Semi-seated Holding Position to Reduce Stress Responses in in the Neonatal Intensive Care Unit

March 7, 2024 updated by: Andi Dwi Bahagia Febriani, Hasanuddin University

Semi-seated Holding Position to Reduce Stress Responses in Spontaneous Crying Newborn in the Neonatal Intensive Care Unit

This study to compare half semi seated position and side lying position with cortisol level on the neonate's stress respon

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was a randomized control trial with inclusion criteria of moderately preterm, late preterm, and term baby. Exclusion criteria were babies experiencing respiratory distress and multiple congenital anomalies. Two treatments were carried out, the first was in a semi-seated position, the second was the control group, given the side lying position, then the levels of cortisol and salivary oxytocin were compared to see the stress response.

Study Type

Interventional

Enrollment (Actual)

45

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

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia
        • Hasanuddin University

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Modertely preterm, late preterm, aterm

Exclusion Criteria:

  • neonates with respiratory distress
  • multiple congenital anomali

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semi-seated position
Semi seated position
Other: Semi seated position
The patient is positioned 45-90 degrees
Other Names:
  • Half sitting position
Other: side lying position
Side lying position
Other Names:
  • facilitated tucking
Experimental: Side Lying position
Side lying position
Other: Semi seated position
The patient is positioned 45-90 degrees
Other Names:
  • Half sitting position
Other: side lying position
Side lying position
Other Names:
  • facilitated tucking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kortisol level
Time Frame: 20 weeks
Level of cortisol after semi seated and side lying position
20 weeks
Oxytocin level
Time Frame: 20 weeks
Level of oxytocin saliva after semi seated and side lying position
20 weeks

Collaborators and Investigators

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

Sponsor

Hasanuddin University

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)

July 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UH23030202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Other researchers can contact us via email if they want to know about our research

IPD Sharing Time Frame

2024-2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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