Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 3:49 AM
Study NCT ID:
NCT07441668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comfort Intervention in PICU Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "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"}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COMFORT-B Behavioral Comfort Scale Total Score (6-30)', 'timeFrame': 'Baseline; 24 hours after admission; 12 hours after intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4)", 'timeFrame': 'Baseline; 24 hours after admission; 12 hours after intervention', 'description': "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."}, {'measure': 'Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10)', 'timeFrame': 'Baseline; 24 hours after admission; 12 hours after intervention', 'description': '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.'}, {'measure': 'Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80)', 'timeFrame': 'Baseline; 12 hours after intervention', 'description': '20-item questionnaire measuring parental situational anxiety. Higher scores indicate higher anxiety.'}, {'measure': 'Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100)', 'timeFrame': '24 hours after admission; 12 hours after intervention', 'description': '25-item parent-reported questionnaire assessing satisfaction with healthcare services. Higher scores indicate greater satisfaction.'}, {'measure': 'Total Sleep Duration Measured by Wrist Actigraphy (minutes)', 'timeFrame': '24 hours after admission; 12 hours after intervention', 'description': 'Total sleep time recorded using wrist actigraphy.'}, {'measure': 'Number of Night Awakenings Measured by Wrist Actigraphy (count)', 'timeFrame': '24 hours after admission; 12 hours after intervention', 'description': 'Number of awakenings recorded using wrist actigraphy.'}, {'measure': 'Sleep Efficiency Measured by Wrist Actigraphy (%)', 'timeFrame': '24 hours after admission; 12 hours after intervention', 'description': 'Percentage of time asleep while in bed recorded using wrist actigraphy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric intensive care', 'Child comfort', 'Kolcaba Comfort Theory', 'Anxiety', 'Fear', 'Sleep'], 'conditions': ['Pediatric Intensive Care Unit', 'Comfort', 'Anxiety in Children', 'Fear', 'Sleep']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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.\n\nChild 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child aged 5-10 years\n* Has not received intravenous sedation or anesthetic medication in the past 12 hours\n* Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours\n* Conscious and able to communicate\n* Glasgow Coma Scale score of 15\n* No pain as assessed by the Wong-Baker FACES Pain Rating Scale\n* Written informed consent obtained from parent/legal guardian\n* Child and parent able to communicate in Turkish\n* No medical contraindications to non-pharmacological, non-interactive interventions\n\nExclusion Criteria:\n\n* Mechanically ventilated or intubated\n* Hearing impairment\n* Visual impairment\n* Hand motor limitations\n* Severe or profound intellectual disability\n* Epilepsy or history of seizures\n* Severe underweight\n* Chronic respiratory disease\n* Chronic cardiovascular disease\n* Surgical implants\n* Osteoporosis\n* Diagnosis of sleep disorder\n* Use of sleep medication\n* Any physical or mental health condition that prevents communication'}, 'identificationModule': {'nctId': 'NCT07441668', 'acronym': 'CCI-PICU', 'briefTitle': 'Comfort Intervention in PICU Children', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2025/262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group - Family-Centered Comfort', 'description': "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.", 'interventionNames': ['Behavioral: Intervention Family-Centered Comfort']}, {'type': 'OTHER', 'label': 'Control Group - Standard Care', 'description': 'Children receive standard care in the PICU without the additional comfort interventions. Outcomes measured are the same as the intervention group for comparison purposes.', 'interventionNames': ['Other: Standard Care (in control arm)']}], 'interventions': [{'name': 'Intervention Family-Centered Comfort', 'type': 'BEHAVIORAL', 'description': "Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.", 'armGroupLabels': ['Intervention Group - Family-Centered Comfort']}, {'name': 'Standard Care (in control arm)', 'type': 'OTHER', 'description': 'Routine care provided to children in the control group without additional comfort interventions.', 'armGroupLabels': ['Control Group - Standard Care']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}