Clinical trial NCT04704180: Facilitated Tucking Position's Effect on Comfort and Breastfeeding
Official title: The Effect of Facilitated Tucking in the Early Postpartum Period on Preterm Neonatal Comfort and Breastfeeding Performance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Position
Preterm Birth
Keywords: Facilitated tucking
breastfeeding performance
comfort
Preterm
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 92
Sex: ALL
Minimum age (years): 35
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, stratified sampling was employed based on Gestational age. Two strata, \[35-(35+6 days)\] and \[36-(36+6 days)\], were generated to ensure even distribution in terms of Gestational age in each group. First, ninety-two preterm neonates were stratified into two groups (A and B), which were then stratified again into two: \[35-(35+6 days)\] and \[36-(36+6 days)\].

A scheme was developed to randomize the gestational weeks of \[35-(35+6 days)\] and \[36-(36+6 days)\] into two groups (A and B), resulting in the experimental and control groups stratified by the week of gestation and blocked into paired-groups of (2:2/\[35-(35+6 days)\]:\[36-(36+6 days)\]). Permutation was also used to strike a balance between the strata. Block sets were generated for each combination of the prognostic factors (gestational age). The experimental and control groups were then randomized into the strata using a random numbers table.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigated the effect of facilitated tucking in the early postpartum period on preterm neonate comfort and breastfeeding performance.

Detailed description: Individualized Developmental Care (IDC) offered by NICUs yields positive outcomes in preterm neonates and neonates. Those positions should be comfortable and safe to promote physiological stability and optimal neuromotor development. The facilitated tucking position is the position of the baby in its mother's womb. It calms the neonate and helps it feel safe and maintain body control. It also improves sleep quality, stabilizes physiological parameters, gives a sense of security, supports motor development, and optimizes energy use. The facilitated tucking position makes it easier for preterm neonates to undergo invasive procedures (heel blood collection, aspiration etc.). However, there is no published research examining the effect of the facilitated tucking position in the early postpartum period on physiological parameters, comfort, and breastfeeding performance in preterm neonates.

Eligibility criteria: 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

Primary outcomes:
measure: Physiological Parameter Follow-up Form
timeFrame: First measurement- After admission in NICU 15th minutes
measure: Physiological Parameter Follow-up Form
timeFrame: Secont measurement- After admission in NICU 30th minutes
measure: COMFORT Behavior Scale for Neonates
timeFrame: In the 30th minute
measure: LATCH
timeFrame: First breastfeeding (Within the first half an hour to an hour after birth).
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk Universty
name: Sibel Kucukoglu
role: PRINCIPAL_INVESTIGATOR
References:
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):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
citation: Kahraman A, Basbakkal Z, Yalaz M, Sozmen 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.
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. doi: 10.1111/j.1552-6909.1994.tb01847.x.
citation: Axelin A, Salantera 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. doi: 10.1016/j.earlhumdev.2005.09.012. Epub 2006 Jan 10.
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.
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. doi: 10.1016/j.ijnurstu.2015.04.012. Epub 2015 Apr 23.
citation: Altay G, Kucukoglu S. Effects of the facilitated tucking position in early period on physiological parameters, comfort and breastfeeding performance in late preterm infants: A randomized controlled trial. Midwifery. 2022 Dec;115:103492. doi: 10.1016/j.midw.2022.103492. Epub 2022 Sep 23.