ChildrenNCT06622330
The Effect of Position Change on Pain and Cerebral Oxygen Saturation
A study testing Positioning in people with Children, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Children
- What is being tested?
- Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 29 Aug 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients whose consent form is signed by their legal guardian
- Intubated pediatric patients receiving mechanical ventilation support
- Non-sedatized pediatric patients
- Pediatric patients who have received only paracetamol and whose duration of action has exceeded 4-6 hours
Who cannot join
- Unconscious pediatric patients
- Pediatric patients receiving pharmacologic drugs other than paracetamol
- Unstable pediatric patients
- Pediatric patients with painful procedures during the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: The Effect of Position Change on Pain and Cerebral Oxygen Saturation After Endotracheal Aspiration
This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients.
Read the detailed description
This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients. The study sample consisted of 70 pediatric patients (35 in the control group and 35 in the intervention group) who met the inclusion criteria and whose parents gave informed consent. The research data were collected using the "Child Identification Form" and the "Behavioral Pain Scale". SPSS 24 program was used to analyze the data obtained in the study. Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. Children in the control group did not receive any treatment.
- Conditions
- Children
- Being tested
- Positioning
- Keywords
- Pediatrics, position, pain, oxygen saturation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PositioningOther
Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Group given position | Experimental | Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. Receives: Other: Positioning |
| Control group | No intervention | No intervention was made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Pain Scale
Determines the pain level of children. In this scale, there are three items including facial expression, upper extremities and ventilator compliance and four variables including behavioral responses to pain in each item. These are; facial expression (relaxed, partially relaxed, fully tense, grimace), upper extremities (no movement, partially flexed, fully flexed), fingers (flexed, continuously retracted), compliance with ventilation (tolerates ventilation, coughs, but often tolerates ventilation, fights with ventilator, cannot control ventilation). Each question is given a score between 1-4. The lowest score is 3 and the highest score is 12. The higher the score, the more severe the pain.
Measured: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.
Cerebral oxygen saturation
It was measured to determine the cerebral oxygen saturation of children.
Measured: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jan 2023
- Primary completion1 Apr 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysel kokcudogan, Istanbul Medipol University Hospital
- Investigators
- Aysel Kökcü Doğan, Study director, 444 85 44Aysel Kökcü Doğan, Study director, Istanbul Medipol UniversityInstitute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622330
- Sponsor's protocol ID
- E-15916306-604.01.01-209306724
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Position Change on Pain and Cerebral Oxygen Saturation After Endotracheal Aspiration
- ClinicalTrials.gov ID
- NCT06622330
- Acronym / sponsor ID
- E-15916306-604.01.01-209306724
- Conditions
- Children
- Keywords
- Pediatrics, position, pain, oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 2 Oct 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 is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients.
Detailed description
This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients. The study sample consisted of 70 pediatric patients (35 in the control group and 35 in the intervention group) who met the inclusion criteria and whose parents gave informed consent. The research data were collected using the "Child Identification Form" and the "Behavioral Pain Scale". SPSS 24 program was used to analyze the data obtained in the study. Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. Children in the control group did not receive any treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group given position | Experimental | Other: PositioningChildren in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. |
| Control group | No intervention | –No intervention was made to the control group. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients whose consent form is signed by their legal guardian
- Intubated pediatric patients receiving mechanical ventilation support
- Non-sedatized pediatric patients
- Pediatric patients who have received only paracetamol and whose duration of action has exceeded 4-6 hours
Key exclusion criteria (4 listed)
- Unconscious pediatric patients
- Pediatric patients receiving pharmacologic drugs other than paracetamol
- Unstable pediatric patients
- Pediatric patients with painful procedures during the procedure
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 |
|---|---|---|
| PositioningChildren in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. | Other | Group given position |
Primary outcome
Behavioral Pain Scale
Time frame: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.
Determines the pain level of children. In this scale, there are three items including facial expression, upper extremities and ventilator compliance and four variables including behavioral responses to pain in each item. These are; facial expression (relaxed, partially relaxed, fully tense, grimace), upper extremities (no movement, partially flexed, fully flexed), fingers (flexed, continuously retracted), compliance with ventilation (tolerates ventilation, coughs, but often tolerates ventilation, fights with ventilator, cannot control ventilation). Each question is given a score between 1-4. The lowest score is 3 and the highest score is 12. The higher the score, the more severe the pain.
Cerebral oxygen saturation
Time frame: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.
It was measured to determine the cerebral oxygen saturation of children.
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 4 Oct 2024.
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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. This study is not recruiting at the moment.
Aysel Kökcü Doğan study director
444 85 44
Aysel Kökcü Doğan study director
Istanbul Medipol UniversityInstitute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning in people with Children, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 4 Oct 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 Turkey (Türkiye). 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?
Behavioral Pain Scale (time frame: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.). 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 4 Oct 2024.