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Effects of Yakson Method and Swaddling on Pain and Physiological Parameters

Effects of Yakson Method Applied by Mother and Swaddling on Pain and Physiological Parameters During Heel Stick in Newborn

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05518916
Enrollment
48
Registered
2022-08-29
Start date
2022-10-01
Completion date
2022-12-01
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain During Heal Lancing

Keywords

nonfarmacology, pain, heal lancing, Yakson Method

Brief 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.

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.

Interventions

OTHERNonfarmacology method

Yakson Method and Swaddling

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

After the researh report is written, a third person will assign an intervention and control group to the letters.

Intervention model description

Prospective, parallel, three-arm randomized controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Infant Pain Scale (NIPS):1 yearThis 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026