The Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection in Newborns: A Randomized Controlled Study
| Registry | NCT06350071 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 120 (Actual) |
| Sponsor | Burdur Mehmet Akif Ersoy University (Other) |
| Conditions | Pain, Acute, Newborns, Crying |
| Interventions | Kangaroo Care, Swaddling (Behavioral) |
| Dates | start 2023-06-19, primary completion 2024-12-15, completion 2025-03-14, first posted 2024-04-05, last updated 2025-07-09 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Pain, Acute All trials for Newborns All trials of Kangaroo Care All trials of Swaddling
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.
Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.
This study is a prospective, randomized and controlled trial. In this study aim, the effect of kangaroo care and swaddling methods applied during heel blood collection on the pain levels and crying times in newborns will be examined.
Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; kangaroo care group (n=40), swaddling group (n=40), and control group (n=40).
Data were collected using the Infant-family Information Form, NIPS - Neonatal Infant Pain Scale, and Crying Follow-up Form.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Kangaroo Care Group | Experimental | Behavioral: Kangaroo Care | Kangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken. |
| Swaddling Group | Experimental | Behavioral: Swaddling | Heel blood will be taken while the infant was swaddled in the maternal holding. |
| Control Group | No intervention | In this group, infants received routine heel blood collection procedure. |
Sex: All, ages: 1 Day to 4 Days, accepts healthy volunteers
Inclusion Criteria: * Parents who volunteered and gave consent to participate in the research * Full term neonates (38-42 weeks of gestation) * Underwent heel stick blood drawing for routine metabolic screening, * Aged 1 to 4 days * Passed the hearing screening * Birth weight between 2500-4400 grams * Parents who know how to read, write and speak Turkish. Exclusion Criteria: * Parents with any mental problems * Infants with any chronic disease and congenital anomalies.
| Facility | City | Country | Status |
|---|---|---|---|
| Burdur Bucak State Hospital | Burdur, Bucak | Turkey (Türkiye) |