search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Assessment of physiological parameters
Assessment of Stress
Assessment of Comfort
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Labor

Eligibility Criteria

1 Hour - 2 Hours (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Serap ÖZDEMİR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Effect of facilitated tucking after preterm labor

Supine position after preterm labor

Arm Description

Implementation of facilitated tucking after preterm labor

Implementation of supine position after preterm labor

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2021
Last Updated
June 21, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
search

1. Study Identification

Unique Protocol Identification Number
NCT05430321
Brief Title
The Effect of Facilitated Tucking After Vaginal Delivery on Late Preterm Stress, Comfort and Physiological Parameters
Official Title
The Effect of Facilitated Tucking After Vaginal Delivery on Late Preterm Stress, Comfort and Physiological Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor, Preterm Labor With Preterm Delivery in Third Trimester, Preterm Spontaneous Labor With Preterm Delivery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effect of facilitated tucking after preterm labor
Arm Type
Experimental
Arm Description
Implementation of facilitated tucking after preterm labor
Arm Title
Supine position after preterm labor
Arm Type
No Intervention
Arm Description
Implementation of supine position after preterm labor
Intervention Type
Other
Intervention Name(s)
Assessment of physiological parameters
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Assessment of Stress
Intervention Description
Newborn Stress Scale (NSS) was used end of the all procedures which means 13th minute.
Intervention Type
Other
Intervention Name(s)
Assessment of Comfort
Intervention Description
Neonatal Comfort Behavior Scale (NCBS) was used end of the all procedures which means 13th minute.
Primary Outcome Measure Information:
Title
Sample characteristic
Description
the characteristics of the preterm infants and their mothers in the groups.
Time Frame
13 minutes
Title
Physiological parameter (Heart rate)-1
Description
the parameters (heart rate) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.
Time Frame
13 minutes
Title
Physiological parameter (oxygen saturation)-2
Description
the parameters (oxygen saturation) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.
Time Frame
13 minutes
Title
Physiological parameter (respiratory rate)-3
Description
It was stated that the parameters (respiratory rate) of the groups.
Time Frame
13 minutes
Title
Neonatal Stress Scale scores
Description
It was stated that the mean Neonatal Stress Scale scores between groups (min=3 max=11).
Time Frame
13 minutes
Title
Newborn Comfort Behaviour Scale scores
Description
It was determined that the mean Newborn Comfort Behaviour Scale scores between groups (min=6 max 30).
Time Frame
13 minutes
Title
Physiological parameter (body temperature)-4
Description
It was observed that the parameters (body temperature).
Time Frame
13 minutes

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feyza Bulbul, PhD
Organizational Affiliation
Pediatric Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Serap ÖZDEMİR
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
26002861
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.
Results Reference
result
PubMed Identifier
32062050
Citation
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.
Results Reference
result
PubMed Identifier
20618166
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.
Results Reference
result
PubMed Identifier
29656669
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: 10.1080/14767058.2018.1465550. Epub 2018 Apr 26.
Results Reference
result
PubMed Identifier
30144169
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 21.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs