Premature RetinopathyNCT05830409
Multisensory Stimulation in Infants for Eye Examination
A study testing Multisensorial Stimulation in people with Premature Retinopathy and Pain, Eye, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns. It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Read more about this study
- Who is it for?
- Ages 32 weeks to 36 months
- Conditions the study is for
- Premature Retinopathy, Pain, Eye
- What is being tested?
- Multisensorial Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 weeks to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- According to the registry, premature neonates with a gestational age of ≤ 32 weeks or newborns with a birth weight of < 1500 g.
- Newborns undergoing a first-time eye exam to screen for retinopathy of prematurity.
Who cannot join
- Newborns who need CPR during the examination.
- Newborns experience apnea during the examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Multisensory Stimulation on Pain During the Preterm Infant's Eye Examination
This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns.
It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.
Read the detailed description
Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this population undergoes eye examinations at regular intervals. This procedure is painful procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized controlled trial and routine care were planned in the control group. Neonatal pain will be assessed using the PIPP scale.
- Conditions
- Premature Retinopathy, Pain, Eye
- Being tested
- Multisensorial Stimulation
- Keywords
- preterm infants, Multisensorial stimulation
- Medical subject headings
- Retinopathy of Prematurity, Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensorial StimulationBehavioural
Strategies such as touching, calling, making sense of smell, entering the eye area, and activating the sense of taste will be applied to activate the five senses of the newborn.
| Study group | Role | What they receive |
|---|---|---|
| Multisensorial Stimulation Group | Experimental | Preterm newborns who will receive multisensory stimulation during the eye examination. Receives: Behavioral: Multisensorial Stimulation |
| Control Group | No intervention | Preterm newborns who will receive routine care during the eye examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.
Measured: first 30 minutes during procedure
Secondary outcomes (2)
Heart rate
defines the newborn's heart rates per minutes.
Measured: first 30 minutes during procedure
Oksigen saturation
defines the newborn's Oksigen saturation
Measured: first 30 minutes during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start6 Jun 2023
- Primary completion4 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature RetinopathyStudies 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
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Burdur Mehmet Akif Ersoy University
- Responsible party
- Principal investigator, Halil Ibrahim Tasdemir, Akdeniz University
- Investigators
- Halil I Taşdemir, PhD, Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830409
- Sponsor's protocol ID
- MAKU23-1
- Status last verified
- Dec 2023
- First submitted
- 29 Mar 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be decided later
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multisensory Stimulation on Pain During the Preterm Infant's Eye Examination
- ClinicalTrials.gov ID
- NCT05830409
- Acronym / sponsor ID
- MAKU23-1
- Conditions
- Premature Retinopathy, Pain, Eye
- Keywords
- preterm infants, Multisensorial stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Burdur Mehmet Akif Ersoy University
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 26 Apr 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.
This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns.
It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.
Detailed description
Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this population undergoes eye examinations at regular intervals. This procedure is painful procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized controlled trial and routine care were planned in the control group. Neonatal pain will be assessed using the PIPP scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensorial Stimulation Group | Experimental | Behavioral: Multisensorial StimulationPreterm newborns who will receive multisensory stimulation during the eye examination. |
| Control Group | No intervention | –Preterm newborns who will receive routine care during the eye examination |
Who may qualify
- Ages
- 32 weeks to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- According to the registry, premature neonates with a gestational age of ≤ 32 weeks or newborns with a birth weight of < 1500 g.
- Newborns undergoing a first-time eye exam to screen for retinopathy of prematurity.
Key exclusion criteria (2 listed)
- Newborns who need CPR during the examination.
- Newborns experience apnea during 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 |
|---|---|---|
| Multisensorial StimulationStrategies such as touching, calling, making sense of smell, entering the eye area, and activating the sense of taste will be applied to activate the five senses of the newborn. | Behavioural | Multisensorial Stimulation Group |
Primary outcome
Pain level
Time frame: first 30 minutes during procedure
Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.
2 secondary outcomes
Heart rate
Time frame: first 30 minutes during procedure
Oksigen saturation
Time frame: first 30 minutes during 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 22 Dec 2023.
- Individual participant dataSharing planned: No. will be decided later
Related trials for Premature Retinopathy
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
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.
Halil I Taşdemir, PhD principal investigator
Burdur Mehmet Akif Ersoy 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 Multisensorial Stimulation in people with Premature Retinopathy and Pain, Eye, run by Akdeniz 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 2 inclusion and 2 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 22 Dec 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?
Pain level (time frame: first 30 minutes during 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 22 Dec 2023.