Position on Premature InfantsNCT06752005
The Effect of Positioning on Comfort, Stress Levels, and Physiological Functions in Premature Infants
A study testing Intervention Group in people with Position on Premature Infants and Nursing Care, run by Aydin Adnan Menderes University at 2 sites in Turkey (Türkiye).
Trial summary
A randomized crossover study was made to investigate the effect of different positions on the comfort, stress, and physiological functions of premature infants receiving non-invasive mechanical ventilation in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Position on Premature Infants, Nursing Care
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Jun 2019to 3 Aug 2021
- 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 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born between 28 and 36 gestational weeks, with no congenital anomalies, no intraventricular hemorrhage or periventricular leukomalacia, and no history of surgical interventions.
Who cannot join
- - Congenital anomaly,
- Has a clinical, surgical or congenital problem that makes the positions impossible,
- Surgical intervention,
- Intracranial hemorrhage and/or periventricular leukomalacia,
- Bronchopulmonary dysplasia
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aydın Adnan Menderes University
Aydin, Aydın, 09100
Turkey Aydın Adnan Menderes University, Medicine and Health Sciences Research and Applications Hospital, Neonatal Intensive Care Unit
Aydin, Turkey, 09100
About this study
Official title: The Effects of Positioning on Comfort, Stress Levels, and Physiological Functions in Premature Infants Receiving Non-Invasive Mechanical Ventilation: A Randomized Crossover Study
A randomized crossover study was made to investigate the effect of different positions on the comfort, stress, and physiological functions of premature infants receiving non-invasive mechanical ventilation in the neonatal intensive care unit (NICU).
Read the detailed description
Positioning is a crucial care practice for premature infants receiving non-invasive mechanical ventilation, as it creates a safe and confined environment similar to the uterus. In addition to creating a secure environment, positioning supports skin integrity, aids respiratory and circulatory functions , prevents musculoskeletal problems, reduces pain and stress from treatment and care interventions, promotes safe sleep, enhances comfort, and thereby accelerates the recovery process. These practices provide numerous physiological and neurodevelopmental benefits. In premature infants, improper timing and technique in positioning can lead to major risks, including cranial deformities, restricted movement in the arms and legs, postural deformities such as ankle and shoulder extension, hip abduction, skin issues like decubitus ulcers, and respiratory and circulatory problems like venous return disorders, hypoxia, and apnea episodes. In the Neonatal Intensive Care Unit (NICU), positioning management is used to reduce infants' pain or discomfort from medical interventions and environmental stimuli. Maintaining proper posture also helps them cope with stress. Stress can negatively affect neonatal brain development. For patients and premature infants on mechanical ventilation, a nest-like bed can be created using towels, blankets, or similar materials that support a flexed posture and enhance comfort. In 24-hour periods, it is important to change the position regularly, at least every three to four hours. Properly positioning the infant in a flexed posture facilitates self-regulatory movements, such as sucking, bringing hands to the mouth, and moving hands over the eyes. Ensuring the infant's comfort reduces startle responses to harmful stimuli, conserves energy, minimizes stress, and helps maintain physiological balance. Reducing the infant's stress and enhancing comfort through developmental care supports neurodevelopment. Positioning is a non-invasive practice in caring for premature infants and forms a key part of developmentally supportive care.
Nurses should adjust infants' positions according to their unique physiological conditions rather than relying on a single position, aiming to reduce sequelae associated with prolonged hospitalization and to support the infants' growth and recovery. According to researchers' observations and experience, premature infants positioned in quarter prone or stomach positions show better ventilation, better oxygenation, and fewer episodes of apnea. Due to the varying results in the literature, investigators recognize the need to validate these observations scientifically. The findings are expected to make a valuable contribution to our clinical practices and scientific knowledge in this field.In light of this information, our study aims to investigate the effects of positioning premature infants receiving non-invasive mechanical ventilation in the neonatal intensive care unit in different positions on their comfort, stress levels, and physiological functions (heart rate, SpO₂, and respiratory rate). It was tested the hypotheses that there Positioning premature infants in different positions (supine, prone, and quarter prone) during non-invasive mechanical ventilation in the Neonatal Intensive Care Unit does not affect their comfort levels, stress levels and heart rate, oxygen saturation (SpO₂), or respiratory rate.
- Conditions
- Position on Premature Infants, Nursing Care
- Being tested
- Intervention Group
- Keywords
- Mechanical ventilation, Patient comfort, Nursing care, Premature infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
One of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group supine, quarter prone, prone | Experimental | One of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress. Receives: Behavioral: Intervention Group |
| Intervention Group quarter prone, prone, supine | Experimental | One of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress. Receives: Behavioral: Intervention Group |
| Intervention Group prone, supine, quarter prone | Experimental | One of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Premature Infant Comfort after positioning at 1. minutes
assessed using the The Premature Infant Comfort Scale (PICS).. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
Measured: After positioning at 1. minutes
The Premature Infant Comfort after positioning at 60 minutes
assessed using the The Premature Infant Comfort Scale (PICS).. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
Measured: After positioning at 60 minutes
The Premature Infant Comfort after positioning at 120 minutes
assessed using the Premature Infant Comfort Scale. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
Measured: After positioning at 120 minutes
The Neonatal Stress After positioning at 1. minutes
assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
Measured: After positioning at 1. minutes
The Neonatal Stress After positioning at 60 minutes
assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
Measured: After positioning at 60 minutes
The Neonatal Stress After positioning at 120 minutes
assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
Measured: The Neonatal Stress After positioning at 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start5 Jun 2019
- Primary completion9 Jun 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Position on Premature InfantsStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe 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
- Crossover
- Model description
- Crossover Assignment Following recruitment, the infants were divided into three groups, and each group was positioned in three different postures sequentially using a crossover method by randomization (1:1 randomization)
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Güler, Aydin Adnan Menderes University
- Investigators
- Funda Güler, PhD, Study chair, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752005
- Sponsor's protocol ID
- Interventional Randomize Study
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data sets generated during and/or analyzed during the current study are available from the correponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Positioning on Comfort, Stress Levels, and Physiological Functions in Premature Infants Receiving Non-Invasive Mechanical Ventilation: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT06752005
- Acronym / sponsor ID
- Interventional Randomize Study
- Conditions
- Position on Premature Infants, Nursing Care
- Keywords
- Mechanical ventilation, Patient comfort, Nursing care, Premature infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 30 Dec 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.
A randomized crossover study was made to investigate the effect of different positions on the comfort, stress, and physiological functions of premature infants receiving non-invasive mechanical ventilation in the neonatal intensive care unit (NICU).
Detailed description
Positioning is a crucial care practice for premature infants receiving non-invasive mechanical ventilation, as it creates a safe and confined environment similar to the uterus. In addition to creating a secure environment, positioning supports skin integrity, aids respiratory and circulatory functions , prevents musculoskeletal problems, reduces pain and stress from treatment and care interventions, promotes safe sleep, enhances comfort, and thereby accelerates the recovery process. These practices provide numerous physiological and neurodevelopmental benefits. In premature infants, improper timing and technique in positioning can lead to major risks, including cranial deformities, restricted movement in the arms and legs, postural deformities such as ankle and shoulder extension, hip abduction, skin issues like decubitus ulcers, and respiratory and circulatory problems like venous return disorders, hypoxia, and apnea episodes. In the Neonatal Intensive Care Unit (NICU), positioning management is used to reduce infants' pain or discomfort from medical interventions and environmental stimuli. Maintaining proper posture also helps them cope with stress. Stress can negatively affect neonatal brain development. For patients and premature infants on mechanical ventilation, a nest-like bed can be created using towels, blankets, or similar materials that support a flexed posture and enhance comfort. In 24-hour periods, it is important to change the position regularly, at least every three to four hours. Properly positioning the infant in a flexed posture facilitates self-regulatory movements, such as sucking, bringing hands to the mouth, and moving hands over the eyes. Ensuring the infant's comfort reduces startle responses to harmful stimuli, conserves energy, minimizes stress, and helps maintain physiological balance. Reducing the infant's stress and enhancing comfort through developmental care supports neurodevelopment. Positioning is a non-invasive practice in caring for premature infants and forms a key part of developmentally supportive care.
Nurses should adjust infants' positions according to their unique physiological conditions rather than relying on a single position, aiming to reduce sequelae associated with prolonged hospitalization and to support the infants' growth and recovery. According to researchers' observations and experience, premature infants positioned in quarter prone or stomach positions show better ventilation, better oxygenation, and fewer episodes of apnea. Due to the varying results in the literature, investigators recognize the need to validate these observations scientifically. The findings are expected to make a valuable contribution to our clinical practices and scientific knowledge in this field.In light of this information, our study aims to investigate the effects of positioning premature infants receiving non-invasive mechanical ventilation in the neonatal intensive care unit in different positions on their comfort, stress levels, and physiological functions (heart rate, SpO₂, and respiratory rate). It was tested the hypotheses that there Positioning premature infants in different positions (supine, prone, and quarter prone) during non-invasive mechanical ventilation in the Neonatal Intensive Care Unit does not affect their comfort levels, stress levels and heart rate, oxygen saturation (SpO₂), or respiratory rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover Assignment Following recruitment, the infants were divided into three groups, and each group was positioned in three different postures sequentially using a crossover method by randomization (1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group supine, quarter prone, prone | Experimental | Behavioral: Intervention GroupOne of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress. |
| Intervention Group quarter prone, prone, supine | Experimental | Behavioral: Intervention GroupOne of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress. |
| Intervention Group prone, supine, quarter prone | Experimental | Behavioral: Intervention GroupOne of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- born between 28 and 36 gestational weeks, with no congenital anomalies, no intraventricular hemorrhage or periventricular leukomalacia, and no history of surgical interventions.
Key exclusion criteria (5 listed)
- - Congenital anomaly,
- Has a clinical, surgical or congenital problem that makes the positions impossible,
- Surgical intervention,
- Intracranial hemorrhage and/or periventricular leukomalacia,
- Bronchopulmonary dysplasia
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 |
|---|---|---|
| Intervention GroupOne of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress. | Behavioural | Intervention Group prone, supine, quarter prone, Intervention Group quarter prone, prone, supine, Intervention Group supine, quarter prone, prone |
Primary outcome
The Premature Infant Comfort after positioning at 1. minutes
Time frame: After positioning at 1. minutes
assessed using the The Premature Infant Comfort Scale (PICS).. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
The Premature Infant Comfort after positioning at 60 minutes
Time frame: After positioning at 60 minutes
assessed using the The Premature Infant Comfort Scale (PICS).. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
The Premature Infant Comfort after positioning at 120 minutes
Time frame: After positioning at 120 minutes
assessed using the Premature Infant Comfort Scale. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
The Neonatal Stress After positioning at 1. minutes
Time frame: After positioning at 1. minutes
assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
The Neonatal Stress After positioning at 60 minutes
Time frame: After positioning at 60 minutes
assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
The Neonatal Stress After positioning at 120 minutes
Time frame: The Neonatal Stress After positioning at 120 minutes
assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
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 28 Oct 2026.
- Individual participant dataSharing planned: Yes. the data sets generated during and/or analyzed during the current study are available from the correponding author on reasonable request
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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.
Funda Güler, PhD study chair
Aydin Adnan Menderes University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Position on Premature Infants and Nursing Care, run by Aydin Adnan Menderes University at 2 sites 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 1 inclusion and 5 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The Premature Infant Comfort after positioning at 1. minutes (time frame: After positioning at 1. minutes). The study lists 6 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 28 Oct 2026.