Facilitated Tucking Position's Effect on Comfort and Breastfeeding

NCT04704180 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/319
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breastfeeding, Exclusive; Position; Preterm Birth

Keywords

Facilitated tucking; breastfeeding performance; comfort; Preterm

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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, Başbakkal, 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

• LATCH

  The LATCH breastfeeding diagnostic form was developed by Jensen, Wallace, and Kelsay (1994) and adapted to Turkish by Yenal and Okumuş (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).

Study Arms (2)

Experimental Group: Facilitation Tuchking Group

EXPERIMENTAL

The experimental group neonates received facilitated tucking under the radiant heater after birth of the NICU as well as the routine interventions.

Behavioral: Facilitation Tuchking Position

Control Group

NO INTERVENTION

The control group underwent the routine interventions of the observation unit of the NICU. The group did not receive any other intervention

Interventions

Facilitation Tuchking Position BEHAVIORAL

The nurse placed the neonate in the facilitated tucking position by rolling up a sizeable sterile towel in a U-shape and covering it with covers available in the unit and then placed the neonate in a supine position. The physiological parameters at admission and in the 15th and 30th minutes of facilitated tucking were recorded. 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 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. After the neonate stabilized (within the first half an hour to an hour), it was delivered to its mother for breastfeeding based on specialist consent. The first breastfeeding was performed and completed the LATCH by researcher and the observer nurse.

Experimental Group: Facilitation Tuchking Group

Eligibility Criteria

• Age: 35 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born at 35-37 weeks of gestation,
• Appropriate weight for the week of gestation,
• 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

You may not qualify if:

• No parental consent
• Medical intervention other than the follow-up

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, 42100, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 19692803 RESULT

• 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.

  PMID: 29248383 RESULT

• 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.

  PMID: 8176525 RESULT

• 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.

  PMID: 16410042 RESULT

• 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.

  PMID: 26293573 RESULT

• 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.

  PMID: 25939641 RESULT

• 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.

  PMID: 36201966 DERIVED

MeSH Terms

Conditions

Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sibel Kucukoglu

  Selcuk Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoch Prof

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 11, 2021
• Study Start: November 29, 2018
• Primary Completion: November 29, 2018
• Study Completion: July 3, 2019
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)