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Completed

NCT Number: NCT05518916

Effects of Yakson Method and Swaddling on Pain and Physiological Parameters

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.

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nonfarmacology method

Other

Yakson Method and Swaddling

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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