Assessing the effectiveness of touch intervention for pain control during examination for retinopathy of prematurity

INTERVENTION: The research team comprised three research neonatologists, a child health care expert, and three assistants with extensive research and clinical experience. After consent is obtained from parents, infants in the neonatal intensive care unit at Children’s Hospital of Nanjing Medical University who met the ROP screening criteria are randomly assigned to experimental and control groups using computer‐generated randomization codes. Clinicians, parents, and researchers were blinded to the randomization. Participants in both groups undergo a range of painful procedures during their ROP Screen in the NICU. The preterm infants in the experimental group continuously receive touch intervention during ROP screening, while those in the control group are screened according to the routine procedure. The touch intervention protocol (Gentle Human Touch) is implemented from the beginning of each procedure until 10 minutes after the procedure. The neonatologist gently places her left hand on the infant’s head with her fingertips resting immediately above the eyebrow line and her palm touching the crown. Her right hand is placed such that the right thumb was on the infant’s right shoulder (midline position) and the rest of the hand and fingers are on the infant’s arm, above the elbow. The degree of pain is assessed using the Premature Infant Pain Profile (PIPP) score. A double‐channel near‐infrared spectroscopy device is used to monitor regional cerebral oxygen saturation (rScO2), while oxygen saturation (SaO2) and heart rate (HR) are measured using pulse oximetry. The PIPP score is the primary outcome, while heart rate (HR), SaO2, and rScO2 are secondary outcomes. CONDITION: Retinopathy of prematurity ; Eye Diseases ; Retinopathy of prematurity PRIMARY OUTCOME: The degree of pain during the examination quantified using the Premature Infant Pain Profile (PIPP). The PIPP assessment items include the gestational age, increased HR, decreased blood oxygen saturation (SaO2), a state of arousal, and the proportion of painful expressions throughout the examination (frowning, blinking, and wrinkling the nose and sulcus). There are a total of seven items, each of which is scored on a scale of 0–3. The total PIPP score is calculated as the sum of the scores for all seven items, and the maximum score is 21 points. A higher score indicates greater pain severity. The video camera is positioned for a closeup of the face. The signals were fed directly to a VCR during the painful procedure. SECONDARY OUTCOME: Heart rate (HR), SaO2, and rScO2: an EGOS‐600A NIRS meter (EnginMed, Suzhou, China) is used to collect data for the regional cerebral oxygen saturation (rScO2) before and during screening. Before screening, the NIRS probe is placed at the center of the forehead. The recorder traces a 2‐min curve in the quiet state, and the stable value displayed after the curve represented the oxygen saturation of the basal brain tissue, which is then compared with the tissue oxygen saturation recorded at the time of pain during ROP screening. At the same time, a pulse oximeter (Comen Medical Instruments, Shenzhen, China) is used to measure SaO2 and HR. For calculation of the PIPP score, the infant’s facial expressions and pulse oximetry findings are recorded throughout the procedure. INCLUSION CRITERIA: 1. Premature birth with a gestational age of =34 weeks or a birth weight of =2000 g 2. No prior history of fundus screening 3. Screening at 4 to 6 weeks of age after birth or a corrected gestational age of 31 to 32 weeks