Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination

Nurgül Tekin

Status: Not yet enrolling

Conditions: Retinopathy of Prematurity; Premature Baby 26 to 32 Weeks; Pain; Premature Baby 33 to 36 Weeks

Treatments: Other: baby massage

Study type: Interventional

Funder types: Other

Identifiers

NCT06348641

2011-KAEK-25 2022/12-11

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 40 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Other: baby massage

control group

No Intervention group

Description:

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.