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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Preterm Labor, Preterm Labor With Preterm Delivery in Third Trimester, Preterm Spontaneous Labor With Preterm Delivery

Intervention / Treatment
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* Other: Assessment of physiological parameters
* Other: Assessment of Stress
* Other: Assessment of Comfort


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 2 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effect of facilitated tucking after preterm labor<br>Implementation of facilitated tucking after preterm labor | Other: Assessment of physiological parameters<br>* 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<br>Other: Assessment of Stress<br>* Newborn Stress Scale (NSS) was used end of the all procedures which means 13th minute.<br>Other: Assessment of Comfort<br>* Neonatal Comfort Behavior Scale (NCBS) was used end of the all procedures which means 13th minute.<br>|
| No Intervention: Supine position after preterm labor<br>Implementation of supine position after preterm labor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |