Semi Seated PositionNCT06312007
Semi-seated Holding Position to Reduce Stress Responses in in the Neonatal Intensive Care Unit
A study testing Semi seated position and side lying position in people with Semi Seated Position and Side Lying Position, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This study to compare half semi seated position and side lying position with cortisol level on the neonate's stress respon Read more about this study
- Who is it for?
- Ages 32 to 42 weeks
- Conditions the study is for
- Semi Seated Position, Side Lying Position
- What is being tested?
- Semi seated position and side lying position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Jul 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Modertely preterm, late preterm, aterm
Who cannot join
- neonates with respiratory distress
- multiple congenital anomali
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Semi Seated Position, Side Lying Position
- Being tested
- Semi seated position, side lying position
- Keywords
- semi seated position, cortisol saliva, oxytocin saliva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi seated positionOther
Also called Half sitting position
The patient is positioned 45-90 degrees
side lying positionOther
Also called facilitated tucking
Side lying position
| Study group | Role | What they receive |
|---|---|---|
| Semi-seated position | Experimental | Semi seated position Receives: Other: Semi seated position; Other: side lying position |
| Side Lying position | Experimental | Side lying position Receives: Other: Semi seated position; Other: side lying position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kortisol level
Level of cortisol after semi seated and side lying position
Measured: 20 weeks
Oxytocin level
Level of oxytocin saliva after semi seated and side lying position
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start17 Jul 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Semi Seated PositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention semi seated position Control side lying position
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andi Dwi Bahagia Febriani, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312007
- Sponsor's protocol ID
- UH23030202
- Status last verified
- Aug 2024
- First submitted
- 29 Feb 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers can contact us via email if they want to know about our research
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-seated Holding Position to Reduce Stress Responses in Spontaneous Crying Newborn in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06312007
- Acronym / sponsor ID
- UH23030202
- Conditions
- Semi Seated Position, Side Lying Position
- Keywords
- semi seated position, cortisol saliva, oxytocin saliva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention semi seated position Control side lying position
| Arm | Type | Receives |
|---|---|---|
| Semi-seated position | Experimental | Other: Semi seated position, Other: side lying positionSemi seated position |
| Side Lying position | Experimental | Other: Semi seated position, Other: side lying positionSide lying position |
Who may qualify
- Ages
- 32 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Modertely preterm, late preterm, aterm
Key exclusion criteria (2 listed)
- neonates with respiratory distress
- multiple congenital anomali
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi seated positionAlso: Half sitting positionThe patient is positioned 45-90 degrees | Other | Semi-seated position, Side Lying position |
| side lying positionAlso: facilitated tuckingSide lying position | Other | Semi-seated position, Side Lying position |
Primary outcome
Kortisol level
Time frame: 20 weeks
Level of cortisol after semi seated and side lying position
Oxytocin level
Time frame: 20 weeks
Level of oxytocin saliva after semi seated and side lying position
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. Other researchers can contact us via email if they want to know about our research
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi seated position and side lying position in people with Semi Seated Position and Side Lying Position, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kortisol level (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.