Infant, Newborn, DiseaseNCT05510271
Pain in Newborn Heel Blood Collection
A study testing White Noise and Yakson Touch in people with Infant, Newborn, Disease and Pain, Acute, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.Questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and… Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Disease, Pain, Acute
- What is being tested?
- White Noise and Yakson Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational week 37 and above,
- fasting time < 1 hour,
- without comorbidity and congenital anomalies,
- not receiving oxygen or mechanical respiratory support,
- no analgesic sedation before the procedure
- neonates with stable physiological findings before the procedure
Who cannot join
- newborns whose heel blood cannot be taken at once
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of White Noise and Therapeutic Touch on Pain in Newborn Heel Blood Collection
This study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.Questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and previous heel blood collection were collected with the "Information Form".The Newborn Infant Pain Scale (NIPS) was used to evaluate the pain levels of newborns.
- Conditions
- Infant, Newborn, Disease, Pain, Acute
- Being tested
- White Noise, Yakson Touch
- Medical subject headings
- Disease, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White NoiseOther
Orhan OSMAN's song "Don't Let Your Baby Cry-2" from the "Kolik" album was used.
Yakson TouchOther
In order to transfer the Ki energy to the baby, he took a deep breath and gathered the universal energy in his palms, intending the baby's well-being and healing. The researcher applied the Yakson touch by covering the abdomen and chest of the newborn with his right hand (dominant hand) while the newborn was in the supine position, and supported the baby's back and hips with his left hand.
| Study group | Role | What they receive |
|---|---|---|
| White Noise | Experimental | Not described Receives: Other: White Noise |
| Yakson touch | Experimental | Not described Receives: Other: Yakson Touch |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Newborn Infant Pain Scale (NIPS)
The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 May 2022
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseaseStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- MSc Reyhan YALÇIN, MSc Meral Güven
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510271
- Sponsor's protocol ID
- ATA.0.01.00/124
- Status last verified
- Feb 2024
- First submitted
- 18 Aug 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Noise and Therapeutic Touch on Pain in Newborn Heel Blood Collection
- ClinicalTrials.gov ID
- NCT05510271
- Acronym / sponsor ID
- ATA.0.01.00/124
- Conditions
- Infant, Newborn, Disease, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- MSc Reyhan YALÇIN, MSc Meral Güven
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 22 Aug 2022 (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.
This study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.Questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and previous heel blood collection were collected with the "Information Form".The Newborn Infant Pain Scale (NIPS) was used to evaluate the pain levels of newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White Noise | Experimental | Other: White Noise |
| Yakson touch | Experimental | Other: Yakson Touch |
| Control | No intervention | – |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- gestational week 37 and above,
- fasting time < 1 hour,
- without comorbidity and congenital anomalies,
- not receiving oxygen or mechanical respiratory support,
- no analgesic sedation before the procedure
Key exclusion criteria (1 listed)
- newborns whose heel blood cannot be taken at once
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 |
|---|---|---|
| White NoiseOrhan OSMAN's song "Don't Let Your Baby Cry-2" from the "Kolik" album was used. | Other | White Noise |
| Yakson TouchIn order to transfer the Ki energy to the baby, he took a deep breath and gathered the universal energy in his palms, intending the baby's well-being and healing. The researcher applied the Yakson touch by covering the abdomen and chest of the newborn with his right hand (dominant hand) while the newborn was in the supine position, and supported the baby's back and hips with his left hand. | Other | Yakson touch |
Primary outcome
The Newborn Infant Pain Scale (NIPS)
Time frame: 12 week
The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Noise and Yakson Touch in people with Infant, Newborn, Disease and Pain, Acute, run by Ataturk University at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Newborn Infant Pain Scale (NIPS) (time frame: 12 week). 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 6 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.