Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates (Yakson Touch;)
August 23, 2026 updated by: Mona Gamal, RAK Medical and Health Sciences University
Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates: A Three-Arm Randomized Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mona gamal
- Phone Number: +971514146521
- Email: mona.mohamed2100@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yakson Touch Group
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.
|
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.
|
|
Experimental: Dextrose-Sweetened Pacifier Group
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.
|
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.
|
|
No Intervention: Routine Care Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity During Phlebotomy (Neonatal Infant Pain Scale [NIPS])
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.
|
Baseline (5 minutes immediately prior to venipuncture), intra-procedure (during the blood draw), and post-procedure (1 minute and 5 minutes after needle withdrawal).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
November 12, 2026
Study Completion (Estimated)
December 11, 2026
Study Registration Dates
First Submitted
July 17, 2026
First Submitted That Met QC Criteria
August 23, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 23, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB No. 297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.