The Effect of Ocean Sound In Premature Retinopathy Examination
Condition: Premature Retinopathy; Pain
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional

Summary: 
      Purpose: It was planned as a randomized controlled experiment in order to evaluate the
      effectiveness of the ocean sound on pain, comfort and physiological parameters in the NICU,
      Retinopathy of Prematurity (ROP) examination.

      Design: This is single-center. randomized controlled trial, double blind, parallel.

      Hypotheses:

      H0a: There is no difference between the pain levels (scale score) of premature babies in the
      control group and the ocean sound group.

      H0b: There is no difference between the comfort levels (scale score) of premature babies in
      the control group and the ocean sound group.

      H0c: There is no difference between the physiological parameters of the premature babies in
      the control group and the ocean sound group.

      H1a: There is a difference between the pain levels (scale score) of premature babies in the
      control group and the ocean sound group.

      H1b: There is a difference between the comfort levels (scale score) of premature babies in
      the control group and the ocean sound group.

      H1c: There is a difference between the physiological parameters of the premature babies in
      the control group and the ocean sound group.

      Method:

      The population of the research will be preterm babies who are treated at Necmettin Erbakan
      University Meram Medical Faculty NICU and will have their first ROP examination.

      Premature babies to be included in the study will be assigned to two study groups using the
      quadruple balanced block randomization method created in the computer environment according
      to their gestational age.

      In the study, the baby information form, Premature Baby Pain Profile Scale-Revised Form
      (PIPP-R), and Premature Baby Comfort Scale (PBIC) created by the researcher by scanning the
      literature will be used.

      Data will be collected by researcher GA. Infants who meet the criteria for inclusion in the
      study will be selected from the infants who are planned to undergo an ROP examination, and
      written and verbal consent will be obtained from the families by explaining the purpose of
      the study before the application.

      The information contained in the "Baby Information Form" will be obtained from the nurse
      observation form and patient files. On the day of the ROP examination, babies who meet the
      inclusion criteria before the procedure will be recorded outside the incubator with a video
      recorder in the room where the ROP examination will be performed (a room with 45-50 dB
      sound). Two minutes before the ROP, the baby will be monitored and physiological parameters
      will be recorded, and one minute before the ROP, the experimental group will start to listen
      to the ocean sound (Video recordings will be evaluated by two experts, PIPP-R and PBIC).
      After the necessary disinfection process is done, the voice recorder will be placed in the
      incubator at a distance of 20 cm from the baby's head and the sound level will be adjusted to
      an average of 55 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.
      Ocean Sound Group; The ocean sound recording will continue to be played during the ROP
      examination. Control Group; No sound will be played before, during and after the ROP
      examination.

      Physiological parameters will be recorded at the 1st and 5th minutes after the procedure.
      (Video recordings will be evaluated by two experts for PIPP-R and PBIC). Video recording will
      be stopped.Ocean Sound Group;The ocean sound recording will be played at the 5th minute after
      the ROP inspection. Control Group; No sound will be played before, during and after the ROP
      examination.
    


Intervention name(s): Ocean sound; Routine
Intervention type(s): Other; Other
Intervention description(s): The experimental group will listen to ocean sound, starting at the 1st minute before the ROP examination and ending at the 5th minute after the ROP examination.; No sound will be played before, during and after the ROP examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care