Pediatric Intensive Care UnitCCI-PICUNCT07441668
Comfort Intervention in PICU Children
A study testing Intervention Family-Centered Comfort in people with Pediatric Intensive Care Unit and Comfort, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Intensive Care Unit, Comfort, Anxiety in Children
- What is being tested?
- Intervention Family-Centered Comfort
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged 5-10 years
- Has not received intravenous sedation or anesthetic medication in the past 12 hours
- Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours
- Conscious and able to communicate
- Glasgow Coma Scale score of 15
- No pain as assessed by the Wong-Baker FACES Pain Rating Scale
Show all 9Show fewer
- Written informed consent obtained from parent/legal guardian
- Child and parent able to communicate in Turkish
- No medical contraindications to non-pharmacological, non-interactive interventions
Who cannot join
- Mechanically ventilated or intubated
- Hearing impairment
- Visual impairment
- Hand motor limitations
- Severe or profound intellectual disability
- Epilepsy or history of seizures
Show all 14Show fewer
- Severe underweight
- Chronic respiratory disease
- Chronic cardiovascular disease
- Surgical implants
- Osteoporosis
- Diagnosis of sleep disorder
- Use of sleep medication
- Any physical or mental health condition that prevents communication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ordu Universitesi Egitim ve Arastirma Hastanesi
Ordu, Altınordu, 52200
Mine Nur Temucin, PhD, 90452 226 52 00, minenurtemucin@odu.edu.tr
About this study
Official title: The Effect of a Kolcaba Comfort Theory-Based Child Comfort Intervention on Comfort, Anxiety, Fear, and Sleep in the Pediatric Intensive Care Unit: A Randomized Controlled Trial
This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.
Read the detailed description
This randomized controlled trial will be conducted in a PICU to evaluate the effectiveness of a family-centered comfort intervention based on Kolcaba's Comfort Theory. Eligible children and their parents will be enrolled after consent and randomly assigned to an intervention group or a control group.
The control group will receive routine nursing care. The intervention group will receive routine care plus a multidimensional comfort intervention including maternal voice exposure, environmental light regulation, and a weighted blanket.
Child outcomes will include comfort, anxiety, fear, and sleep parameters. Parent outcomes will include state anxiety and satisfaction with care. Assessments will be performed at baseline, 24 hours after admission, and 12 hours after completion of the intervention. The primary objective is to determine whether the intervention improves child comfort and related outcomes, and whether it positively affects parental anxiety and satisfaction compared with routine care.
- Conditions
- Pediatric Intensive Care Unit, Comfort, Anxiety in Children, Fear, Sleep
- Being tested
- Intervention Family-Centered Comfort, Standard Care (in control arm)
- Keywords
- Pediatric intensive care, Child comfort, Kolcaba Comfort Theory, Anxiety, Fear, Sleep
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Family-Centered ComfortBehavioural
Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.
Standard Care (in control arm)Other
Routine care provided to children in the control group without additional comfort interventions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Family-Centered Comfort | Experimental | Children receive a multifaceted, family-centered comfort intervention including storytelling using the mother's voice, dimmed lighting, and weighted blanket. Outcomes measured include child comfort, anxiety, fear, sleep, and parent anxiety and satisfaction. Receives: Behavioral: Intervention Family-Centered Comfort |
| Control Group - Standard Care | Other | Children receive standard care in the PICU without the additional comfort interventions. Outcomes measured are the same as the intervention group for comparison purposes. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMFORT-B Behavioral Comfort Scale Total Score (6-30)
Behavioral comfort assessed using the COMFORT-B Behavioral Comfort Scale. Six items scored from 1 to 5. Total score ranges from 6 to 30. Higher scores indicate lower comfort.
Measured: Baseline; 24 hours after admission; 12 hours after intervention
Secondary outcomes (7)
Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4)
Fear intensity assessed using the validated Children's Fear Scale (CFS), a five-face visual self-report scale. Scores range from 0 (no fear) to 4 (extreme fear). Higher scores indicate greater fear.
Measured: Baseline; 24 hours after admission; 12 hours after intervention
Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10)
Situational anxiety assessed using the Child Anxiety Meter (CAM), a thermometer-style visual analog scale ranging from 0 (no anxiety) to 10 (extreme anxiety). Higher scores indicate greater anxiety.
Measured: Baseline; 24 hours after admission; 12 hours after intervention
Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80)
20-item questionnaire measuring parental situational anxiety. Higher scores indicate higher anxiety.
Measured: Baseline; 12 hours after intervention
Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100)
25-item parent-reported questionnaire assessing satisfaction with healthcare services. Higher scores indicate greater satisfaction.
Measured: 24 hours after admission; 12 hours after intervention
Total Sleep Duration Measured by Wrist Actigraphy (minutes)
Total sleep time recorded using wrist actigraphy.
Measured: 24 hours after admission; 12 hours after intervention
Number of Night Awakenings Measured by Wrist Actigraphy (count)
Number of awakenings recorded using wrist actigraphy.
Measured: 24 hours after admission; 12 hours after intervention
Sleep Efficiency Measured by Wrist Actigraphy (%)
Percentage of time asleep while in bed recorded using wrist actigraphy.
Measured: 24 hours after admission; 12 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start20 Feb 2026
- Primary completion15 May 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Intensive Care UnitStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the intervention group, receiving a multifaceted, family-centered comfort intervention, or the control group, receiving standard care. Outcomes are compared between groups to assess the effectiveness of the intervention on child comfort, anxiety, fear, and sleep, as well as parent anxiety and satisfaction.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441668
- Sponsor's protocol ID
- 2025/262
- Acronym
- CCI-PICU
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Kolcaba Comfort Theory-Based Child Comfort Intervention on Comfort, Anxiety, Fear, and Sleep in the Pediatric Intensive Care Unit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07441668
- Acronym / sponsor ID
- CCI-PICU / 2025/262
- Conditions
- Pediatric Intensive Care Unit, Comfort, Anxiety in Children, Fear, Sleep
- Keywords
- Pediatric intensive care, Child comfort, Kolcaba Comfort Theory, Anxiety, Fear, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Mar 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 randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.
Detailed description
This randomized controlled trial will be conducted in a PICU to evaluate the effectiveness of a family-centered comfort intervention based on Kolcaba's Comfort Theory. Eligible children and their parents will be enrolled after consent and randomly assigned to an intervention group or a control group.
The control group will receive routine nursing care. The intervention group will receive routine care plus a multidimensional comfort intervention including maternal voice exposure, environmental light regulation, and a weighted blanket.
Child outcomes will include comfort, anxiety, fear, and sleep parameters. Parent outcomes will include state anxiety and satisfaction with care. Assessments will be performed at baseline, 24 hours after admission, and 12 hours after completion of the intervention. The primary objective is to determine whether the intervention improves child comfort and related outcomes, and whether it positively affects parental anxiety and satisfaction compared with routine care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the intervention group, receiving a multifaceted, family-centered comfort intervention, or the control group, receiving standard care. Outcomes are compared between groups to assess the effectiveness of the intervention on child comfort, anxiety, fear, and sleep, as well as parent anxiety and satisfaction.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Family-Centered Comfort | Experimental | Behavioral: Intervention Family-Centered ComfortChildren receive a multifaceted, family-centered comfort intervention including storytelling using the mother's voice, dimmed lighting, and weighted blanket. Outcomes measured include child comfort, anxiety, fear, sleep, and parent anxiety and satisfaction. |
| Control Group - Standard Care | Other | Other: Standard Care (in control arm)Children receive standard care in the PICU without the additional comfort interventions. Outcomes measured are the same as the intervention group for comparison purposes. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Child aged 5-10 years
- Has not received intravenous sedation or anesthetic medication in the past 12 hours
- Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours
- Conscious and able to communicate
- Glasgow Coma Scale score of 15
Key exclusion criteria (14 listed)
- Mechanically ventilated or intubated
- Hearing impairment
- Visual impairment
- Hand motor limitations
- Severe or profound intellectual disability
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 |
|---|---|---|
| Intervention Family-Centered ComfortStorytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group. | Behavioural | Intervention Group - Family-Centered Comfort |
| Standard Care (in control arm)Routine care provided to children in the control group without additional comfort interventions. | Other | Control Group - Standard Care |
Primary outcome
COMFORT-B Behavioral Comfort Scale Total Score (6-30)
Time frame: Baseline; 24 hours after admission; 12 hours after intervention
Behavioral comfort assessed using the COMFORT-B Behavioral Comfort Scale. Six items scored from 1 to 5. Total score ranges from 6 to 30. Higher scores indicate lower comfort.
7 secondary outcomes
Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4)
Time frame: Baseline; 24 hours after admission; 12 hours after intervention
Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10)
Time frame: Baseline; 24 hours after admission; 12 hours after intervention
Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80)
Time frame: Baseline; 12 hours after intervention
Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100)
Time frame: 24 hours after admission; 12 hours after intervention
Total Sleep Duration Measured by Wrist Actigraphy (minutes)
Time frame: 24 hours after admission; 12 hours after intervention
Number of Night Awakenings Measured by Wrist Actigraphy (count)
Time frame: 24 hours after admission; 12 hours after intervention
Sleep Efficiency Measured by Wrist Actigraphy (%)
Time frame: 24 hours after admission; 12 hours after intervention
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 12 May 2026.
Related trials for Pediatric Intensive Care Unit
Not yet recruitingObservational study
PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
Not yet recruitingObservational study
pSOFA Score in Predicting Mortality in Pediatric Intensive Care
Critical Illness, Multiple Organ Dysfunction Syndrome
Recruiting
Probiotic Role in Prevention of Ventilator Associated Pneumonia in Critically- Ill Children Admitted at Pediatric Intensive Care Unit
Probiotic, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Delirium in the Intensive Care Unit
RecruitingObservational study
A Korean Point Prevalence Study of Acute Rehabilitation for Kids in the PICU (PARK-PICU)
Pediatric Intensive Care Units
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.
Ordu Universitesi Egitim ve Arastirma Hastanesi
Ordu, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Family-Centered Comfort in people with Pediatric Intensive Care Unit and Comfort, run by Ankara Yildirim Beyazıt 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 12 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMFORT-B Behavioral Comfort Scale Total Score (6-30) (time frame: Baseline; 24 hours after admission; 12 hours after intervention). 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 12 May 2026.