Facilitated Tucking Position's Effect on Comfort and Breastfeeding

• ClinicalTrials.gov Identifier: NCT04704180
• Recruitment Status: Completed
• First Posted: January 11, 2021
• Last Update Posted: January 11, 2021
• Sponsor: Selcuk University
• Information provided by (Responsible Party): Sibel Küçükoğlu, Selcuk University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Breastfeeding, Exclusive; Position; Preterm Birth	Behavioral: Facilitation Tuchking Position	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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.

• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Facilitated Tucking in the Early Postpartum Period on Preterm Neonatal Comfort and Breastfeeding Performance: A Randomized Controlled Trial
• Actual Study Start Date: November 29, 2018
• Actual Primary Completion Date: November 29, 2018
• Actual Study Completion Date: July 3, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Group: Facilitation Tuchking Group; 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; 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.
No Intervention: Control Group; The control group underwent the routine interventions of the observation unit of the NICU. The group did not receive any other intervention

Outcome Measures

Primary Outcome Measures :

1. Physiological Parameter Follow-up Form [ Time Frame: First measurement- After admission in NICU 15th minutes ]
   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
2. Physiological Parameter Follow-up Form [ Time Frame: Secont measurement- After admission in NICU 30th minutes ]
   Heart rate (min), oxygen saturation (SpO2%), body temperature (°C), and respiration rate (min) was measured at admission to the NICU at 30th minutes.
3. COMFORT Behavior Scale for Neonates [ Time Frame: In the 30th minute ]

   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.

4. LATCH [ Time Frame: First breastfeeding (Within the first half an hour to an hour after birth). ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 35 Weeks to 37 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Turkey

Selcuk University

Konya, Turkey, 42100

Sponsors and Collaborators

Selcuk University

Investigators

• Principal Investigator: Sibel Kucukoglu; Selcuk Universty

More Information

Publications of Results:

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.

Kahraman A, Başbakkal 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.

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.

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.

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.

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.

• Responsible Party: Sibel Küçükoğlu, Assoch Prof, Selcuk University
• ClinicalTrials.gov Identifier: NCT04704180
• Other Study ID Numbers: B.30.2.ATA.0.01.00/319
• First Posted: January 11, 2021
• Last Update Posted: January 11, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: It will be shared after the article is published.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sibel Küçükoğlu, Selcuk University:

Facilitated tucking; breastfeeding performance; comfort; Preterm

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications