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Completed

NCT Number: NCT04704180

Facilitated Tucking Position's Effect on Comfort and Breastfeeding

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

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Key information

Conditions

Breastfeeding, Exclusive Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Position Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

35 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, 42100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 11, 2021
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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