Hospital Acquired Infections
Conditions
Keywords
Dextrose-Sweetened Pacifier
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALYakson Touch
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.
BEHAVIORALDextrose-Sweetened Pacifier
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.
Sponsors
RAK Medical and Health Sciences University
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity During Phlebotomy (Neonatal Infant Pain Scale [NIPS]) | 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. |
Contacts
CONTACTmona gamal
Outcome results
None listed