Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination

Pain Clinical Trial

Official title:

The Effect of Massage Applied Before The Retinopathy of Prematurity Examination on the Pain Level and Comfort of the Newborn

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348641
• Other study ID #: 2011-KAEK-25 2022/12-11
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: April 20, 2025

Study information

• Verified date: April 2024
• Source: Uludag University
• Contact: Nurgül TEKIN
• Phone: 0224 295 50 00
• Email: nurgulkrtls[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 20, 2025
• Est. primary completion date: April 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 40 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Premature Baby 26 to 32 Weeks
• Premature Baby 33 to 36 Weeks
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nurgül Tekin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comfort during retinopathy of prematurity examination	Reducing the premature baby comfort scale score of the experimental group compared to the control group.; It is a multidimensional scale used to evaluate behavioral and psychological comfort and pain. Premature baby comfort scale evaluates 7 parameters such as Alertness, Calm/Agitation, Respiratory Status (only in mechanical ventilation support) or Crying (not evaluated because it is scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each item is a 5-point Likert type, scored from 1 to 5, from worst to best.; According to the scale, 35 indicates the lowest and 7 indicates the highest comfort score. A high score from the scale indicates that the comfort level is low. If the total score obtained is =17, it is the cut-off value of the scale, it is the limit value for the baby's comfort level and indicates the need for a pain-reducing intervention.	Before, during and after ROP examination