Retinopathy of Prematurity (ROP)NCT06694103
The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
A study testing Reverse Kangaroo Care Position and ROP Position in people with Retinopathy of Prematurity (ROP), run by Sinem Basdemir at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled trial is to determine the effect of reverse kangaroo care position and ROP (Retinopathy of Prematurity) position applied during ROP examination in premature infants on pain. The main questions it aims to answer are as follows: 1. Read more about this study
- Who is it for?
- Ages 28 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- Reverse Kangaroo Care Position and ROP Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2024to 30 Jul 2025
- 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 28 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age <34 weeks,
- Birth weight ≤ 2500 grams,
- No painful interventions at least 1 hour before the ROP examination,
- Fed at least 1 hour before the ROP examination,
- Premature infants whose parents consented to participate in the study.
Who cannot join
- Having a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental delay etc.)
- Any congenital anomaly (eye, neurological, etc.),
- Have a diagnosed hearing problem,
- A different painful procedure was performed at least one hour before the ROP examination,
- Administration of an analgesic/sedative medication before the examination,
- Premature infants whose parents did not consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital
Izmir, Menemen, 35610
Sinem Başdemir, Research Assistant, +905550074974, sinem.basdemir@bakircay.edu.tr
Hatice Bal Yılmaz, Prof. Dr., +905321323756, hatice.bal.yilmaz@ege.edu.tr
About this study
Official title: The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants
The goal of this randomized controlled trial is to determine the effect of reverse kangaroo care position and ROP (Retinopathy of Prematurity) position applied during ROP examination in premature infants on pain. The main questions it aims to answer are as follows:
- Is the reverse kangaroo care position effective in reducing the pain of premature infants during the ROP examination?
- Is the reverse kangaroo care position more effective in reducing the pain of premature infants compared to the ROP position during the ROP examination?
Read more
Researchers will determine the effect of reverse kangaroo care position and ROP position applied during premature retinopathy examination in premature infants with a gestational age of less than 34 weeks on pain in infants.
- The infants of parents who volunteer to participate in the study will be divided into two groups as Reverse Kangaroo Care Position group and ROP Position group according to randomization.
- From the infants whose pupils are sufficiently mydriasis and are taken to the examination table, premature infants in the ROP Position group will be given ROP position together with the nurse and the parent.
- Premature infants in the Reverse Kangaroo Care Position group will be given reverse kangaroo care position.
- Video recording will be made during the given positions.
- The effects of the applied positions on pain will be determined as a result of the measured parameters before, during and after the examination.
Read the detailed description
- 84 premature infants that meet the sample criteria will be determined.
- Randomization will be performed and premature babies will be assigned to the Reverse Kangaroo Care Position (Group 1) and Rope Position (Group 2) groups.
- The purpose of the study will be explained to the mother by meeting her and written consent will be obtained.
- The Premature Identification Form, which includes information about the infant, will be filled out.
According to the groups to which the premature infants who were randomized were assigned;
One minute before the examination;
- The infants will be placed on the examination table and one drop of %0.5 alcaine (proparacaine HCl) topical anesthetic eye drops will be applied to both eyes of the premature infantss assigned to both groups by the neonatal intensive care nurse.
- The pulse oximetry probe will be attached to the infants' right feet and monitored.
- The infants will be positioned according to the group they are assigned to.
- Video recording will be started one minute before the examination and will continue until 1 minute after the examination.
- In order to evaluate the SPO2, KTA, PIPP-R values of all groups at the 15th second before the examination, the infant will be recorded on video for one minute.
During the Examination; In the Reverse Kangaroo Care Position Group;
- While the reverse kangaroo care position applied to the infants is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
- The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation
In the ROP Position Group;
- While the ROP position applied to the babies is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
- The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation
At the end of the examination;
- After the completion of both eye examinations, the video recording will continue for 1 more minute while the positions of the babies whose monitoring continues are maintained
- The video recording will end 1 minute after the examination ends
- The infant's SPO2, KTA, values, PIPP-R pain score will be evaluated and recorded
- . The aim is to record the infant's SPO2 and KTA values at 30 seconds so that the PIPP-R pain score can be evaluated later.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- Reverse Kangaroo Care Position, ROP Position
- Keywords
- Premature, Retinopathy Screening, Retinopathy of Prematurity (ROP), Reverse Kangaroo Care Position, Pain
- Medical subject headings
- Retinopathy of Prematurity, Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Kangaroo Care PositionOther
- Babies will be taken to the examination table and their clothes other than diapers will be removed.
- Mothers will take off their upper clothes and lie on the examination table and position their babies in the reverse kangaroo care position, with the baby's back against the mother's bare chest.
- Babies will be monitored with disposable probes from their right feet.
- Video recording will be started. -While the position applied to the babies is maintained, the speculum will be placed in the eye by the ophthalmologist and the examination will be recorded on video from the beginning to end.
- After the completion of both eye examinations, the position of the babies whose monitoring continues will be maintained while the video recording will be taken for another 1 minute. The SPO2, HR, PIPP-R score at the end of the 15th second before the examination, the first minute during the examination and the 30th second after the examination will be evaluated.
ROP PositionOther
- Babies will be taken to the examination table and monitored with disposable probes from their right feet.
- The nurse will place the infant's own palms on the temporal region and hold them with her hands to support their head, while the mother will also support the infant by holding their legs.
- The video recording will be started.
- SPO2, HR, PIPP-R values will be recorded on video for one minute.
- While the ROP position applied to the babies is maintained, the speculum is placed in the eye by the ophthalmologist and the examination begins.
- SPO2, HR, PIPP-R evaluation at the 1st minute of the examination.
- After the completion of both eye examinations, the babies whose monitoring continues will be kept in their positions and a video recording will be taken for another 1 minute.
- The SPO2, HR values and PIPP-R pain score at the end of the 30 seconds after the examination will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Reverse Kangaroo Care Position Group | Experimental | The advantages of kangaroo care will be utilised in the ROP examination. By reversing the position of the baby's face to the mother's breast, a change in the traditional kangaroo care posture will be applied, called the reverse kangaroo care position. Premature infants will be placed on the examination table for ROP examination and the infants' clothes other than diapers will be removed. Mothers will lie on the examination table by removing their upper clothes and their infants will be positioned in the inverted kangaroo care position, with the infant's back resting between the mother's bare chest. The privacy of the mother and the infant will be ensured and the infant will be able to smell the mother's scent with a piece of clothing taken off by the mother. Receives: Other: Reverse Kangaroo Care Position |
| ROP Position Group | Experimental | The position is given while the premature infant is in the supine position with the presence of two people (mother and nurse). It is performed in two stages by positioning the lower and upper extremities of the premature infant. The feet and legs are in the lower extremities, and the arms and head are in the upper extremities. During the examination, the premature infant's head is in slight hyperextension so that the retinal maneuvers applied by the ophthalmologist can be easily performed. The nurse places the infant's own palms on the temporal region and supports the head by holding it with her hands, while the mother supports the infant by bringing the infant's legs together and pushing it towards her abdomen. Receives: Other: ROP Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Introductory Information Form:
It was prepared by the researcher to determine the characteristics of the premature babies participating in the study. It consists of seven questions including the baby's gender, gestational week, birth weight, postnatal week, delivery method, birth head circumference and height measurement.
Measured: Pre-intervention
Premature Infant Follow-up Form
It consists of fields including the premature infant's heart rate, oxygen saturation values and PIPP-R score at the 15th second before the examination, the 1st minute during the examination and the 30 seconds after the examination.
Measured: 15th minute before the examination; 1st minute during the examination, 30 seconds after the examination
Premature Infant Pain Profile Scale-Revised Form (PIPP-R)
It is a Likert-type scale. In the scoring of the scale, items related to physiological and behavioral indicators are scored as 0, 1, 2 and 3 points for each variable. Items related to contextual indicators (behavioral status and gestational age) are scored as 3, 2, 1 and 0 points at the beginning of the pain assessment (before contact with the baby). According to PIPP-R, the infant's pain is evaluated based on the total score. In scoring the PIPP-R, behavioral and physiological indicators are scored at the end of the scale. Accordingly, if the infant receives a zero score (subtotal) from the general physiological and behavioral indicators, the contextual indicators are not scored. If the infant receives a score above zero from the initial parameters, the total score is obtained by including the contextual indicators in the scoring. The highest score of the PIPP-R is 21 for preterm infants and 18 for term infants (Stevens et al., 2014).
Measured: 15th second before the examination; 1st minute during the examination, 30 seconds after the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start19 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
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 Retinopathy of Prematurity (ROP)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinem Basdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sinem Basdemir, Ege University
- Investigators
- Hatice Bal Yılmaz, Prof. Dr., Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694103
- Sponsor's protocol ID
- EU-HEM-SB-01
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only IPD used in the results publication. It will be shared later.
Publications
Basdemir S, Bal Yilmaz H. The effect of reverse kangaroo care position and ROP position on pain during retinopathy examination in premature infants: A randomized controlled trial. J Pediatr Nurs. 2026 Aug 25;91:428-437. doi: 10.1016/j.pedn.2026.08.026. Online ahead of print.
PubMed 42641311
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants
- ClinicalTrials.gov ID
- NCT06694103
- Acronym / sponsor ID
- EU-HEM-SB-01
- Conditions
- Retinopathy of Prematurity (ROP)
- Keywords
- Premature, Retinopathy Screening, Retinopathy of Prematurity (ROP), Reverse Kangaroo Care Position, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sinem BasdemirUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 19 Nov 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.
The goal of this randomized controlled trial is to determine the effect of reverse kangaroo care position and ROP (Retinopathy of Prematurity) position applied during ROP examination in premature infants on pain. The main questions it aims to answer are as follows:
- Is the reverse kangaroo care position effective in reducing the pain of premature infants during the ROP examination?
- Is the reverse kangaroo care position more effective in reducing the pain of premature infants compared to the ROP position during the ROP examination?
Researchers will determine the effect of reverse kangaroo care position and ROP position applied during premature retinopathy examination in premature infants with a gestational age of less than 34 weeks on pain in infants.
- The infants of parents who volunteer to participate in the study will be divided into two groups as Reverse Kangaroo Care Position group and ROP Position group according to randomization.
- From the infants whose pupils are sufficiently mydriasis and are taken to the examination table, premature infants in the ROP Position group will be given ROP position together with the nurse and the parent.
- Premature infants in the Reverse Kangaroo Care Position group will be given reverse kangaroo care position.
- Video recording will be made during the given positions.
- The effects of the applied positions on pain will be determined as a result of the measured parameters before, during and after the examination.
Detailed description
- 84 premature infants that meet the sample criteria will be determined.
- Randomization will be performed and premature babies will be assigned to the Reverse Kangaroo Care Position (Group 1) and Rope Position (Group 2) groups.
- The purpose of the study will be explained to the mother by meeting her and written consent will be obtained.
- The Premature Identification Form, which includes information about the infant, will be filled out.
According to the groups to which the premature infants who were randomized were assigned;
One minute before the examination;
- The infants will be placed on the examination table and one drop of %0.5 alcaine (proparacaine HCl) topical anesthetic eye drops will be applied to both eyes of the premature infantss assigned to both groups by the neonatal intensive care nurse.
- The pulse oximetry probe will be attached to the infants' right feet and monitored.
- The infants will be positioned according to the group they are assigned to.
- Video recording will be started one minute before the examination and will continue until 1 minute after the examination.
- In order to evaluate the SPO2, KTA, PIPP-R values of all groups at the 15th second before the examination, the infant will be recorded on video for one minute.
During the Examination; In the Reverse Kangaroo Care Position Group;
- While the reverse kangaroo care position applied to the infants is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
- The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation
In the ROP Position Group;
- While the ROP position applied to the babies is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
- The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation
At the end of the examination;
- After the completion of both eye examinations, the video recording will continue for 1 more minute while the positions of the babies whose monitoring continues are maintained
- The video recording will end 1 minute after the examination ends
- The infant's SPO2, KTA, values, PIPP-R pain score will be evaluated and recorded
- . The aim is to record the infant's SPO2 and KTA values at 30 seconds so that the PIPP-R pain score can be evaluated later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reverse Kangaroo Care Position Group | Experimental | Other: Reverse Kangaroo Care PositionThe advantages of kangaroo care will be utilised in the ROP examination. By reversing the position of the baby's face to the mother's breast, a change in the traditional kangaroo care posture will be applied, called the reverse kangaroo care position. Premature infants will be placed on the examination table for ROP examination and the infants' clothes other than diapers will be removed. Mothers will lie on the examination table by removing their upper clothes and their infants will be positioned in the inverted kangaroo care position, with the infant's back resting between the mother's bare chest. The privacy of the mother and the infant will be ensured and the infant will be able to smell the mother's scent with a piece of clothing taken off by the mother. |
| ROP Position Group | Experimental | Other: ROP PositionThe position is given while the premature infant is in the supine position with the presence of two people (mother and nurse). It is performed in two stages by positioning the lower and upper extremities of the premature infant. The feet and legs are in the lower extremities, and the arms and head are in the upper extremities. During the examination, the premature infant's head is in slight hyperextension so that the retinal maneuvers applied by the ophthalmologist can be easily performed. The nurse places the infant's own palms on the temporal region and supports the head by holding it with her hands, while the mother supports the infant by bringing the infant's legs together and pushing it towards her abdomen. |
Who may qualify
- Ages
- 28 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age <34 weeks,
- Birth weight ≤ 2500 grams,
- No painful interventions at least 1 hour before the ROP examination,
- Fed at least 1 hour before the ROP examination,
- Premature infants whose parents consented to participate in the study.
Key exclusion criteria (6 listed)
- Having a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental delay etc.)
- Any congenital anomaly (eye, neurological, etc.),
- Have a diagnosed hearing problem,
- A different painful procedure was performed at least one hour before the ROP examination,
- Administration of an analgesic/sedative medication before the examination,
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 |
|---|---|---|
| Reverse Kangaroo Care Position* Babies will be taken to the examination table and their clothes other than diapers will be removed. * Mothers will take off their upper clothes and lie on the examination table and position their babies in the reverse kangaroo care position, with the baby's back against the mother's bare chest. * Babies will be monitored with disposable probes from their right feet. * Video recording will be started. -While the position applied to the babies is maintained, the speculum will be placed in the eye by the ophthalmologist and the examination will be recorded on video from the beginning to end. * After the completion of both eye examinations, the position of the babies whose monitoring continues will be maintained while the video recording will be taken for another 1 minute. The SPO2, HR, PIPP-R score at the end of the 15th second before the examination, the first minute during the examination and the 30th second after the examination will be evaluated. | Other | Reverse Kangaroo Care Position Group |
| ROP Position* Babies will be taken to the examination table and monitored with disposable probes from their right feet. * The nurse will place the infant's own palms on the temporal region and hold them with her hands to support their head, while the mother will also support the infant by holding their legs. * The video recording will be started. * SPO2, HR, PIPP-R values will be recorded on video for one minute. * While the ROP position applied to the babies is maintained, the speculum is placed in the eye by the ophthalmologist and the examination begins. * SPO2, HR, PIPP-R evaluation at the 1st minute of the examination. * After the completion of both eye examinations, the babies whose monitoring continues will be kept in their positions and a video recording will be taken for another 1 minute. * The SPO2, HR values and PIPP-R pain score at the end of the 30 seconds after the examination will be evaluated. | Other | ROP Position Group |
Primary outcome
Premature Introductory Information Form:
Time frame: Pre-intervention
It was prepared by the researcher to determine the characteristics of the premature babies participating in the study. It consists of seven questions including the baby's gender, gestational week, birth weight, postnatal week, delivery method, birth head circumference and height measurement.
Premature Infant Follow-up Form
Time frame: 15th minute before the examination; 1st minute during the examination, 30 seconds after the examination
It consists of fields including the premature infant's heart rate, oxygen saturation values and PIPP-R score at the 15th second before the examination, the 1st minute during the examination and the 30 seconds after the examination.
Premature Infant Pain Profile Scale-Revised Form (PIPP-R)
Time frame: 15th second before the examination; 1st minute during the examination, 30 seconds after the examination
It is a Likert-type scale. In the scoring of the scale, items related to physiological and behavioral indicators are scored as 0, 1, 2 and 3 points for each variable. Items related to contextual indicators (behavioral status and gestational age) are scored as 3, 2, 1 and 0 points at the beginning of the pain assessment (before contact with the baby). According to PIPP-R, the infant's pain is evaluated based on the total score. In scoring the PIPP-R, behavioral and physiological indicators are scored at the end of the scale. Accordingly, if the infant receives a zero score (subtotal) from the general physiological and behavioral indicators, the contextual indicators are not scored. If the infant receives a score above zero from the initial parameters, the total score is obtained by including the contextual indicators in the scoring. The highest score of the PIPP-R is 21 for preterm infants and 18 for term infants (Stevens et al., 2014).
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 19 Nov 2024.
- Derived from this study: PubMed 42641311Basdemir S, Bal Yilmaz H. The effect of reverse kangaroo care position and ROP position on pain during retinopathy examination in premature infants: A randomized controlled trial. J Pediatr Nurs. 2026 Aug 25;91:428-437. doi: 10.1016/j.pedn.2026.08.026. Online ahead of print.
- Individual participant dataSharing planned: No. Only IPD used in the results publication. It will be shared later.
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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.
Hatice Bal Yılmaz, Prof. Dr. principal investigator
Ege 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 Reverse Kangaroo Care Position and ROP Position in people with Retinopathy of Prematurity (ROP), run by Sinem Basdemir 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 5 inclusion and 6 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 19 Nov 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?
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 Sinem Başdemir, Research Assistant (+905550074974, sinem.basdemir@bakircay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Introductory Information Form: (time frame: Pre-intervention). The study lists 3 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 NCT06694103, 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 19 Nov 2024.