Facilitated Tucking Position's Effect on Comfort and Breastfeeding

January 7, 2021 updated by: Sibel Küçükoğlu, Selcuk University

The Effect of Facilitated Tucking in the Early Postpartum Period on Preterm Neonatal Comfort and Breastfeeding Performance: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42100
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First measurement- After admission in NICU 15th minutes
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.
Secont measurement- After admission in NICU 30th minutes
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.
In the 30th minute
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.
First breastfeeding (Within the first half an hour to an hour after birth).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Investigators

  • Principal Investigator: Sibel Kucukoglu, Selcuk Universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2018

Primary Completion (Actual)

November 29, 2018

Study Completion (Actual)

July 3, 2019

Study Registration Dates

First Submitted

January 2, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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