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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Family-Centered Comfort | Behavioral | Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; 24 hours after admission; 12 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; 24 hours after admission; 12 hours after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordu Universitesi Egitim ve Arastirma Hastanesi | Recruiting | Ordu | Altınordu | 52200 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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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
| Standard Care (in control arm) | Other | Routine care provided to children in the control group without additional comfort interventions. |
|
| 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. | 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. | 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. | 24 hours after admission; 12 hours after intervention |
| Total Sleep Duration Measured by Wrist Actigraphy (minutes) | Total sleep time recorded using wrist actigraphy. | 24 hours after admission; 12 hours after intervention |
| Number of Night Awakenings Measured by Wrist Actigraphy (count) | Number of awakenings recorded using wrist actigraphy. | 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. | 24 hours after admission; 12 hours after intervention |