Breastfeeding, ExclusiveNCT04704180
Facilitated Tucking Position's Effect on Comfort and Breastfeeding
A study testing Facilitation Tuchking Position in people with Breastfeeding, Exclusive and Position, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the effect of facilitated tucking in the early postpartum period on preterm neonate comfort and breastfeeding performance. Read more about this study
- Who is it for?
- Ages 35 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Position, Preterm Birth
- What is being tested?
- Facilitation Tuchking Position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2018to 3 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- No parental consent
- Medical intervention other than the follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breastfeeding, Exclusive, Position, Preterm Birth
- Being tested
- Facilitation Tuchking Position
- Keywords
- Facilitated tucking, breastfeeding performance, comfort, Preterm
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitation Tuchking PositionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Facilitation Tuchking Group | Experimental | The experimental group neonates received facilitated tucking under the radiant heater after birth of the NICU as well as the routine interventions. Receives: Behavioral: Facilitation Tuchking Position |
| Control Group | No intervention | The control group underwent the routine interventions of the observation unit of the NICU. The group did not receive any other intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First measurement- After admission in NICU 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.
Measured: Secont measurement- After admission in NICU 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.
Measured: In the 30th minute
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.
Measured: First breastfeeding (Within the first half an hour to an hour after birth).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start29 Nov 2018
- Primary completion29 Nov 2018
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, Principal investigator, Selcuk Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704180
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/319
- Status last verified
- Jan 2021
- First submitted
- 2 Jan 2021
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
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.
PubMed 19692803Kahraman 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.
PubMed 29248383Jensen 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.
PubMed 8176525Axelin 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.
PubMed 16410042Kucukoglu 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.
PubMed 26293573Yin 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.
PubMed 25939641Altay 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.
PubMed 36201966
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facilitated Tucking in the Early Postpartum Period on Preterm Neonatal Comfort and Breastfeeding Performance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04704180
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/319
- Conditions
- Breastfeeding, Exclusive, Position, Preterm Birth
- Keywords
- Facilitated tucking, breastfeeding performance, comfort, Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Facilitation Tuchking Group | Experimental | Behavioral: Facilitation Tuchking PositionThe experimental group neonates received facilitated tucking under the radiant heater after birth of the NICU as well as the routine interventions. |
| Control Group | No intervention | –The control group underwent the routine interventions of the observation unit of the NICU. The group did not receive any other intervention |
Who may qualify
- Ages
- 35 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- No parental consent
- Medical intervention other than the follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitation Tuchking PositionThe 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. | Behavioural | Experimental Group: Facilitation Tuchking Group |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Results publication: PubMed 19692803van 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 publication: PubMed 29248383Kahraman 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 publication: PubMed 8176525Jensen 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 publication: PubMed 16410042Axelin 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 publication: PubMed 26293573Kucukoglu 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 publication: PubMed 25939641Yin 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.
- Derived from this study: PubMed 36201966Altay 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.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
Related trials for Breastfeeding, Exclusive
Recruiting
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Growth & Development, Breastfeeding Satisfaction
Recruiting
Grandparent Breastfeeding Education and Breastfeeding Outcomes
Breastfeeding, Promotion of Exclusive Breastfeeding Through Grandparent Breastfeeding Education
Not yet recruiting
Effect of a Self-Efficacy-Based Educational Intervention on Breastfeending in Primigravid Women: A Randomized Controlled Trial
Exclusive Breastfeeding, Breastfeeding Self-Efficacy
Not yet recruiting
Impact of Chia Seeds on Human Breast Milk Composition
Obesity and Overweight, Breastfeeding, Exclusive
Not yet recruiting
Breastfeeding Education Support Tool
Breastfeeding, Exclusive, Infant Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Kucukoglu principal investigator
Selcuk Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitation Tuchking Position in people with Breastfeeding, Exclusive and Position, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Parameter Follow-up Form (time frame: First measurement- After admission in NICU 15th minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704180, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.