Facilitated Tucking Position's Effect on Comfort and Breastfeeding

Sponsor

Selcuk University (Other)

Overall Status

Completed

CT.gov ID

NCT04704180

Collaborator

(none)

Enrollment

Location

Arms

7.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

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

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.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 :

Nov 29, 2018

Actual Primary Completion Date :

Nov 29, 2018

Actual Study Completion Date :

Jul 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

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

Physiological Parameter Follow-up Form [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
Physiological Parameter Follow-up Form [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.
COMFORT Behavior Scale for Neonates [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.
LATCH [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

Criteria

Ages Eligible for Study:

35 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	Selcuk University	Konya		Turkey	42100

Sponsors and Collaborators

Selcuk University

Investigators

Principal Investigator: Sibel Kucukoglu, Selcuk Universty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jan 11, 2021

Last Update Posted:

Jan 11, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sibel Küçükoğlu, Assoch Prof, Selcuk University

Facilitated tucking

breastfeeding performance

comfort

Preterm

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jan 11, 2021