The Effect of Facilitated Tucking After Vaginal Delivery on Late Preterm Stress, Comfort and Physiological Parameters

NCT05430321 | Completed DMC

• 1 other identifier: Istanbul
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: It is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters. Design: The study was designed randomized controlled study. Setting: The study was conducted spontaneous vaginal delivery of late preterm at State Hospital between January-June 2020. Participants: In order to determine the sample size of the study, power analysis was performed using the G\*Power (v3.1, 7) program, and a total of 60 preterm were sampled, facilitated tucking (n=30) and control group (n=30). Methods: In the study, Newborn Information and Registration Form, Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used. As for physiological parameters, for the temperature is used private digital thermometer, for the saturation and heart rate is used device preferred in hospital routine and lastly the respirator rate is clocked by nurses.

Conditions

Preterm Labor; Preterm Labor with Preterm Delivery in Third Trimester; Preterm Spontaneous Labor with Preterm Delivery

Outcome Measures

Primary Outcomes (7)

• Sample characteristic

  the characteristics of the preterm infants and their mothers in the groups.

  13 minutes

• Physiological parameter (Heart rate)-1

  the parameters (heart rate) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.

  13 minutes

• Physiological parameter (oxygen saturation)-2

  the parameters (oxygen saturation) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.

  13 minutes

• Physiological parameter (respiratory rate)-3

  It was stated that the parameters (respiratory rate) of the groups.

  13 minutes

• Neonatal Stress Scale scores

  It was stated that the mean Neonatal Stress Scale scores between groups (min=3 max=11).

  13 minutes

• Newborn Comfort Behaviour Scale scores

  It was determined that the mean Newborn Comfort Behaviour Scale scores between groups (min=6 max 30).

  13 minutes

• Physiological parameter (body temperature)-4

  It was observed that the parameters (body temperature).

  13 minutes

Study Arms (2)

Effect of facilitated tucking after preterm labor

EXPERIMENTAL

Implementation of facilitated tucking after preterm labor

Other: Assessment of physiological parameters; Other: Assessment of Stress; Other: Assessment of Comfort

Supine position after preterm labor

NO INTERVENTION

Implementation of supine position after preterm labor

Interventions

Assessment of physiological parameters OTHER

FT implementation begins 3 minutes before the procedures and 10 minutes continuous. After the end of the procedures further 3 minutes was given . Physiological parameters were simultaneously recorded on the registration form

Effect of facilitated tucking after preterm labor

Assessment of Stress OTHER

Newborn Stress Scale (NSS) was used end of the all procedures which means 13th minute.

Effect of facilitated tucking after preterm labor

Assessment of Comfort OTHER

Neonatal Comfort Behavior Scale (NCBS) was used end of the all procedures which means 13th minute.

Effect of facilitated tucking after preterm labor

Eligibility Criteria

• Age: 1 Hour - 2 Hours
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• spontaneous vaginal delivery,
• Apgar score 1. min \> 7
• between 35-36 (6/7) gestation weeks,
• without congenital anomaly or any syndrome,
• surgery is not needed,
• mechanical ventilation is not needed,
• accepted by parents.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Kilis 7 Aralik University: collaborator

Study Sites (1)

Serap ÖZDEMİR

Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (5)

• Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.

  PMID: 26002861 BACKGROUND

• Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.

  PMID: 32062050 BACKGROUND

• Cignacco E, Axelin A, Stoffel L, Sellam G, Anand K, Engberg S. Facilitated tucking as a non-pharmacological intervention for neonatal pain relief: is it clinically feasible? Acta Paediatr. 2010 Dec;99(12):1763-5. doi: 10.1111/j.1651-2227.2010.01941.x.

  PMID: 20618166 BACKGROUND

• Davari S, Borimnejad L, Khosravi S, Haghani H. The effect of the facilitated tucking position on pain intensity during heel stick blood sampling in premature infants: a surprising result. J Matern Fetal Neonatal Med. 2019 Oct;32(20):3427-3430. doi: 10.1080/14767058.2018.1465550. Epub 2018 Apr 26.

  PMID: 29656669 BACKGROUND

• Gautheyrou L, Durand S, Jourdes E, De Jonckheere J, Combes C, Cambonie G. Facilitated tucking during early neonatologist-performed echocardiography in very preterm neonates. Acta Paediatr. 2018 Dec;107(12):2079-2085. doi: 10.1111/apa.14555. Epub 2018 Sep 21.

  PMID: 30144169 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Feyza Bulbul, PhD

  Pediatric Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: June 24, 2022
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 15, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years
• Access Criteria: If this study is published, than will share

Locations

TU (1)