Comfort Intervention in PICU Children

N/ANot Yet RecruitingNCT07441668

Ankara Yildirim Beyazıt University86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline; 24 hours after admission; 12 hours after intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 hours after admission; 12 hours after intervention

Total Sleep Duration Measured by Wrist Actigraphy (minutes)

Total sleep time recorded using wrist actigraphy.

Time frame: 24 hours after admission; 12 hours after intervention

Number of Night Awakenings Measured by Wrist Actigraphy (count)

Number of awakenings recorded using wrist actigraphy.

Time frame: 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.

Time frame: 24 hours after admission; 12 hours after intervention

Comfort Intervention in PICU Children

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes