Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination
NCT ID: NCT06348641
Last Updated: 2024-04-05
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-20
2025-04-20
Brief Summary
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This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.
Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.
The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.
Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.
The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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experimental group
Babies in intervention classes will receive baby massage before the examination. Pre-examination baby massage will be applied by a single nurse = researcher. Video recording will be taken before and during the ROP examination, and evaluations will be made by two neonatal nurses other than the researcher.
Babies will be massaged by the researcher in accordance with IAIM rules and massage techniques. The total massage time will be equal for each baby.
baby massage
The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.
control group
For the control group, the routine retinopathy examination of the unit will be performed without any intervention.
Video recording will be taken before and during the ROP examination, and evaluations will be made by two neonatal nurses other than the researcher.
No interventions assigned to this group
Interventions
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baby massage
The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.
Eligibility Criteria
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Inclusion Criteria
* Birth weight of \<1500g
* Who were clinical stable
* Baby's first eye examination
* The baby's family has permission
Exclusion Criteria
* Lack of mechanical ventilator support
* Major congenital anomaly
* Intraventriculer bleeding
* Receiving analgesic medication
1 Day
40 Days
ALL
No
Sponsors
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Nurgül Tekin
OTHER
Responsible Party
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Nurgül Tekin
Principal Investigator
Central Contacts
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Other Identifiers
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2011-KAEK-25 2022/12-11
Identifier Type: -
Identifier Source: org_study_id
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