Pain During Heal LancingNCT05518916
Effects of Yakson Method and Swaddling on Pain and Physiological Parameters
A study testing Nonfarmacology method in people with Pain During Heal Lancing, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Type of Study: The study was planned to be conducted in a randomized controlled experimental design. Place and Time of the Research: Institutional permission will be obtained from the Balcalı Training and Research Hospital in Adana for the collection of research data. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Pain During Heal Lancing
- What is being tested?
- Nonfarmacology method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Dec 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 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at term (38-42 weeks)
- Healthy newborn
- Absence of congenital anomaly
- No analgesic or sedative medication has been administered in the last 6 hours
- Parent's consent for inclusion in the study in accordance with the consent form
- Mother's willingness to participate in the study
- The mother can be mobilized and not have a physical disability (so that she can appyl Yakson therapy for her baby)
- Being communicative
Who cannot join
- Babies whose blood cannot be drawn on the first try
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana
About this study
Official title: Effects of Yakson Method Applied by Mother and Swaddling on Pain and Physiological Parameters During Heel Stick in Newborn
Type of Study: The study was planned to be conducted in a randomized controlled experimental design.
Place and Time of the Research: Institutional permission will be obtained from the Balcalı Training and Research Hospital in Adana for the collection of research data. Researchers commit to start data collection after obtaining institutional permission. The data collection process will take 1 year after obtaining the institutional permission.
48 newborns who are suited the inclusion criteria will be included in the study. Participants will be assigned to 3 groups according to randomization: Swaddling, Yakson Method, and Control.
Read the detailed description
Total processing time and baby's crying time are calculated by watching video recordings. In order to find the total procedure time, starting from the puncture of the baby's heel, the time until the dry cotton is placed on the baby's heel after the blood collection process is completed is calculated. The heart rate and SpO2 are noted by the investigator during the heel lancing procedure. Pain assessment of infants is done by two independent neonatal nurses, apart from the researcher, by watching video recordings. The scores given by the two observers will be evaluated by making inter-observer harmony. Before the evaluation, the nurses will be trained about the scale and its evaluation.
- Conditions
- Pain During Heal Lancing
- Being tested
- Nonfarmacology method
- Keywords
- nonfarmacology, pain, heal lancing, Yakson Method
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonfarmacology methodOther
Yakson Method and Swaddling
| Study group | Role | What they receive |
|---|---|---|
| Yakson Method Group | Experimental | * The mother is informed about the benefits of the Yakson method.
* Yakson method is taught practically to the mother. Education continues until the researcher is sure that the mother has done the method correctly. The mother starts the application 10 minutes before the heel lancing is done and continues for another 5 minutes after the heel lancing is done. During the application, the baby is recorded with the camera. Just before starting the Yakson method (initial assessment), at 10 minutes of the Yakson method (just before the heel lancing), during the heel lancing while the Yakson method is in progress, and 5 minutes after the procedure (just before the end of the tender touch), the newborn's pain and physiological parameters are evaluated. Evaluation results are recorded in the application observation form. Receives: Other: Nonfarmacology method |
| Swaddling Group | Experimental | * Parents are informed about the research and verbal consent is obtained.
* Written consent is obtained with an informed consent form.
* The Mother-Baby Information Form is filled.
* Babies are fed 1 hour before blood collection.
* And researher swaddling the baby Receives: Other: Nonfarmacology method |
| Control Group | No intervention | Parents are informed about the research and verbal consent is obtained. * Written consent is obtained with an informed consent form. * The Mother-Baby Information Form is filled. * Babies are fed 1 hour before blood collection. * Before starting the heel lancing, a pulse oximeter probe will be attached to the baby's left big toe. * Blood is taken from the right heel of the foot. * During the application, the baby is recorded with the camera. * Evaluation results are recorded in the application observation form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale (NIPS):
This scale was developed in 1993 by Lawrence et al. for premature and newborns. The scale measures the infant's response to pain behaviorally. The total score of the scale ranges from 0 to 7, and scores higher than 3 indicate the presence of pain.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain During Heal LancingStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, three-arm randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Hacisalihoglu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518916
- Sponsor's protocol ID
- IstanbulUC-AHacisalihoglu
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yakson Method Applied by Mother and Swaddling on Pain and Physiological Parameters During Heel Stick in Newborn
- ClinicalTrials.gov ID
- NCT05518916
- Acronym / sponsor ID
- IstanbulUC-AHacisalihoglu
- Conditions
- Pain During Heal Lancing
- Keywords
- nonfarmacology, pain, heal lancing, Yakson Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 29 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.
Type of Study: The study was planned to be conducted in a randomized controlled experimental design.
Place and Time of the Research: Institutional permission will be obtained from the Balcalı Training and Research Hospital in Adana for the collection of research data. Researchers commit to start data collection after obtaining institutional permission. The data collection process will take 1 year after obtaining the institutional permission.
48 newborns who are suited the inclusion criteria will be included in the study. Participants will be assigned to 3 groups according to randomization: Swaddling, Yakson Method, and Control.
Detailed description
Total processing time and baby's crying time are calculated by watching video recordings. In order to find the total procedure time, starting from the puncture of the baby's heel, the time until the dry cotton is placed on the baby's heel after the blood collection process is completed is calculated. The heart rate and SpO2 are noted by the investigator during the heel lancing procedure. Pain assessment of infants is done by two independent neonatal nurses, apart from the researcher, by watching video recordings. The scores given by the two observers will be evaluated by making inter-observer harmony. Before the evaluation, the nurses will be trained about the scale and its evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, parallel, three-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Yakson Method Group | Experimental | Other: Nonfarmacology method* The mother is informed about the benefits of the Yakson method. * Yakson method is taught practically to the mother. Education continues until the researcher is sure that the mother has done the method correctly. The mother starts the application 10 minutes before the heel lancing is done and continues for another 5 minutes after the heel lancing is done. During the application, the baby is recorded with the camera. Just before starting the Yakson method (initial assessment), at 10 minutes of the Yakson method (just before the heel lancing), during the heel lancing while the Yakson method is in progress, and 5 minutes after the procedure (just before the end of the tender touch), the newborn's pain and physiological parameters are evaluated. Evaluation results are recorded in the application observation form. |
| Swaddling Group | Experimental | Other: Nonfarmacology method* Parents are informed about the research and verbal consent is obtained. * Written consent is obtained with an informed consent form. * The Mother-Baby Information Form is filled. * Babies are fed 1 hour before blood collection. * And researher swaddling the baby |
| Control Group | No intervention | –Parents are informed about the research and verbal consent is obtained. * Written consent is obtained with an informed consent form. * The Mother-Baby Information Form is filled. * Babies are fed 1 hour before blood collection. * Before starting the heel lancing, a pulse oximeter probe will be attached to the baby's left big toe. * Blood is taken from the right heel of the foot. * During the application, the baby is recorded with the camera. * Evaluation results are recorded in the application observation form. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Born at term (38-42 weeks)
- Healthy newborn
- Absence of congenital anomaly
- No analgesic or sedative medication has been administered in the last 6 hours
- Parent's consent for inclusion in the study in accordance with the consent form
Key exclusion criteria (1 listed)
- Babies whose blood cannot be drawn on the first try
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 |
|---|---|---|
| Nonfarmacology methodYakson Method and Swaddling | Other | Swaddling Group, Yakson Method Group |
Primary outcome
Neonatal Infant Pain Scale (NIPS):
Time frame: 1 year
This scale was developed in 1993 by Lawrence et al. for premature and newborns. The scale measures the infant's response to pain behaviorally. The total score of the scale ranges from 0 to 7, and scores higher than 3 indicate the presence 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 10 Aug 2026.
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 Nonfarmacology method in people with Pain During Heal Lancing, run by Istanbul University - Cerrahpasa 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 8 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 10 Aug 2026. 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?
Neonatal Infant Pain Scale (NIPS): (time frame: 1 year). 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 10 Aug 2026.