Hospital Acquired InfectionsYakson Touch;NCT07788066
Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates
A study testing Yakson Touch and Dextrose-Sweetened Pacifier in people with Hospital Acquired Infections, run by RAK Medical and Health Sciences University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospital Acquired Infections
- What is being tested?
- Yakson Touch and Dextrose-Sweetened Pacifier
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 11 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Term neonates admitted to the NICU. Neonates undergoing clinically indicated phlebotomy. Neonates whose parent or legally authorized representative provides informed consent for participation.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hospital Acquired Infections
- Being tested
- Yakson Touch, Dextrose-Sweetened Pacifier
- Keywords
- Dextrose-Sweetened Pacifier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yakson TouchBehavioural
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.
Dextrose-Sweetened PacifierBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (5 minutes immediately prior to venipuncture), intra-procedure (during the blood draw), and post-procedure (1 minute and 5 minutes after needle withdrawal).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion12 Nov 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Acquired InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAK Medical and Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Gamal, RAK Medical and Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788066
- Sponsor's protocol ID
- IRB No. 297
- Acronym
- Yakson Touch;
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07788066
- Acronym / sponsor ID
- Yakson Touch; / IRB No. 297
- Conditions
- Hospital Acquired Infections
- Keywords
- Dextrose-Sweetened Pacifier
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- RAK Medical and Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yakson Touch Group | Experimental | Behavioral: Yakson TouchParticipants 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. |
| Dextrose-Sweetened Pacifier Group | Experimental | Behavioral: Dextrose-Sweetened PacifierParticipants 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Term neonates admitted to the NICU. Neonates undergoing clinically indicated phlebotomy. Neonates whose parent or legally authorized representative provides informed consent for participation.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yakson TouchYakson 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. | Behavioural | Yakson Touch Group |
| Dextrose-Sweetened PacifierA 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. | Behavioural | Dextrose-Sweetened Pacifier Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hospital Acquired Infections
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Drug Resistant Tuberculosis
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Yakson Touch and Dextrose-Sweetened Pacifier in people with Hospital Acquired Infections, run by RAK Medical and Health Sciences University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mona gamal (+971514146521, mona.mohamed2100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.