Effects of Yakson Method and Swaddling on Pain and Physiological Parameters

Study Overview
=================
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.

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

Conditions
-----------------
Pain During Heal Lancing

Intervention / Treatment
-----------------
* Other: Nonfarmacology method


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel, three-arm randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yakson Method Group<br>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. | Other: Nonfarmacology method<br>* Yakson Method and Swaddling<br>|
| Experimental: Swaddling Group<br>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 | Other: Nonfarmacology method<br>* Yakson Method and Swaddling<br>|
| No Intervention: Control Group<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nonfarmacology, pain, heal lancing, Yakson Method