Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination

NCT06348641 | Not Yet Recruiting

• 1 other identifier: 2011-KAEK-25 2022/12-11
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pain during examination for retinopathy of prematurity

  Reducing the premature baby pain scale score of the experimental group compared to the control group. It is suitable for term and preterm babies and is used to evaluate acute and procedural pain. Scoring ranges from 0 to 21, with a score of six or lower being considered as no or minimal pain, between 7-12 points as moderate pain, and between 13-21 points as severe pain. It is evaluated 15 seconds before the intervention and 30 seconds after the intervention.

  Before, during and after ROP examination

Secondary Outcomes (1)

• Comfort during retinopathy of prematurity examination

  Before, during and after ROP examination

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Other: baby massage

control group

NO INTERVENTION

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.

Interventions

baby massage OTHER

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.

experimental group

Eligibility Criteria

• Age: 1 Day - 40 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nurgül Tekin: lead

MeSH Terms

Conditions

Pain; Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Nurgül TEKIN

CONTACT

0224 295 50 00; nurgulkrtls@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 5, 2024
• Study Start: April 20, 2024
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share