Facilitated Tucking Position's Effect on Comfort and Breastfeeding

NCT ID: NCT04704180

Last Updated: 2021-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2019-07-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Breastfeeding, Exclusive Position Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Facilitation Tuchking Position

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Sibel Küçükoğlu

Assoch Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sibel Kucukoglu

Role: PRINCIPAL_INVESTIGATOR

Selcuk Universty

Locations

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Selcuk University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 19692803 (View on PubMed)

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.

Reference Type RESULT
PMID: 29248383 (View on PubMed)

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.

Reference Type RESULT
PMID: 8176525 (View on PubMed)

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.

Reference Type RESULT
PMID: 16410042 (View on PubMed)

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.

Reference Type RESULT
PMID: 26293573 (View on PubMed)

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.

Reference Type RESULT
PMID: 25939641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36201966 (View on PubMed)

Other Identifiers

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B.30.2.ATA.0.01.00/319

Identifier Type: -

Identifier Source: org_study_id

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