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

October 9, 2024 updated by: SERAP ÖZDEMİR, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27000
        • Serap ÖZDEMİR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 2 hours (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Kilis 7 Aralik University

Investigators

  • Principal Investigator: Feyza Bulbul, PhD, Pediatric Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Istanbul

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers would like to share all manuscript other colleges if this study is published.

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

If this study is published, than will share

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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