Facilitated Tucking Position's Effect on Comfort and Breastfeeding
Primary Purpose
Breastfeeding, Exclusive, Position, Preterm Birth
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Facilitation Tuchking Position
Sponsored by

About this trial
This is an interventional supportive care trial for Breastfeeding, Exclusive focused on measuring Facilitated tucking, breastfeeding performance, comfort, Preterm
Eligibility 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
Sites / Locations
- Selcuk University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group: Facilitation Tuchking Group
Control Group
Arm Description
The experimental group neonates received facilitated tucking under the radiant heater after birth of the NICU as well as the routine interventions.
The control group underwent the routine interventions of the observation unit of the NICU. The group did not receive any other intervention
Outcomes
Primary Outcome Measures
Physiological Parameter Follow-up Form
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
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04704180
Brief Title
Facilitated Tucking Position's Effect on Comfort and Breastfeeding
Official Title
The Effect of Facilitated Tucking in the Early Postpartum Period on Preterm Neonatal Comfort and Breastfeeding Performance: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigated the effect of facilitated tucking in the early postpartum period on preterm neonate comfort and breastfeeding performance.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Exclusive, Position, Preterm Birth
Keywords
Facilitated tucking, breastfeeding performance, comfort, Preterm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group: Facilitation Tuchking Group
Arm Type
Experimental
Arm Description
The experimental group neonates received facilitated tucking under the radiant heater after birth of the NICU as well as the routine interventions.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group underwent the routine interventions of the observation unit of the NICU. The group did not receive any other intervention
Intervention Type
Behavioral
Intervention Name(s)
Facilitation Tuchking Position
Intervention Description
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 Outcome Measure Information:
Title
Physiological Parameter Follow-up Form
Description
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
Time Frame
First measurement- After admission in NICU 15th minutes
Title
Physiological Parameter Follow-up Form
Description
Heart rate (min), oxygen saturation (SpO2%), body temperature (°C), and respiration rate (min) was measured at admission to the NICU at 30th minutes.
Time Frame
Secont measurement- After admission in NICU 30th minutes
Title
COMFORT Behavior Scale for Neonates
Description
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.
Time Frame
In the 30th minute
Title
LATCH
Description
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.
Time Frame
First breastfeeding (Within the first half an hour to an hour after birth).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Kucukoglu
Organizational Affiliation
Selcuk Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University
City
Konya
ZIP/Postal Code
42100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
19692803
Citation
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.
Results Reference
result
PubMed Identifier
29248383
Citation
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.
Results Reference
result
PubMed Identifier
8176525
Citation
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.
Results Reference
result
PubMed Identifier
16410042
Citation
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.
Results Reference
result
PubMed Identifier
26293573
Citation
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.
Results Reference
result
PubMed Identifier
25939641
Citation
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.
Results Reference
result
PubMed Identifier
36201966
Citation
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.
Results Reference
derived
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Facilitated Tucking Position's Effect on Comfort and Breastfeeding
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