The Effects of Biofeedback Intervention on Negative Emotions and Sleep Quality in Children With Leukemia Receiving Invasive Procedures and Their Caregivers: A Randomized Controlled Trial.
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OBJECTIVE: Children with leukemia and their caregivers have negative experiences such as pain, fear, and sleep disturbances when receiving invasive procedures. The purpose of this study was to evaluate the effects of a biofeedback intervention on negative emotions and sleep quality for children with leukemia receiving invasive procedures and their caregivers. METHODS: A randomized controlled study involving 80 child-caregiver dyads was conducted, and dyads were randomly assigned to intervention (n = 40) and control (n = 40) groups. Both groups received health education, while the intervention group additionally received a 4-unit biofeedback intervention. Outcome measures compared at baseline (T0), post-intervention (T1), and 4-week follow-up (T2), included validated measures of pain, fear, worry, sleep quality in children, and anxiety, depression, and sleep quality in caregivers. RESULTS: At T1 and T2, the scores of children's pain and fear in the intervention group were significantly lower than those in the control group (all p < 0.05). The significant group effects on children's pain (F = 6.064, p = 0.015) and fear (F = 15.532, p < 0.001) indicated that the intervention group had significantly lower scores in pain and fear compared to the control group. At T1 and T2, caregivers in the intervention group had significantly lower anxiety scores and significantly higher sleep quality than those in the control group (all p < 0.05). The significant group effects on anxiety (F = 10.124, p = 0.002) and sleep quality (F = 5.983, p = 0.015) suggested that the intervention group had significantly lower scores in anxiety and higher sleep quality in comparison to the control group. CONCLUSIONS: The biofeedback intervention demonstrated significant efficacy in alleviating the pain, and fear experienced by children with leukemia during invasive procedures, concurrently relieving their caregivers' anxiety and improving sleep quality. This research furnishes compelling evidence substantiating the effectiveness of biofeedback interventions in alleviating negative emotions in children with leukemia undergoing invasive treatments, as well as in their caregivers. TRIAL REGISTRATION: ChiCTR2300075306.