PainNCT04463927
The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity
A study testing non-nutritive sucking in people with Pain, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity. Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. Read more about this study
- Who is it for?
- Ages 28 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- non-nutritive sucking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2020to 9 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- having an examination for retinopathy of prematurity for the first time,
- age was between 28-35 weeks
Who cannot join
- having no congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity.
Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.
Read the detailed description
A topical anesthetic will be applied to all premature newborns 30 seconds before eye examination. Non-nutritive sucking is applied to the intervention group during the examination for retinopathy of prematurity. No method is applied to the control group during the examination for retinopathy of prematurity
- Conditions
- Pain
- Being tested
- non-nutritive sucking
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-nutritive suckingOther
intervention group received a sterile gloved finger during the examination for retinopathy of prematurity
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The non-nutritive sucking is applied to the group during the examination for retinopathy of prematurity Receives: Other: non-nutritive sucking |
| Control Group | No intervention | The non-nutritive sucking is not applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile
The primary outcome of the study is to evaluate the pain relief efficacy of non-nutritive sucking during examination for retinopathy of prematurity Premature Infant Pain Profile (PIPP).
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start10 May 2020
- Primary completion8 Aug 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Koc Ozkan, Adiyaman University
- Investigators
- Tuba KOÇ ÖZKAN, Principal investigator, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463927
- Sponsor's protocol ID
- 2020/2-16
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT04463927
- Acronym / sponsor ID
- 2020/2-16
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 9 Jul 2020 (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.
Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity.
Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.
Detailed description
A topical anesthetic will be applied to all premature newborns 30 seconds before eye examination. Non-nutritive sucking is applied to the intervention group during the examination for retinopathy of prematurity. No method is applied to the control group during the examination for retinopathy of prematurity
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: non-nutritive suckingThe non-nutritive sucking is applied to the group during the examination for retinopathy of prematurity |
| Control Group | No intervention | –The non-nutritive sucking is not applied to the control group. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- having an examination for retinopathy of prematurity for the first time,
- age was between 28-35 weeks
Key exclusion criteria (1 listed)
- having no congenital anomalies
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 |
|---|---|---|
| non-nutritive suckingintervention group received a sterile gloved finger during the examination for retinopathy of prematurity | Other | Intervention Group |
Primary outcome
Premature Infant Pain Profile
Time frame: 1 minute
The primary outcome of the study is to evaluate the pain relief efficacy of non-nutritive sucking during examination for retinopathy of prematurity Premature Infant Pain Profile (PIPP).
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 13 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuba KOÇ ÖZKAN principal investigator
Adiyaman 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 non-nutritive sucking in people with Pain, run by Adiyaman University Research Hospital 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 1 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 13 Aug 2021. 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?
Premature Infant Pain Profile (time frame: 1 minute). 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 13 Aug 2021.