Mechanical VentilationSCiPNCT07568418
Skin Conductance in Ventilated Preterms
A study testing Skin Conductance Measurement in people with Mechanical Ventilation and Pain, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The goal of this observational study is to learn more about the pain and stress experienced by newborn infants receiving mechanical ventilation (breathing through a machine). The main questions it aims to answer are: Do different ventilator settings (modi) cause different degrees of pain and stress? Can skin… Read more about this study
- Who is it for?
- Ages 22 weeks and older
- Conditions the study is for
- Mechanical Ventilation, Pain, Skin to Skin Care
- What is being tested?
- Skin Conductance Measurement
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 8 Aug 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Need for mechanical ventilation
Who cannot join
- Other distracting painful conditions
- Facial malformation or neuromuscular disease, not allowing regular visual pain assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Children's Hospital
Uppsala, Uppland, 75185
Johanna T Walan, PhD student, +46704184255, johanna.walan@uu.se
Richard Sindelar, Affiliated professor, richard.sindelar@uu.se
About this study
Official title: Pain Assessment Using Skin Conductance Measurement During Different Types of Invasive Ventilation in Newborn Infants
The goal of this observational study is to learn more about the pain and stress experienced by newborn infants receiving mechanical ventilation (breathing through a machine).
The main questions it aims to answer are:
- Do different ventilator settings (modi) cause different degrees of pain and stress?
- Can skin conductance measurement be used to evaluate the pain and stress caused by mechanical ventilation in newborns?
- Can skin-to-skin care alleviate the stress caused by mechanical ventilation?
Participants will be monitored according to clinical protocol with the addition of electrodes placed on the infant's foot, measuring changes in skin conductance.
- Conditions
- Mechanical Ventilation, Pain, Skin to Skin Care, Kangaroo Mother Care
- Being tested
- Skin Conductance Measurement
- Keywords
- Skin Conductance Measurement, Pain, Newborn
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Conductance MeasurementDevice
Objectifying stress by measuring changes in skin conductance using electrodes placed on the infants' feet.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skin conductance
Changes in skin conductance measured in micro Siemens
Measured: From the time on one ventilator setting to another, on average about two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start8 Aug 2025
- Primary completion30 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Tidehag Walan, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568418
- Sponsor's protocol ID
- Dnr 2023-03900-01
- Acronym
- SCiP
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Assessment Using Skin Conductance Measurement During Different Types of Invasive Ventilation in Newborn Infants
- ClinicalTrials.gov ID
- NCT07568418
- Acronym / sponsor ID
- SCiP / Dnr 2023-03900-01
- Conditions
- Mechanical Ventilation, Pain, Skin to Skin Care, Kangaroo Mother Care
- Keywords
- Skin Conductance Measurement, Pain, Newborn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 May 2026 (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.
The goal of this observational study is to learn more about the pain and stress experienced by newborn infants receiving mechanical ventilation (breathing through a machine).
The main questions it aims to answer are:
- Do different ventilator settings (modi) cause different degrees of pain and stress?
- Can skin conductance measurement be used to evaluate the pain and stress caused by mechanical ventilation in newborns?
- Can skin-to-skin care alleviate the stress caused by mechanical ventilation?
Participants will be monitored according to clinical protocol with the addition of electrodes placed on the infant's foot, measuring changes in skin conductance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
Who may qualify
- Ages
- 22 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Need for mechanical ventilation
Key exclusion criteria (2 listed)
- Other distracting painful conditions
- Facial malformation or neuromuscular disease, not allowing regular visual pain assessment
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 |
|---|---|---|
| Skin Conductance MeasurementObjectifying stress by measuring changes in skin conductance using electrodes placed on the infants' feet. | Device | – |
Primary outcome
Changes in skin conductance
Time frame: From the time on one ventilator setting to another, on average about two weeks
Changes in skin conductance measured in micro Siemens
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Conductance Measurement in people with Mechanical Ventilation and Pain, run by Uppsala University Hospital at 1 site in Sweden.
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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna T Walan, Student Researcher (+46704184255, johanna.walan@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in skin conductance (time frame: From the time on one ventilator setting to another, on average about two weeks). 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 5 May 2026.