Anxiety in Children, Comfort, Fear, Pediatric Intensive Care Unit, Sleep
Conditions
Keywords
Pediatric intensive care, Child comfort, Kolcaba Comfort Theory, Anxiety, Fear, Sleep
Brief 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. 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.
Interventions
OTHERStandard Care (in control arm)
Routine care provided to children in the control group without additional comfort interventions.
BEHAVIORALIntervention Family-Centered Comfort
Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Children aged 5-10 who meet the inclusion criteria will be randomly assigned to intervention and control groups. Parents will provide written informed consent via a consent form without being informed of group allocation. Since the intervention (storytelling using the mother's voice, dimmed lighting, and weighted blanket) is administered directly by the researcher, the researcher cannot be blinded. To minimize detection bias, outcome assessments (child comfort, anxiety, fear, sleep, parent anxiety, and satisfaction with care) will be performed by two independent, university-educated nurses working in the PICU who are unaware of the group assignments. Inter-rater reliability between the two nurses will be evaluated, and the mean of their measurements will be used for analysis. To reduce bias during data analysis, group information will be coded as A and B by an individual outside the research team. Statistical analyses will be conducted by an independent statistician blinded to group id
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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
Exclusion criteria
* Mechanically ventilated or intubated * Hearing impairment * Visual impairment * Hand motor limitations * Severe or profound intellectual disability * Epilepsy or history of seizures * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COMFORT-B Behavioral Comfort Scale Total Score (6-30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10) | Baseline; 24 hours after admission; 12 hours after intervention | 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. |
| Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80) | Baseline; 12 hours after intervention | 20-item questionnaire measuring parental situational anxiety. Higher scores indicate higher anxiety. |
| Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100) | 24 hours after admission; 12 hours after intervention | 25-item parent-reported questionnaire assessing satisfaction with healthcare services. Higher scores indicate greater satisfaction. |
| Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4) | Baseline; 24 hours after admission; 12 hours after intervention | 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. |
| Number of Night Awakenings Measured by Wrist Actigraphy (count) | 24 hours after admission; 12 hours after intervention | Number of awakenings recorded using wrist actigraphy. |
| Sleep Efficiency Measured by Wrist Actigraphy (%) | 24 hours after admission; 12 hours after intervention | Percentage of time asleep while in bed recorded using wrist actigraphy. |
| Total Sleep Duration Measured by Wrist Actigraphy (minutes) | 24 hours after admission; 12 hours after intervention | Total sleep time recorded using wrist actigraphy. |
Countries
Turkey (Türkiye)
Outcome results
None listed