CompletedNot Applicable

Effects of Yakson Method and Swaddling on Pain and Physiological Parameters

Turkey (Türkiye)48 participantsStarted 2022-10-01

Plain-language 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. 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.

Who can participate

Age range

0 Days – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion Criteria for Newborn: * 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 Inclusion Criteria for Mother: * 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 Exclusion Criteria: * Babies whose blood cannot be drawn on the first try

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neonatal Infant Pain Scale (NIPS):

Timeframe: 1 year

Trial details

NCT IDNCT05518916

SponsorIstanbul University - Cerrahpasa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Pain During Heal Lancing trials