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

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430321
• Other study ID #: Istanbul
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Facilitated tucking (FT) is a procedure that kindly flexes the newborn by placing hands on the head and hips. There is no mentioned any risk about this implementation in the literature review. Its effects are that it improves the sleep quality of the newborn and stabilizes the physiological parameters helps to gain a sense of safety related to the position, support the motor development and protect the energy. Studies have shown that facilitated tucking is practiced many times, especially pain management; however, no study has been found examining how it affects stress and comfort of the preterm newborns first nursing care after delivery. Furthermore, vaginal delivery can be a cause of stress alone for all newborns. During these procedures, nursing practices are needed to relieve the stress and to provide comfort on the newborn. Therefore, it is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters.

Material and Method: Power analysis for the present study was based on the study by a study which performed the study with at least 32, 30 preterm in each group (with 95% confidence interval and 5% alpha (two tailed)). Herein, the present study was performed with a total of 60 preterm corresponding to 30 preterm for each experimental group (It was assumed that could be lost cases during the study).Randomization was achieved by means of the computer program (https://www.randomizer.org) indicating the total number of preterm, groups and preterm groups and the preterm divided into control and experimental groups.

Experimental group: In order to eliminate the pain and stress that they experience during routine care after vaginal delivery to late preterm. 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. Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used end of the all procedures which means 13th minute. While FT was implemented by researcher, postpartum care for newborn was performed and recorded by same nurse who is on shift. Evaluation of the scales was evaluated by the researcher and the nurse working in the hospital shift (with 5 years of neonatal experience) (Observer I-Observer II).

Control group: In this group was implemented of the hospital routine care (supine position). Physiological parameters were simultaneously recorded after the vaginal delivery. Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used end of the all procedures which means 13th minute. Evaluation of the scales was evaluated by the researcher and the nurse working in the hospital shift (with 5 years of neonatal experience) (Observer I-Observer II).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Hours

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• in addition to the exact opposite of the items identified in the inclusion criteria, also cesarean, neonatal resuscitation is needed, newborn first vaccinations practices excluded.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor
• Preterm Labor With Preterm Delivery in Third Trimester
• Preterm Spontaneous Labor With Preterm Delivery

Intervention

Other:
• Assessment of physiological parameters
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
• Assessment of Stress
Newborn Stress Scale (NSS) was used end of the all procedures which means 13th minute.
• Assessment of Comfort
Neonatal Comfort Behavior Scale (NCBS) was used end of the all procedures which means 13th minute.

Locations

Country	Name	City	State
Turkey	Serap ÖZDEMIR	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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: 1 — View Citation

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. — View Citation

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: 10.108 — View Citation

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 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample characteristic	the characteristics of the preterm infants and their mothers in the groups.	13 minutes
Primary	Physiological parameter (Heart rate)-1	the parameters (heart rate) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.	13 minutes
Primary	Physiological parameter (oxygen saturation)-2	the parameters (oxygen saturation) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.	13 minutes
Primary	Physiological parameter (respiratory rate)-3	It was stated that the parameters (respiratory rate) of the groups.	13 minutes
Primary	Neonatal Stress Scale scores	It was stated that the mean Neonatal Stress Scale scores between groups (min=3 max=11).	13 minutes
Primary	Newborn Comfort Behaviour Scale scores	It was determined that the mean Newborn Comfort Behaviour Scale scores between groups (min=6 max 30).	13 minutes
Primary	Physiological parameter (body temperature)-4	It was observed that the parameters (body temperature).	13 minutes