Clinical trial NCT06348641: Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination
Official title: The Effect of Massage Applied Before The Retinopathy of Prematurity Examination on the Pain Level and Comfort of the Newborn
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Retinopathy of Prematurity
Premature Baby 26 to 32 Weeks
Premature Baby 33 to 36 Weeks
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.

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.


Eligibility criteria: Inclusion Criteria:

* \<32 gestational age
* Birth weight of \<1500g
* Who were clinical stable
* Baby's first eye examination
* The baby's family has permission

Exclusion Criteria:

* Infants with previous ROP examination
* Lack of mechanical ventilator support
* Major congenital anomaly
* Intraventriculer bleeding
* Receiving analgesic medication

Primary outcomes:
measure: Pain during examination for retinopathy of prematurity
timeFrame: Before, during and after ROP examination
Secondary outcomes:
measure: Comfort during retinopathy of prematurity examination
timeFrame: Before, during and after ROP examination
Other outcomes:
Locations:
Study officials:
References: