Effects of Yakson Method and Swaddling on Pain and Physiological Parameters

Istanbul University - Cerrahpasa (IUC)

Status: Not yet enrolling

Conditions: Pain During Heal Lancing

Treatments: Other: Nonfarmacology method

Study type: Interventional

Funder types: Other

Identifiers

NCT05518916

IstanbulUC-AHacisalihoglu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Yakson Method Group

Experimental group

Description:

* 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.

Treatment:

Other: Nonfarmacology method

Swaddling Group

Experimental group

Description:

* 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

Treatment:

Other: Nonfarmacology method

Control Group

No Intervention group

Description:

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.