NCT Number: NCT07788066
To compare the effects of Yakson Touch, the Dextrose-Sweetened Pacifier, and routine care on physiological responses, pain intensity, and behavioral outcomes among term neonates undergoing phlebotomy.
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Interventional
Not applicable
To compare the effects of Yakson Touch, the Dextrose-Sweetened Pacifier, and routine care on physiological responses, pain intensity, and behavioral outcomes among term neonates undergoing phlebotomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Term neonates admitted to the NICU. Neonates undergoing clinically indicated phlebotomy. Neonates whose parent or legally authorized representative provides informed consent for participation.
Exclusion criteria
Neonates with conditions that may significantly affect pain assessment or physiological responses during phlebotomy.
Neonates receiving analgesic or sedative medications that could influence pain or behavioral responses.
Neonates with contraindications to the study interventions. Neonates whose parent or legally authorized representative does not provide consent.
Yakson Touch is a non-pharmacological tactile intervention administered to term neonates during phlebotomy to reduce procedural pain and behavioral distress. The intervention is provided during the phlebotomy procedure, with physiological parameters, pain intensity using the Premature Infant Pain Profile (PIPP), and behavioral responses using the Anderson Behavioral State Scale (ABSS) assessed before, during, and after the procedure.
A dextrose-sweetened pacifier is provided to term neonates during phlebotomy as a non-pharmacological intervention for procedural pain management. Physiological parameters, pain intensity using the Premature Infant Pain Profile (PIPP), and behavioral responses using the Anderson Behavioral State Scale (ABSS) are assessed before, during, and after the phlebotomy procedure.
Time frame: Baseline (5 minutes immediately prior to venipuncture), intra-procedure (during the blood draw), and post-procedure (1 minute and 5 minutes after needle withdrawal).
Pain intensity will be assessed using the Neonatal Infant Pain Scale (NIPS), a behavioral and physiological pain assessment tool with a total score ranging from 0 to 7, with higher scores indicating greater pain. The mean change from baseline will be compared among the Yakson Touch, Dextrose-Sweetened Pacifier, and Routine Care groups.
Contact information is provided by the study sponsor or research team.
RAK Medical and Health Sciences University
Other
Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates: A Three-Arm Randomized Controlled Trial
Acronym: Yakson Touch;
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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