Preterm Birth Clinical Trial
Official title:
The Effect of Facilitated Tucking in the Early Postpartum Period on Preterm Neonatal Comfort and Breastfeeding Performance: A Randomized Controlled Trial
Verified date | January 2021 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigated the effect of facilitated tucking in the early postpartum period on preterm neonate comfort and breastfeeding performance.
Status | Completed |
Enrollment | 92 |
Est. completion date | July 3, 2019 |
Est. primary completion date | November 29, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Weeks to 37 Weeks |
Eligibility | Inclusion Criteria: - Born at 35-37 weeks of gestation, - Appropriate weight for the week of gestation, - 1-min and 5-min Apgar score of = 8, - No oxygen therapy, - No anatomical and physiological problems, - Showing no signs of illness, - No congenital disorder, - No breastfeeding problems Exclusion Criteria: - No parental consent - Medical intervention other than the follow-up |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University | Konya |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
Axelin A, Salanterä S, Lehtonen L. 'Facilitated tucking by parents' in pain management of preterm infants-a randomized crossover trial. Early Hum Dev. 2006 Apr;82(4):241-7. Epub 2006 Jan 10. — View Citation
Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. — View Citation
Kahraman A, Basbakkal Z, Yalaz M, Sözmen EY. The effect of nesting positions on pain, stress and comfort during heel lance in premature infants. Pediatr Neonatol. 2018 Aug;59(4):352-359. doi: 10.1016/j.pedneo.2017.11.010. Epub 2017 Nov 13. — View Citation
Kucukoglu S, Kurt S, Aytekin A. The effect of the facilitated tucking position in reducing vaccination-induced pain in newborns. Ital J Pediatr. 2015 Aug 21;41:61. doi: 10.1186/s13052-015-0168-9. — View Citation
van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7) — View Citation
Yin T, Yang L, Lee TY, Li CC, Hua YM, Liaw JJ. Development of atraumatic heel-stick procedures by combined treatment with non-nutritive sucking, oral sucrose, and facilitated tucking: a randomised, controlled trial. Int J Nurs Stud. 2015 Aug;52(8):1288-99 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physiological Parameter Follow-up Form | The descriptive characteristics form was based on a literature review conducted by the researcher (Axelin, Salanterä & Lehtonen, 2006; Kucukoglu, Kurt & Aytekin, 2015; Yin, Yang, Lee, Li, Hua & Liaw, 2015). Heart rate (min), oxygen saturation (SpO2%), body temperature (°C), and respiration rate (min) was measured at admission to the NICU at 15th minutes | First measurement- After admission in NICU 15th minutes | |
Primary | Physiological Parameter Follow-up Form | Heart rate (min), oxygen saturation (SpO2%), body temperature (°C), and respiration rate (min) was measured at admission to the NICU at 30th minutes. | Secont measurement- After admission in NICU 30th minutes | |
Primary | COMFORT Behavior Scale for Neonates | The COMFORT behavior scale for neonates (COMFORTneo) is a Likert-type measure of sedation and comfort needs, and pain and distress levels in NICU neonates. Van Dijk et al. (2009) established the validity and reliability of the COMFORTneo to measure only behavior in neonates. Kahraman, Basbakkal, and Yalaz (2014) adapted the scale to Turkish.
In the 30th minute of facilitated tucking, the researcher and the observer nurse completed the COMFORTneo simultaneously but separately. The neonate was in the facilitated tucking position until delivered to its mother. The Intraclass Correlation Coefficient (ICC) was calculated to check the inter-observer agreement. The results indicated a perfect inter-observer agreement. The researcher and the observer nurse had a full view of the neonate's face and body when completing the COMFORTneo, which took them about two minutes. |
In the 30th minute | |
Primary | LATCH | The LATCH breastfeeding diagnostic form was developed by Jensen, Wallace, and Kelsay (1994) and adapted to Turkish by Yenal and Okumus (2003).
Each letter of the acronym "LATCH" denotes a criterion for breastfeeding assessment: Latch onto the breast (L), audible swallowing (A), type of nipple (T), comfort (C), hold/help (H). The items are scored on a three-point Likert-type scale. After the neonate stabilized (within the first half an hour to an hour), it was delivered to the mother for breastfeeding based on specialist consent. The researcher and the observer simultaneously and independently observed the mother breastfeeding and completed the LATCH. The first breastfeeding was performed when the neonate was awake and active. |
First breastfeeding (Within the first half an hour to an hour after birth). |
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