Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates

NCT07788066 | Not Yet Recruiting DMC

• 1 other identifier: IRB No. 297
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hospital Acquired Infections

Keywords

Dextrose-Sweetened Pacifier

Outcome Measures

Primary Outcomes (1)

• Pain Intensity During Phlebotomy (Neonatal Infant Pain Scale [NIPS])

  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.

  Baseline (5 minutes immediately prior to venipuncture), intra-procedure (during the blood draw), and post-procedure (1 minute and 5 minutes after needle withdrawal).

Study Arms (3)

Yakson Touch Group

EXPERIMENTAL

Participants receive Yakson Touch during the phlebotomy procedure as a non-pharmacological pain management intervention. Yakson Touch is administered during the painful procedure, and 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 phlebotomy.

Behavioral: Yakson Touch

Dextrose-Sweetened Pacifier Group

EXPERIMENTAL

Participants receive a dextrose-sweetened pacifier during the phlebotomy procedure as a non-pharmacological pain management intervention. 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 phlebotomy.

Behavioral: Dextrose-Sweetened Pacifier

Routine Care Group

NO INTERVENTION

Participants receive routine NICU care during the phlebotomy procedure without Yakson Touch or a dextrose-sweetened pacifier. 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 phlebotomy.

Interventions

Yakson Touch BEHAVIORAL

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.

Yakson Touch Group

Dextrose-Sweetened Pacifier BEHAVIORAL

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.

Dextrose-Sweetened Pacifier Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Term neonates admitted to the NICU. Neonates undergoing clinically indicated phlebotomy. Neonates whose parent or legally authorized representative provides informed consent for participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RAK Medical and Health Sciences University: lead

Central Study Contacts

mona gamal

CONTACT

+971514146521; mona.mohamed2100@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share