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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yakson Method Group | Experimental |
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| Swaddling Group | Experimental |
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| Control Group | No Intervention | Parents are informed about the research and verbal consent is obtained.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonfarmacology method | Other | Yakson Method and Swaddling |
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| 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 |
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Inclusion Criteria:
Inclusion Criteria for Newborn:
Inclusion Criteria for Mother:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aslıhan Hacısalihoğlu, Master | Contact | 03223386841 | asli.han.hem@gmail.com | |
| Birsen Mutlu, PHD | Contact | 03223386842 | bdonmez@istanbul.edu.tr |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective, parallel, three-arm randomized controlled clinical trial
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After the researh report is written, a third person will assign an intervention and control group to the letters.