2 Control Group | Experimental | Kol 1 - Intervention Group:
Parents in this group received a structured family-centered care (FCC) protocol in addition to standard care. The protocol included active parental participation in daily care activities, structured informational meetings with the nursing and medical team, and provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. Questionnaires were administered at PICU admission and within 24 hours before discharge.
Kol 2 - Control Group:
Parents in this group received routine standard care as currently practiced in the PICU of Kastamonu Training and Research Hospital, without any structured family-centered care protocol or educational booklet. Questionnaires were administered at PICU admission and within 24 hours before discharge. Receives: Behavioral: Family-Centered Care Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Anxiety Level Parental Satisfaction Family-Centered Care Perception
Parental Anxiety Level Parental anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The scale consists of two subscales: state anxiety (STAI-I) and trait anxiety (STAI-II), each containing 20 items scored between 20-80. Higher scores indicate higher anxiety levels.
Parental Satisfaction Parental satisfaction will be measured using the EMPATHIC-30 Scale, a validated instrument designed to measure parent satisfaction in pediatric intensive care units. The scale consists of 30 items rated on a 5-point Likert scale. Higher scores indicate higher satisfaction levels.
Measured: At PICU admission (baseline) and within 24 hours before discharge Within 24 hours before PICU discharge At PICU admission (baseline) and within 24 hours before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start19 Apr 2025
- Primary completion10 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Intensive CareStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Koç Sarıkaya, Zonguldak Bulent Ecevit University
- Investigators
- KÜBRA KOÇ SARIKAYA, MSN, Principal investigator, kuubra.koc@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585903
- Sponsor's protocol ID
- 696
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family-Centered Care Practices In Pediatric Intensive Care Unit On Parental Satisfaction And Anxiety Levels
- ClinicalTrials.gov ID
- NCT07585903
- Acronym / sponsor ID
- 696
- Conditions
- Pediatric Intensive Care
- Keywords
- Family-Centered Care, Parental satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 19 Apr 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 14 May 2026 (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.
This study aims to evaluate the effects of family-centered care practices on parental satisfaction and anxiety levels in a pediatric intensive care unit (PICU).
Detailed description
Admission of a child to the pediatric intensive care unit (PICU) is one of the most stressful experiences a family can face. Parents of critically ill children frequently experience high levels of anxiety, helplessness, and loss of parental role. Family-centered care (FCC) is a philosophy of care that recognizes the family as an essential component of the child's care team, emphasizing partnership, participation, and information sharing between healthcare providers and families.Although FCC has been increasingly advocated in pediatric critical care settings, its systematic implementation and measurable impact on parental outcomes remain insufficiently studied in the Turkish PICU context.This study will be conducted in the Pediatric Intensive Care Unit (PICU) of Kastamonu Training and Research Hospital, Kastamonu, Turkey. Kastamonu Training and Research Hospital is a tertiary-level public hospital serving the Kastamonu province and surrounding regions.his is a quasi-experimental study with an intervention group and a control group. A total of 80 parents will be enrolled: 40 in the intervention group and 40 in the control group. Participants will be recruited consecutively. Parents in the control group will receive standard care, while parents in the intervention group will receive a structured family-centered care protocol in addition to standard care.Parents assigned to the intervention group will participate in a structured FCC protocol delivered by trained PICU nurses, which includes:
Active parental participation in care: Parents will be encouraged and supported to participate in their child's daily care activities such as comfort care, positioning, and feeding where clinically appropriate.
Structured informational meetings: Parents will receive regular, planned verbal and written information from the nursing staff and medical team regarding their child's condition and care plan.
Family-centered care education booklet: Parents will be provided with an informational booklet developed specifically for the PICU environment at Kastamonu Training and Research Hospital, covering what to expect during the ICU stay, how to communicate with the care team, and how to actively participate in care.he control group will receive routine standard care as currently practiced in the unit, without the structured FCC protocol or the educational booklet.
Data Collection
Questionnaires will be administered at two time points:
T1 - Baseline: Within 24 hours of PICU admission T2 - Discharge: Within 24 hours before PICU discharge
Outcome Measures
The following validated instruments will be used:
State-Trait Anxiety Inventory (STAI): Measures parental anxiety at admission and discharge.
EMPATHIC-30 Scale: Measures parental satisfaction with PICU care at discharge. Family-Centered Care Scale: Measures the degree to which parents feel included, respected, and supported in the care process - at admission and discharge.
Expected Outcomes It is hypothesized that parents in the FCC intervention group (n=40) will demonstrate significantly lower anxiety scores and significantly higher satisfaction and family-centered care perception scores compared to the control group (n=40) at discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group Control Group | Experimental | Behavioral: Family-Centered Care ProtocolKol 1 - Intervention Group: Parents in this group received a structured family-centered care (FCC) protocol in addition to standard care. The protocol included active parental participation in daily care activities, structured informational meetings with the nursing and medical team, and provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. Questionnaires were administered at PICU admission and within 24 hours before discharge. Kol 2 - Control Group: Parents in this group received routine standard care as currently practiced in the PICU of Kastamonu Training and Research Hospital, without any structured family-centered care protocol or educational booklet. Questionnaires were administered at PICU admission and within 24 hours before discharge. |
| arm1 Intervention Group arm 2 Control Group | Experimental | Behavioral: Family-Centered Care ProtocolKol 1 - Intervention Group: Parents in this group received a structured family-centered care (FCC) protocol in addition to standard care. The protocol included active parental participation in daily care activities, structured informational meetings with the nursing and medical team, and provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. Questionnaires were administered at PICU admission and within 24 hours before discharge. Kol 2 - Control Group: Parents in this group received routine standard care as currently practiced in the PICU of Kastamonu Training and Research Hospital, without any structured family-centered care protocol or educational booklet. Questionnaires were administered at PICU admission and within 24 hours before discharge. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Mother of a child admitted to the PICU of Kastamonu Training and Research Hospital
- Child aged 0-18 years
- PICU stay expected to be at least 48 hours
- Able to communicate verbally in Turkish
- Willing to provide written informed consent
Key exclusion criteria (5 listed)
- Mother with a known diagnosed psychiatric disorder
- Child admitted for end-of-life or palliative care only
- Mother unable to be physically present in the hospital
- Father or non-maternal primary caregiver
- Participation in another clinical study simultaneously -
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 |
|---|---|---|
| Family-Centered Care ProtocolA structured family-centered care (FCC) protocol was implemented by trained PICU nurses. The protocol consisted of three components: (1) active parental participation in daily care activities such as comfort care, positioning, and feeding where clinically appropriate; (2) structured informational meetings providing regular verbal and written information about the child's condition and care plan; and (3) provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. The intervention was applied throughout the PICU stay. Outcome measures were collected at admission (baseline) and within 24 hours before discharge. | Behavioural | Intervention Group Control Group, arm1 Intervention Group arm 2 Control Group |
Primary outcome
Parental Anxiety Level Parental Satisfaction Family-Centered Care Perception
Time frame: At PICU admission (baseline) and within 24 hours before discharge Within 24 hours before PICU discharge At PICU admission (baseline) and within 24 hours before discharge
Parental Anxiety Level Parental anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The scale consists of two subscales: state anxiety (STAI-I) and trait anxiety (STAI-II), each containing 20 items scored between 20-80. Higher scores indicate higher anxiety levels. Parental Satisfaction Parental satisfaction will be measured using the EMPATHIC-30 Scale, a validated instrument designed to measure parent satisfaction in pediatric intensive care units. The scale consists of 30 items rated on a 5-point Likert scale. Higher scores indicate higher satisfaction levels.
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 14 May 2026.
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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.
KÜBRA KOÇ SARIKAYA, MSN principal investigator
kuubra.koc@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Centered Care Protocol in people with Pediatric Intensive Care, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Parental Anxiety Level Parental Satisfaction Family-Centered Care Perception (time frame: At PICU admission (baseline) and within 24 hours before discharge Within 24 hours before PICU discharge At PICU admission (baseline) and within 24 hours before discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.