Semi-seated Holding Position to Reduce Stress Responses i... | NCT06312007

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

NCT06312007

Sponsor

Hasanuddin University

Status

Completed

Last Update Posted

Aug 9, 2024Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Semi Seated Position
Side Lying Position

Interventions

Semi seated position
side lying position

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2023Actual

Primary Completion Date

Nov 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Feb 29, 2024

First Submission Date that Met QC Criteria

Mar 7, 2024

First Posted Date

Mar 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2024

Last Update Posted Date

Aug 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semi-seated position	Experimental	Semi seated position	Other: Semi seated position Other: side lying position
Side Lying position	Experimental	Side lying position	Other: Semi seated position Other: side lying position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semi seated position	Other	The patient is positioned 45-90 degrees	Semi-seated position Side Lying position

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Modertely preterm, late preterm, aterm

Exclusion Criteria:

neonates with respiratory distress
multiple congenital anomali

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

32 Weeks

Maximum Age

42 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hasanuddin University		Makassar	South Sulawesi		Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

2024-2025

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D060867	Facilitated Tucking

Ancestor Terms

ID	Term
D007224	Infant Care
D002654	Child Care
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided