Family Centered CareNCT06668285
The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU
An observational study of Family Centered Care and Comfort, run by Izmir Katip Celebi University.
Trial summary
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study. The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Family Centered Care, Comfort, Vital Sign Evaluation
- What is being tested?
- parental presence
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: 0-3 years
Who may be able to join
- Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
- Parent's volunteering to participate in the study Exclusion Criteria
- 1. Any intervention by the child's parent that may affect the dependent variables (watching cartoons, listening to music, etc.)
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.
The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.
Read the detailed description
There is a growing concern about psychological sequelae in children after hospitalization in the PICU. Despite the prevalence of adverse outcomes such as post-traumatic stress disorder, anxiety and behavioral problems in children after NICU admission, interventions to promote children's comfort have been limited. Children are physically and emotionally vulnerable and exposed to highly harmful environmental stimuli in the PICU. In a study by Johnston et al. in which mothers attempted to touch and talk to children during invasive procedures to reduce children's pain, children recovered faster and mothers experienced reduced anxiety, helplessness and an increased sense of purpose in caring for their children. Melnyk et al. examined the effect of a maternal coping intervention and found less anxiety in mothers and children. Despite these findings, the role of the parent when a child is hospitalized in the PICU is poorly defined. Parents describe the role change in the PICU as a tremendous stressor and report feeling helpless, anxious and fearful at the bedside. They suggest that comforting approaches that mimic home routines may alleviate these feelings and benefit their child.The study is planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.
The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study
- Conditions
- Family Centered Care, Comfort, Vital Sign Evaluation, Parent
- Being tested
- parental presence
- Keywords
- family centered care, parents presence, comfort, vital signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parental presenceBehavioural
parental presence in PICU
What is being measured
The primary outcome is the main question the study is designed to answer.
comfort scale point
before, during and after the 1st and 5th minute of the visit
Measured: Baseline, and first minute of the visit and first/fifth minute after the visit
Secondary outcomes (4)
heart rate
heart rate will be measured by Braun YK-81CEU
Measured: Baseline, and first minute of the visit and first/fifth minute after the visit
saturation
saturation will be measured by Braun YK-81CEU
Measured: Baseline, and first minute of the visit and first/fifth minute after the visit
respiratory rate
respiratory rate will be measured by Braun YK-81CEU
Measured: Baseline, and first minute of the visit and first/fifth minute after the visit
blood pressure
blood pressure will be measured by Nimo HS-20C Aneroid
Measured: Baseline, and first minute of the visit and first/fifth minute after the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Apr 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Centered 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
- Investigators
- Esra Ardahan Akgül, PhD, Study chair, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668285
- Sponsor's protocol ID
- 101
- Status last verified
- Apr 2025
- First submitted
- 30 Oct 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU
- ClinicalTrials.gov ID
- NCT06668285
- Acronym / sponsor ID
- 101
- Conditions
- Family Centered Care, Comfort, Vital Sign Evaluation, Parent
- Keywords
- family centered care, parents presence, comfort, vital signs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Oct 2024 (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.
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.
The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.
Detailed description
There is a growing concern about psychological sequelae in children after hospitalization in the PICU. Despite the prevalence of adverse outcomes such as post-traumatic stress disorder, anxiety and behavioral problems in children after NICU admission, interventions to promote children's comfort have been limited. Children are physically and emotionally vulnerable and exposed to highly harmful environmental stimuli in the PICU. In a study by Johnston et al. in which mothers attempted to touch and talk to children during invasive procedures to reduce children's pain, children recovered faster and mothers experienced reduced anxiety, helplessness and an increased sense of purpose in caring for their children. Melnyk et al. examined the effect of a maternal coping intervention and found less anxiety in mothers and children. Despite these findings, the role of the parent when a child is hospitalized in the PICU is poorly defined. Parents describe the role change in the PICU as a tremendous stressor and report feeling helpless, anxious and fearful at the bedside. They suggest that comforting approaches that mimic home routines may alleviate these feelings and benefit their child.The study is planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.
The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 0-3 years
Key inclusion criteria (3 listed)
- Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
- Parent's volunteering to participate in the study Exclusion Criteria
- 1. Any intervention by the child's parent that may affect the dependent variables (watching cartoons, listening to music, etc.)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| parental presenceparental presence in PICU | Behavioural | – |
Primary outcome
comfort scale point
Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit
before, during and after the 1st and 5th minute of the visit
4 secondary outcomes
heart rate
Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit
saturation
Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit
respiratory rate
Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit
blood pressure
Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Family Centered Care
Recruiting
COMUNICAR: Community-Led Family-Centered Communication for Cancer Survivorship Care
Childhood Cancer
Enrolling by invitation
BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
Traumatic Brain Injury
Enrolling by invitation
Attitudes, Experience and Adaptation to Family Presence in the ICU
ICU Staff Attitudes Toward Family Presence, ICU Staff Experience of Family Presence
Not yet recruiting
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Premature Birth, Infant, Premature
Enrolling by invitation
EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET
Prevention of Childhood Obesity, Community Health Education
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.
Esra Ardahan Akgül, PhD study chair
İzmir Katip Çelebi University
Questions about this trial
What is this clinical trial studying?
An observational study of Family Centered Care and Comfort, run by Izmir Katip Celebi University.
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 0 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: opening soon, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Ardahan Akgül, PhD (+00905544318386, esraardahan90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comfort scale point (time frame: Baseline, and first minute of the visit and first/fifth minute after the visit). 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 9 Apr 2025.