Premature InfantNCT06959290
Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants
A study testing Multiple nonpharmacological methods and Routine Treatment in people with Premature Infant and Retinopaty of Prematurity, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP). Read more about this study
- Who is it for?
- Ages 26 to 32 weeks
- Conditions the study is for
- Premature Infant, Retinopaty of Prematurity, Pain Management
- What is being tested?
- Multiple nonpharmacological methods and Routine Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Jun 2025
- 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 26 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postmenstrual gestational age ≤32 weeks and/or birth weight ≤1500 g,
- Stable, awake, in supine position and breathing spontaneously without oxygen support,
- Vital signs were within normal limits before the examination,
- Premature infants undergoing ROP examination for the first time.
Who cannot join
- Preterms who have been administered non-steroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital and diazepam within 24 hours before the ROP examination,
- Preterms with severe respiratory diseases, receiving respiratory support (continuous positive airway pressure or mechanical ventilation),
- Preterms with critical conditions such as central nervous system infections and sepsis,
- Preterms with other organic diseases such as severe cardiovascular disease, pulmonary insufficiency,
- Preterms with congenital malformations.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, Istanbul, 34862
About this study
Official title: Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants: A Randomised Controlled Crossover Trial
This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).
Read the detailed description
Retinopathy of prematurity (ROP) examination is performed using a binocular indirect ophthalmoscope. ROP examination causes pain and discomfort in the preterm infant in many ways, including the application of eye drops, the placement of the speculum in the eye, the pressure applied to the pupils and the brightness of the ophthalmoscope. Studies in the literature have also reported that newborns experience pain and discomfort during ROP examination. In relation to the ROP pain experienced by the preterm infant, various physiological changes such as increased heart rate or decreased oxygen saturation are experienced during or after the examination. Accordingly, ROP examination is important; however, controlling the pain that occurs during the examination is also very important in terms of the patient's emotional experience and comfort. In the literature, many studies have been conducted to reduce pain during ROP examination. Although pharmacological treatment methods are an effective technique to reduce pain, it is recommended that nonpharmacological methods should be used especially in infants and children because of the side effects of drugs (such as apnoea, bradycardia, respiratory depression, hypotension) and the method to be used should be easy, fast and does not require preparation. The Turkish Neonatology Society and the Turkish Ophthalmology Society also recommend that ROP examination is a very painful procedure, that pharmacological methods alone are not sufficient to reduce pain, and that nonpharmacological methods such as pacifier, breast milk and oral sucrose should be used during the examination. In addition, although there is no gold standard for pain relief during ROP examination, previous studies suggest that clinicians should use more than one method together to reduce pain and provide relief in premature infants. In this study, a combination of oral 25% dextrose, non-nutritive sucking and swaddling will be used for multiple nonpharmacological applications
- Conditions
- Premature Infant, Retinopaty of Prematurity, Pain Management
- Being tested
- Multiple nonpharmacological methods, Routine Treatment
- Keywords
- Premature Infant, Retinopaty of prematurity examination, Pain management
- Medical subject headings
- Premature Birth, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple nonpharmacological methodsProcedure or surgery
The preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. The nurse will then give the baby 25% dextrose solution orally (0.5ml for those <32 weeks gestation, 1ml for those >32 weeks gestation). The nurse then places a pacifier soaked in 25% dextrose solution in the preterm infant's mouth. After these three non-pharmacological methods, the doctor will perform the ROP examination.
Routine TreatmentOther
The preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. After these three non-pharmacological methods, the doctor will perform the ROP examination.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Retinopathy of prematurity examination will be performed according to clinical routine practice. Receives: Other: Routine Treatment |
| Intervention Group | Active comparator | Multiple nonpharmacological methods will be applied for pain management during retinopathy of prematurity examination. Receives: Procedure: Multiple nonpharmacological methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R)
The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of <7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.
Measured: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure
Secondary outcomes (2)
Oxygen saturation
Premature infants will be connected to a pulse oximeter monitor; oxygen saturation will be monitored before, during and after the procedure.
Measured: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure
Heart rate
Premature infants will be connected to a pulse oximeter monitor; heart rate will be monitored before, during and after the procedure.
Measured: 1 minute before the procedure, iduring the procedure, 2 minutes after the procedure and 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 May 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Aytekin Ozdemir, Istanbul Medeniyet University
- Investigators
- Aynur Aytekin Ozdemir, Professor, Study director, İstanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959290
- Sponsor's protocol ID
- 01.11.2024/21
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants: A Randomised Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT06959290
- Acronym / sponsor ID
- 01.11.2024/21
- Conditions
- Premature Infant, Retinopaty of Prematurity, Pain Management
- Keywords
- Premature Infant, Retinopaty of prematurity examination, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 6 May 2025 (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 will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).
Detailed description
Retinopathy of prematurity (ROP) examination is performed using a binocular indirect ophthalmoscope. ROP examination causes pain and discomfort in the preterm infant in many ways, including the application of eye drops, the placement of the speculum in the eye, the pressure applied to the pupils and the brightness of the ophthalmoscope. Studies in the literature have also reported that newborns experience pain and discomfort during ROP examination. In relation to the ROP pain experienced by the preterm infant, various physiological changes such as increased heart rate or decreased oxygen saturation are experienced during or after the examination. Accordingly, ROP examination is important; however, controlling the pain that occurs during the examination is also very important in terms of the patient's emotional experience and comfort. In the literature, many studies have been conducted to reduce pain during ROP examination. Although pharmacological treatment methods are an effective technique to reduce pain, it is recommended that nonpharmacological methods should be used especially in infants and children because of the side effects of drugs (such as apnoea, bradycardia, respiratory depression, hypotension) and the method to be used should be easy, fast and does not require preparation. The Turkish Neonatology Society and the Turkish Ophthalmology Society also recommend that ROP examination is a very painful procedure, that pharmacological methods alone are not sufficient to reduce pain, and that nonpharmacological methods such as pacifier, breast milk and oral sucrose should be used during the examination. In addition, although there is no gold standard for pain relief during ROP examination, previous studies suggest that clinicians should use more than one method together to reduce pain and provide relief in premature infants. In this study, a combination of oral 25% dextrose, non-nutritive sucking and swaddling will be used for multiple nonpharmacological applications
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Routine TreatmentRetinopathy of prematurity examination will be performed according to clinical routine practice. |
| Intervention Group | Active comparator | Procedure: Multiple nonpharmacological methodsMultiple nonpharmacological methods will be applied for pain management during retinopathy of prematurity examination. |
Who may qualify
- Ages
- 26 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Postmenstrual gestational age ≤32 weeks and/or birth weight ≤1500 g,
- Stable, awake, in supine position and breathing spontaneously without oxygen support,
- Vital signs were within normal limits before the examination,
- Premature infants undergoing ROP examination for the first time.
Key exclusion criteria (5 listed)
- Preterms who have been administered non-steroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital and diazepam within 24 hours before the ROP examination,
- Preterms with severe respiratory diseases, receiving respiratory support (continuous positive airway pressure or mechanical ventilation),
- Preterms with critical conditions such as central nervous system infections and sepsis,
- Preterms with other organic diseases such as severe cardiovascular disease, pulmonary insufficiency,
- Preterms with congenital malformations.
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 |
|---|---|---|
| Multiple nonpharmacological methodsThe preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. The nurse will then give the baby 25% dextrose solution orally (0.5ml for those <32 weeks gestation, 1ml for those >32 weeks gestation). The nurse then places a pacifier soaked in 25% dextrose solution in the preterm infant's mouth. After these three non-pharmacological methods, the doctor will perform the ROP examination. | Procedure or surgery | Intervention Group |
| Routine TreatmentThe preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. After these three non-pharmacological methods, the doctor will perform the ROP examination. | Other | Control Group |
Primary outcome
Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R)
Time frame: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure
The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of <7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.
2 secondary outcomes
Oxygen saturation
Time frame: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure
Heart rate
Time frame: 1 minute before the procedure, iduring the procedure, 2 minutes after the procedure and 5 minutes after the procedure
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 14 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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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.
Aynur Aytekin Ozdemir, Professor study director
İstanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple nonpharmacological methods and Routine Treatment in people with Premature Infant and Retinopaty of Prematurity, run by Istanbul Medeniyet University 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 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 14 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R) (time frame: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure). 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 14 Jul 2025.