StressNCT06136130
The Effect of Positioning With Material and Hand-Face Maneuver
A study testing Tortoise Positioning Material Group in people with Stress and Position, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The study was administered in a randomized controlled experimental design to evaluate the effects of material positioning and hand-face maneuver on physiological parameters and stress symptoms in preterm newborns with gestational weeks 28 to 32. Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- What is being tested?
- Tortoise Positioning Material Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Jul 2020
- 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 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm newborn between 28-32 weeks of gestation (very early preterm)
- Not connected to mechanical ventilator
- Parent's consent with informed consent form
Who cannot join
- Presence of congenital anomalies, a known infection, neuromuscular problems and genetic anomalies in a preterm newborn
- Have undergone any surgical intervention
- Painful procedure (invasive procedure, etc.) performed in the last hour
- Taking analgesics in the last six hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Positioning With Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
The study was administered in a randomized controlled experimental design to evaluate the effects of material positioning and hand-face maneuver on physiological parameters and stress symptoms in preterm newborns with gestational weeks 28 to 32. The sample of the study consisted of 60 preterm infants who met the selection criteria in newborn intensive care unit between September 2018 and July 2020.The newborns in the control group (n=30) were given a "nesting with a rolled up blanket" position, as in the routine of the ward. The Experimental Group1 (n=30) was given positions using a "positioner" and the same newborns (Experimental2) was given positions using "positioner and hand-face maneuver" on the second day of the study.
Read the detailed description
The universe of the study consisted of preterm newborns patients who met the selection criteria in newborn intensive care unit.The research was planned as a randomized controlled experimental study. In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomizer.org/) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the baby. The dependent variables of the study are physiological parameters, newborn position assesment tool score and newborn stress scale score In the research, "Information and follow-up form" prepared by the researcher in line with the literature was used as data collection tools. Newborn Position Assesment Tool and Newborn Stress Scale were also used
- Being tested
- Tortoise Positioning Material Group
- Keywords
- preterm, position, stress, physiological parameters
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tortoise Positioning Material GroupDevice
Also called Control Group
Preterm infants were placed in the nest with positioning material and placed in lateral and prone positions The positioning material and hand-face maneuver were applied together to the preterm infants in the Positioning Material Group 2, and they were given lateral and prone positions in this way
| Study group | Role | What they receive |
|---|---|---|
| Positioning Material | Experimental | Preterm infants in Intervention group were placed in the nest with positioning material and placed in lateral and prone positions
The positioning material and hand-face maneuver were applied together to the preterm infants in the intervention group, and they were given lateral and prone positions in this way in the second day Receives: Device: Tortoise Positioning Material Group |
| Standard Care | No intervention | Standard care was used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Position Assesment Tool
The Infant Position AssessmentTool (IPAT) is a six-item(shoulders, hands, hips, knees,ankles, feet, head, neck) tool with cumulative scores ranging from 0 to 12. A scale score of 12 indicates that the position is given very well, and a score of 0 indicates that the position is very bad.
Measured: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Newborn Stress Scale
Scale items were collected in 8 subgroups. These subgroups consist of a total of 24 items in 3-point Likert type, including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture.A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.
Measured: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Pulse rate assesment
Pulse rate/min
Measured: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Respiratory rate assesment
respiratory rate/min,
Measured: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Oxygen saturation assesment
Oxygen saturation %
Measured: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- The Effect of Positioning with Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isıl AR, Kirsehir Ahi Evran Universitesi
- Investigators
- Serap Balcı, Assoc. Prof., Study director, İstanbul University CerrahpaşaIsil AR, PhD, Study chair, İstanbul University Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136130
- Sponsor's protocol ID
- IAR
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ar I, Balci S. The effect of the use of positioning materials and hand-face maneuvers on physiologic parameters and stress symptoms in preterm newborns. Ital J Pediatr. 2025 Jul 21;51(1):239. doi: 10.1186/s13052-025-02070-z.
PubMed 40691617
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positioning With Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
- ClinicalTrials.gov ID
- NCT06136130
- Acronym / sponsor ID
- IAR
- Keywords
- preterm, position, stress, physiological parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 Nov 2023 (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 study was administered in a randomized controlled experimental design to evaluate the effects of material positioning and hand-face maneuver on physiological parameters and stress symptoms in preterm newborns with gestational weeks 28 to 32. The sample of the study consisted of 60 preterm infants who met the selection criteria in newborn intensive care unit between September 2018 and July 2020.The newborns in the control group (n=30) were given a "nesting with a rolled up blanket" position, as in the routine of the ward. The Experimental Group1 (n=30) was given positions using a "positioner" and the same newborns (Experimental2) was given positions using "positioner and hand-face maneuver" on the second day of the study.
Detailed description
The universe of the study consisted of preterm newborns patients who met the selection criteria in newborn intensive care unit.The research was planned as a randomized controlled experimental study. In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomizer.org/) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the baby. The dependent variables of the study are physiological parameters, newborn position assesment tool score and newborn stress scale score In the research, "Information and follow-up form" prepared by the researcher in line with the literature was used as data collection tools. Newborn Position Assesment Tool and Newborn Stress Scale were also used
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Effect of Positioning with Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
| Arm | Type | Receives |
|---|---|---|
| Positioning Material | Experimental | Device: Tortoise Positioning Material GroupPreterm infants in Intervention group were placed in the nest with positioning material and placed in lateral and prone positions The positioning material and hand-face maneuver were applied together to the preterm infants in the intervention group, and they were given lateral and prone positions in this way in the second day |
| Standard Care | No intervention | –Standard care was used |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm newborn between 28-32 weeks of gestation (very early preterm)
- Not connected to mechanical ventilator
- Parent's consent with informed consent form
Key exclusion criteria (4 listed)
- Presence of congenital anomalies, a known infection, neuromuscular problems and genetic anomalies in a preterm newborn
- Have undergone any surgical intervention
- Painful procedure (invasive procedure, etc.) performed in the last hour
- Taking analgesics in the last six hours
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 |
|---|---|---|
| Tortoise Positioning Material GroupAlso: Control GroupPreterm infants were placed in the nest with positioning material and placed in lateral and prone positions The positioning material and hand-face maneuver were applied together to the preterm infants in the Positioning Material Group 2, and they were given lateral and prone positions in this way | Device | Positioning Material |
Primary outcome
Newborn Position Assesment Tool
Time frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
The Infant Position AssessmentTool (IPAT) is a six-item(shoulders, hands, hips, knees,ankles, feet, head, neck) tool with cumulative scores ranging from 0 to 12. A scale score of 12 indicates that the position is given very well, and a score of 0 indicates that the position is very bad.
Newborn Stress Scale
Time frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Scale items were collected in 8 subgroups. These subgroups consist of a total of 24 items in 3-point Likert type, including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture.A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.
Pulse rate assesment
Time frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Pulse rate/min
Respiratory rate assesment
Time frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
respiratory rate/min,
Oxygen saturation assesment
Time frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Oxygen saturation %
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 18 Nov 2023.
- Derived from this study: PubMed 40691617Ar I, Balci S. The effect of the use of positioning materials and hand-face maneuvers on physiologic parameters and stress symptoms in preterm newborns. Ital J Pediatr. 2025 Jul 21;51(1):239. doi: 10.1186/s13052-025-02070-z.
- 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. This study is not recruiting at the moment.
Serap Balcı, Assoc. Prof. study director
İstanbul University Cerrahpaşa
Isil AR, PhD study chair
İstanbul University Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tortoise Positioning Material Group in people with Stress and Position, run by Kirsehir Ahi Evran Universitesi 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 3 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 18 Nov 2023. 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?
Newborn Position Assesment Tool (time frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136130, which also lists 1 linked publication.
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 18 Nov 2023.