Clinical trial NCT05263973: The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity Retinopathy Examination
Official title: The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ROP Examination
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 28
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Music
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is planned to determine the effect of music during Retinopathy of Prematurity (ROP) examination on pain, comfort and physiological parameters in preterm infants. This is single-center, randomized controlled trial, double blind, parallel.

Hypotheses:

H1: The music applied during the ROP examination has an effect on the Revised Premature Infant Pain Profile (PIPP-R) score of the preterm infant.

H2: The music applied during the ROP examination has an effect on the Preterm Infant Comfort Scale (PMI) score of the preterm infant.

H3: Music applied during the ROP examination has an effect on the physiological parameters (peak heart rate, O2 saturation) of the preterm infant.

H4: The music applied during the ROP examination has an effect on the crying time of the preterm infant during the procedure.

Method: The study will be performed with preterm infants (n=28) hospitalized in the neonatal intensive care unit of a tertiary hospital. Premature infants to be included in the study will be assigned to two study groups using the block randomization method created in the computer environment according to their gestational age, gender, birth weight.

The data in the study were will be collected using the Questionaire Form for Preterm Newborns and Their Parents, Physiological Parameters Observation Form, Revised-Premature Infant Pain Profile (PIPP-R), Premature Infant Comfort Scale (PICS), Pulse Oximeter, Music CD, Music box, Video camera, decibel meter, tripod. Data will be collected by researcher ABÇ. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study.

Questionaire Form for Preterm Newborns and Their Parents will be obtained from the nurse observation form and patient files. Four minutes before the ROP, the infant will be monitored and physiological parameters will be recorded, and three minutes before the ROP, the experimental group will start to listen to music (Video recordings will be evaluated by three experts, PIPP-R and PICS). The music recording will continue to be played during the ROP examination for music group. No application will be made for the control group other than the clinical routines.

Detailed description: This randomized controlled experimental study is planned in order to determine the effect of music on pain, comfort and physiological parameters in preterm infants in ROP examination matched for gestational age, gender and birth weight. The research sample will consist of 28 preterm infants who meet the inclusion criteria. In the literature, the number of infants varies between 10 and 30 in different studies in which music was applied to preterm infants. In this study, it was decided that the number of infants in the groups should be 14 according to α=95% confidence level and 90% power. In the study, it was planned to have 14 infants in the music and control groups. After reaching 28 preterm infants in the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not. All bodies of preterm infants will be recorded with a visible video camera for an average of 10 minutes, 4 minutes before the start of the ROP examination and 4 minutes after the completion of the ROP examination (for PIPP-R and PICS scores). The infants in the music group (Acem Aşiran Maqam music prepared by TÜMATA group) will be applied music for a about total of 10 minutes, starting 3 minutes before the ROP examination and continuing during the ROP examination, 3 minutes after ROP examination. After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 45 cm from the head of infant and the sound level will be adjusted to an average of 45-60 decibels. The examination will begin with the placement of the speculum in the eye. The duration of the examination varies according to the visibility of the retinal vascularity, and the examination will end with the removal of the speculum from the eye (mean ROP time 1.61 ±1.59). The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made. Data will be collected with the Questionaire Form for Preterm Newborns and Their Parents, Physiological Parameters Observation Form, Revised-Premature Infant Pain Profile (PIPP-R), Premature Infant Comfort Scale (PICS), Pulse Oximeter, Music CD, Music box, Video camera, decibel meter, tripod.

Eligibility criteria: Inclusion Criteria:

* Birth weight \<2000 g,
* Gestational age ≤32 weeks,
* Have not passed the first 2 ROP inspections,
* Not receiving ventilatory support (not intubated or positive pressure ventilation support) for the last 72 hours,
* Vital signs within normal limits (without tachycardia, tachypnea, hyperthermia, hypothermia, dyspnea, intercostal or subcostal retraction),
* Not having any congenital anomalies (eye, neurological) that may adversely affect the examination,
* No hearing problem,
* No painful intervention is performed at least 30 minutes before the ROP examination,
* Preterm newborns whose corrected/postnatal age is 28-36 weeks at the time of examination,
* Newborns whose mothers want to participate in the study will be included in the study.

Exclusion Criteria:

* Clinic condition worsening during working,
* Diagnosed with hydrocephalus, necrotizing enterocolitis, indirect hyperbilirubinemia,
* Receiving analgesic treatment,
* Newborns whose mothers want to withdraw from the study will be excluded from the study groups.

Primary outcomes:
measure: Premature Infant Comfort Scale (PBIC)
timeFrame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
measure: Premature Baby Pain Profile Scale-Revised Form (PIPP-R)
timeFrame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
measure: Physiological parameters- heart rate
timeFrame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
measure: Physiological parameters- oxygen saturation
timeFrame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
measure: Physiological parameters- respiratory rate
timeFrame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
measure: Physiological parameters- crying time
timeFrame: immediately after the ROP examination.
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes university
Study officials:
affiliation: TC Erciyes University
name: Yağmur Sezer Efe, Assist. Prof.
role: PRINCIPAL_INVESTIGATOR
References: