xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05967572</url>
    </required_header>
    <id_info>
      <org_study_id>NecmettinEUSKose</org_study_id>
      <nct_id>NCT05967572</nct_id>
    </id_info>
    <brief_title>The Effect of Different Music Listened During Retinopathy Examination to Premature Infants</brief_title>
    <official_title>The Effect of Different Music Listened During Retinopathy Examination to Premature Infants on Their Pain and Comfort Level: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Necmettin Erbakan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Necmettin Erbakan University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Retinopathy of Prematurity (ROP); It is a disease of premature and low birth weight infants,&#xD;
        characterized by incomplete vascularization of the retina, etiology and pathogenesis of which&#xD;
        is unknown, and causes vision loss. There is an increase in the incidence and severity of ROP&#xD;
        development in direct proportion to the decrease in birth week and birth weight. While ROP is&#xD;
        a problem below 32 weeks of gestation in developed countries, it is reported to develop&#xD;
        severely up to 34 weeks of gestation in developing countries. In a multicenter study&#xD;
        conducted by the Turkish Neonatology Society in our country, the frequency of ROP in very low&#xD;
        birth weight preterm infants was found to be 42%, and the frequency of advanced ROP was 11%.&#xD;
        The incidence of ROP in babies with a gestational age of 33-35 weeks was 6.1%, and advanced&#xD;
        ROP was 6 per thousand. The frequency of ROP was found to be 10.3% in babies with a birth&#xD;
        weight of 1500-2000 grams, and severe ROP was reported in 19 of these babies. ROP examination&#xD;
        is a procedure that causes pain, deterioration in comfort and physiological changes in&#xD;
        preterm newborns. After this examination, an increase in blood pressure and heart rate and a&#xD;
        decrease in oxygen saturation are observed. Pharmacological and non-pharmacological&#xD;
        (non-pharmacological) methods are used to reduce the pain and increase the comfort level of&#xD;
        the premature newborn. As a pharmacological method, there is no other routine method used to&#xD;
        reduce pain other than the administration of local anesthetic drops before the examination.&#xD;
        Because of this situation, nurses apply various non-pharmacological methods to alleviate&#xD;
        pain. These methods are; breast milk, sucrose use, oral dextrose use, non-nutritive sucking,&#xD;
        positioning, listening to music and mother's voice. In the literature, no specific study was&#xD;
        found in which music was used to reduce pain and increase the comfort level during the ROP&#xD;
        examination. Therefore, this research will be carried out to determine the effect of&#xD;
        different music played on the pain and comfort level of premature babies during the&#xD;
        retinopathy examination.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Retinopathy of Prematurity (ROP); It is a disease characterized by incomplete vascularization&#xD;
        of the retina seen in premature and low birth weight infants, the etiology and pathogenesis&#xD;
        of which are unknown, causing vision loss. There is an increase in the incidence and severity&#xD;
        of ROP development in direct proportion to the decrease in the week of birth and birth&#xD;
        weight. While ROP is a problem below 32 weeks of gestation in developed countries, it is&#xD;
        reported to develop severely up to 34 weeks of gestation in developing countries. In a&#xD;
        multicenter study conducted by the Turkish Neonatology Society in our country, the frequency&#xD;
        of ROP in very low birth weight preterm infants was found to be 42%, and the frequency of&#xD;
        advanced ROP was 11%. The incidence of ROP in babies with a gestational age of 33-35 weeks&#xD;
        was 6.1%, and advanced ROP was 6 per thousand. The frequency of ROP was found to be 10.3% in&#xD;
        babies with a birth weight of 1500-2000 grams, and severe ROP was reported in 19 of these&#xD;
        babies. Thanks to the increasing frequency of preterm birth in recent years and scientific&#xD;
        and technological advances in neonatology, life expectancy is extended up to the 23rd week of&#xD;
        gestation. However, this increased the incidence of retinopathy. Therefore, it is of great&#xD;
        importance for neotologists, pediatricians and nurses who care for preterms to know the&#xD;
        pathophysiology, staging, risk factors and principles of appropriate care for them in&#xD;
        reducing the incidence, possible complications and mortality rates of ROP. ROP examination is&#xD;
        a procedure that causes pain, deterioration in comfort and physiological changes in preterm&#xD;
        newborns. After this examination, an increase in blood pressure and heart rate and a decrease&#xD;
        in oxygen saturation are observed. These physiological changes observed after the examination&#xD;
        continue for 24 hours. Pharmacological and non-pharmacological (non-pharmacological) methods&#xD;
        are used to reduce the pain and increase the comfort level of the premature newborn. As a&#xD;
        pharmacological method, there is no other routine method used to reduce pain other than the&#xD;
        administration of local anesthetic drops before the examination. Because of this situation,&#xD;
        nurses apply various non-pharmacological methods to alleviate pain. These methods are; breast&#xD;
        milk, sucrose use, oral dextrose use, non-nutritive sucking, positioning, listening to music&#xD;
        and mother's voice. In the literature review; In a study evaluating the effectiveness of&#xD;
        sucrose combination with non-nutritive sucking, they reported that pain was moderately&#xD;
        reduced and more studies are needed. In another study (2015), it was concluded that topical&#xD;
        anesthesia and oral dextrose were not effective in reducing pain in both groups. In a study&#xD;
        comparing the effectiveness of breast milk and sucrose, it is recommended to use breast milk&#xD;
        because of the rapid recovery of the baby after the ROP examination. In the comparison of the&#xD;
        position, which is another non-pharmacological method, with the routine practice in the study&#xD;
        conducted in 2019; It has been concluded that the frock position is more effective in&#xD;
        relieving pain. In another study, it was stated that the mother's voice as music therapy also&#xD;
        showed an analgesic effect and accelerated the recovery after the ROP examination. In the&#xD;
        light of this information, when we look at the literature, no specific study was found in&#xD;
        which a rain stick and The Happiest Baby music were used to reduce pain and increase the&#xD;
        comfort level during the ROP examination. Therefore, this research will be carried out to&#xD;
        determine the effect of different music played on the pain and comfort level of premature&#xD;
        babies during the retinopathy examination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The research is a stratified randomized controlled experimental type study.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Behavioral responses and physiological measurements of premature babies will be evaluated by using these video recordings by the nurse responsible for ROP, a lecturer who specializes in newborns and pain, and the researcher (3 experts), who are experienced in the ROP examination who do not know the groups, and who waive all rights of the research.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Baby Information Form:</measure>
      <time_frame>It will be applied when babies first arrive.</time_frame>
      <description>This form consists of 6 questions including the baby's birth weight, birth week, current weight, corrected week, and delivery type.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Premature Infant Pain Profile (PIPP)</measure>
      <time_frame>Approximately 2 minutes of video will be recorded and measurement will be taken approximately in the first minute of the video and 2 minutes after the video.</time_frame>
      <description>Pain assessment of preterm infants was performed with Premature Infant Pain Profile. The scale, which was developed by Stevens et al. in 1996 for 28-36 weeks preterms, is a multidimensional measurement tool with 7 sub-title evaluation criteria in the evaluation of acute pain in preterms (Gibbins et al., 2014). Turkish validity and reliability for all term and preterms were made by Derebent in 2007 within the scope of his master's thesis (Derebent, 2007). All sub-headings are scored between 0,1,2,3. According to the Turkish validity and reliability study of the scale, the highest score obtained from the scale is 21; 0-6 points indicate mild pain, 7-12 points indicate moderate pain, and 13-21 points indicate severe pain.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Premature Baby Comfort Scale</measure>
      <time_frame>Approximately 2 minutes of video will be recorded and measurement will be taken approximately in the first minute of the video and 2 minutes after the video.</time_frame>
      <description>Ambuel et al. The comfort scale was developed by Monique et al. This scale was adapted to Turkish by Alemdar and Tüfekçi in 2015 by Alemdar and Tüfekçi. PBKO; It is a multidimensional scale used to evaluate behavioral and psychological comfort and pain. PBCS assesses 7 parameters such as Alertness, Calmness/Agitation, Respiratory Status (only with 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. Accordingly, 35 indicates the lowest comfort score and 7 the highest. A high score on the scale indicates a low level of comfort. If the total score obtained is ≥17, it is the cut-off value of the scale, the limit value for the infant's comfort level, and indicates the need for an intervention to reduce pain.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Retinopathy of Prematurity</condition>
    <condition>Newborn</condition>
    <arm_group>
      <arm_group_label>Experiment 1 (Rainstick)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group will start playing music 3 minutes before the start of the process. The examination begins with the insertion of the speculum into the eye. The duration of the examination depends on the visibility of the vascularity in the retina and the examination will end with the removal of the speculum from the eye. The rain bar will continue to play during the ROP inspection. The rain stick will be played 25cm away from the baby.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experiment 2 (Music-The Happiest Baby)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During the ROP examination, Dr. Harvery Karp's &quot;The Happiest Baby&quot;, which consists of only intrauterine sounds, is a group of babies who are listened to. The experimental group will start playing music 3 minutes before the start of the process. The examination begins with the insertion of the speculum into the eye. The duration of the examination depends on the visibility of the vascularity in the retina and the examination will end with the removal of the speculum from the eye. Music will continue to play during the ROP exam. The voice recorder that will play The Happiest Baby will be placed 25 cm away from the baby. In the study, the music volume will be set as 45-50 decibels.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>It is the group of infants who receive routine care during the ROP examination. In the control group, a routine ROP procedure will be performed without any music before, during and after the ROP examination.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Research processes;</intervention_name>
      <description>Before Inspection: information will be obtained and premature babies will be monitored by wearing a pulse oximeter device and their heart rate and oxygen saturation value will be recorded for control purposes. By making video recordings of each premature baby; PIPP pain score, PBIC comfort score, control oxygen saturation and peak heart rate values will be recorded 3 minutes before the ROP examination. Babies will be fed and changed at least half an hour before the examination.&#xD;
  Inspection Sequence: PIPP pain score, PBIC comfort score, control oxygen saturation and peak heart rate values will be recorded and evaluated from the video recording that continues with the start of the examination.&#xD;
  End of Inspection: Infants whose both eye examinations are completed and whose monitoring and video recording continue will be recorded and evaluated 3 minutes after the end of the examination, with PIPP pain score, PBIC comfort score, control oxygen saturation and heart rate values.</description>
      <arm_group_label>Experiment 1 (Rainstick)</arm_group_label>
      <arm_group_label>Experiment 2 (Music-The Happiest Baby)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Gestational age ≤34 weeks&#xD;
  &#xD;
                 -  Birth Weight ≤2000 grams&#xD;
  &#xD;
                 -  Preterm newborns with a corrected/postnatal age of 28-36 weeks at the time of&#xD;
                    examination&#xD;
  &#xD;
                 -  Having the baby's first ROP examination&#xD;
  &#xD;
                 -  Not giving sedative, opioid and anticonvulsant drugs before/during the&#xD;
                    examination&#xD;
  &#xD;
                 -  Parents do not have diagnosed mental or mental problems and agree to participate&#xD;
                    in the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of a condition that prevents pain assessment (intracranial hemorrhage,&#xD;
               neuromotor developmental retardation, etc.)&#xD;
  &#xD;
                 -  Oxygen requirement (nasal cannula, hood or incubator)&#xD;
  &#xD;
                 -  Having any congenital defect (eye, neurological) that may adversely affect the&#xD;
                    examination&#xD;
  &#xD;
                 -  Having a diagnosed hearing loss&#xD;
  &#xD;
                 -  Performing a different painful procedure at least one hour before the ROP&#xD;
  &#xD;
                 -  Being connected to a mechanical ventilator&#xD;
  &#xD;
                 -  Congenital hearing problems in family members&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>28 Weeks</minimum_age>
      <maximum_age>36 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Semra KÖSE</last_name>
      <role>Study Director</role>
      <affiliation>Necmettin Erbakan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Semra KÖSE, PhD, Asisstant Proffessor</last_name>
      <phone>05433682203</phone>
      <email>semraak_88@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gizem Kıvrak</last_name>
      <email>gizemynlc@gmail.conm</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Necmettin Erbakan University</name>
        <address>
          <city>Konya</city>
          <state>Meram</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Semra KÖSE, PhD, Assistant Proffessor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Bilgeç, G. H., &amp; Erol N. (2018). Epidemiology, Prevalence and Incidence in Retinopathy of Prematurity (Vol. 2, Issue 1). Chen, H. L., Chen, C. H., Wu, C. C., Huang, H. J., Wang, T. M., &amp; Hsu, C. C. (2009). The Influence of Neonatal Intensive Care Unit Design on Sound Level. Pediatrics and Neonatology, 50(6), 270-274. https://doi.org/10.1016/S1875-9572(09)60076-0 Cohen, J. (2013). Statistical power analysis for the behavioral sciences. Routledge. Corrigan, M. J., Keeler, J. R., Miller, H. D., ben Khallouq, B. A., &amp; Fowler, S. B. (2020). Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery. Journal of Perinatology, 40(12), 1780-1788. https://doi.org/10.1038/S41372-020-0719-9 Derebent, E. (2007). The Effect of Kangaroo Care on Reducing Pain During Invasive Procedures for Premature Babies. Dilli, D., Ilarslan, N. E. Ç., Kabataş, E. U., Zenciroǧlu, A., Şimşek, Y., &amp; Okumuş, N. (2014). Oral sucrose and non-nutritive sucking goes some way to reducing pain during retinopathy of prematurity eye examinations. Acta Paediatrica (Oslo, Norway: 1992), 103(2). https://doi.org/10.1111/APA.12454 Dolgun, G. (2019). The Use of Pulse Oximetry in Defining Critical Congenital Heart Diseases and the Role of Midwife-Nurse. Journal of Education and Research in Nursing. https://doi.org/10.5222/head.2019.134 Gibbins, S., Stevens, B. J., Yamada, J., Dionne, K., Campbell-Yeo, M., Lee, G., Caddell, K., Johnston, C., &amp; Taddio, A. (2014). Validation of the Premature Infant Pain Profile-Revised (PIPP-R). Early Human Development, 90(4), 189-193. https://doi.org/10.1016/J.EARLHUMDEV.2014.01.005 Koç, E., Yağmur, A., Prof, B., Özdek, S., &amp; Ovali, F. (2021). Turkish Neonatology Society Turkish Ophthalmology Society Turkey Retinopathy of Prematurity Guideline 2021 Update. Küçük Alemdar, D., &amp; Güdücü Tüfekci, F. (2015). The Reliability and Validity of the Premature Infant Comfort Scale's Turkish. Journal of Education and Research in Nursing. https://doi.org/10.5222/head.2015.142 Metres, O. (2014). Retinopathy of Prematurity from a Nursing Perspective. https://cms.galenos.com.tr/Uploads/Article_25271/European%20Archives%20of%20Medical%20Research-30-63-En.pdf Metreş, Ö., &amp; Yıldız, S. (2019). Pain Management with ROP Position in Turkish Preterm Infants During Eye Examinations: A Randomized Controlled Trial. Journal of Pediatric Nursing, 49, e81-e89. https://doi.org/10.1016/J.PEDN.2019.08.013 Nesargi, S. v, Nithyanandam, S., Rao, S., Nimbalkar, S., &amp; Bhat, S. (2015). Topical Anesthesia or Oral Dextrose for the Relief of Pain in Screening for Retinopathy of Prematurity: a Randomized Controlled Double-blinded Trial. https://doi.org/10.1093/tropej/fmu058 Parra, J., de Suremain, A., Berne Audeoud, F., Ego, A., &amp; Debillon, T. (2017). Sound levels in a neonatal intensive care unit significantly exceeded recommendations, especially inside incubators. Acta Paediatrica, International Journal of Paediatrics, 106(12), 1909-1914. https://doi.org/10.1111/apa.13906 Sancak, S., Topçuoğlu, S., Çelik, G., Günay, M., &amp; Karatekin, G. (2019). Frequency of Retinopathy of Prematurity and Evaluation of Risk Factors. Zeynep Kamil Medical Bulletin. https://doi.org/10.16948/zktipb.474762 Sun, X., Lemyre, B., Barrowman, N., &amp; O'Connor, M. (2010). Pain management during eye examinations for retinopathy of prematurity in preterm infants: A systematic review. In Acta Paediatrica, International Journal of Paediatrics (Vol. 99, Issue 3, pp. 329-334). https://doi.org/10.1111/j.1651-2227.2009.01612.x Şener Taplak, A., &amp; Erdem, E. (2017). A Comparison of Breast Milk and Sucrose in Reducing Neonatal Pain During Eye Exam for Retinopathy of Prematurity. Breastfeeding Medicine: The Official Journal of the Academy of Breastfeeding Medicine, 12(5), 305-310. https://doi.org/10.1089/BFM.2016.0122 Taplak, A. S., &amp; Erdem, E. (2018). Pain Management in Examination for Retinopathy of Prematurity. In Journal of Health Sciences) (Vol. 27, Issue 2).</citation>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
      <investigator_full_name>Semra Kose</investigator_full_name>
      <investigator_title>Asisstant Proffessor</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Nursing</keyword>
    <keyword>Comfort</keyword>
    <keyword>Music</keyword>
    <keyword>Prematurity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Retinal Diseases</mesh_term>
      <mesh_term>Retinopathy of Prematurity</mesh_term>
      <mesh_term>Premature Birth</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05967572
  org study id: NecmettinEUSKose
  nct id: NCT05967572
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Retinopathy of Prematurity (ROP); It is a disease of premature and low birth weight infants,
        characterized by incomplete vascularization of the retina, etiology and pathogenesis of which
        is unknown, and causes vision loss. There is an increase in the incidence and severity of ROP
        development in direct proportion to the decrease in birth week and birth weight. While ROP is
        a problem below 32 weeks of gestation in developed countries, it is reported to develop
        severely up to 34 weeks of gestation in developing countries. In a multicenter study
        conducted by the Turkish Neonatology Society in our country, the frequency of ROP in very low
        birth weight preterm infants was found to be 42%, and the frequency of advanced ROP was 11%.
        The incidence of ROP in babies with a gestational age of 33-35 weeks was 6.1%, and advanced
        ROP was 6 per thousand. The frequency of ROP was found to be 10.3% in babies with a birth
        weight of 1500-2000 grams, and severe ROP was reported in 19 of these babies. ROP examination
        is a procedure that causes pain, deterioration in comfort and physiological changes in
        preterm newborns. After this examination, an increase in blood pressure and heart rate and a
        decrease in oxygen saturation are observed. Pharmacological and non-pharmacological
        (non-pharmacological) methods are used to reduce the pain and increase the comfort level of
        the premature newborn. As a pharmacological method, there is no other routine method used to
        reduce pain other than the administration of local anesthetic drops before the examination.
        Because of this situation, nurses apply various non-pharmacological methods to alleviate
        pain. These methods are; breast milk, sucrose use, oral dextrose use, non-nutritive sucking,
        positioning, listening to music and mother's voice. In the literature, no specific study was
        found in which music was used to reduce pain and increase the comfort level during the ROP
        examination. Therefore, this research will be carried out to determine the effect of
        different music played on the pain and comfort level of premature babies during the
        retinopathy examination.
  Retinopathy of Prematurity (ROP); It is a disease characterized by incomplete vascularization
        of the retina seen in premature and low birth weight infants, the etiology and pathogenesis
        of which are unknown, causing vision loss. There is an increase in the incidence and severity
        of ROP development in direct proportion to the decrease in the week of birth and birth
        weight. While ROP is a problem below 32 weeks of gestation in developed countries, it is
        reported to develop severely up to 34 weeks of gestation in developing countries. In a
        multicenter study conducted by the Turkish Neonatology Society in our country, the frequency
        of ROP in very low birth weight preterm infants was found to be 42%, and the frequency of
        advanced ROP was 11%. The incidence of ROP in babies with a gestational age of 33-35 weeks
        was 6.1%, and advanced ROP was 6 per thousand. The frequency of ROP was found to be 10.3% in
        babies with a birth weight of 1500-2000 grams, and severe ROP was reported in 19 of these
        babies. Thanks to the increasing frequency of preterm birth in recent years and scientific
        and technological advances in neonatology, life expectancy is extended up to the 23rd week of
        gestation. However, this increased the incidence of retinopathy. Therefore, it is of great
        importance for neotologists, pediatricians and nurses who care for preterms to know the
        pathophysiology, staging, risk factors and principles of appropriate care for them in
        reducing the incidence, possible complications and mortality rates of ROP. ROP examination is
        a procedure that causes pain, deterioration in comfort and physiological changes in preterm
        newborns. After this examination, an increase in blood pressure and heart rate and a decrease
        in oxygen saturation are observed. These physiological changes observed after the examination
        continue for 24 hours. Pharmacological and non-pharmacological (non-pharmacological) methods
        are used to reduce the pain and increase the comfort level of the premature newborn. As a
        pharmacological method, there is no other routine method used to reduce pain other than the
        administration of local anesthetic drops before the examination. Because of this situation,
        nurses apply various non-pharmacological methods to alleviate pain. These methods are; breast
        milk, sucrose use, oral dextrose use, non-nutritive sucking, positioning, listening to music
        and mother's voice. In the literature review; In a study evaluating the effectiveness of
        sucrose combination with non-nutritive sucking, they reported that pain was moderately
        reduced and more studies are needed. In another study (2015), it was concluded that topical
        anesthesia and oral dextrose were not effective in reducing pain in both groups. In a study
        comparing the effectiveness of breast milk and sucrose, it is recommended to use breast milk
        because of the rapid recovery of the baby after the ROP examination. In the comparison of the
        position, which is another non-pharmacological method, with the routine practice in the study
        conducted in 2019; It has been concluded that the frock position is more effective in
        relieving pain. In another study, it was stated that the mother's voice as music therapy also
        showed an analgesic effect and accelerated the recovery after the ROP examination. In the
        light of this information, when we look at the literature, no specific study was found in
        which a rain stick and The Happiest Baby music were used to reduce pain and increase the
        comfort level during the ROP examination. Therefore, this research will be carried out to
        determine the effect of different music played on the pain and comfort level of premature
        babies during the retinopathy examination.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The research is a stratified randomized controlled experimental type study.
  primary purpose: Supportive Care
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  masking description: Behavioral responses and physiological measurements of premature babies will be evaluated by using these video recordings by the nurse responsible for ROP, a lecturer who specializes in newborns and pain, and the researcher (3 experts), who are experienced in the ROP examination who do not know the groups, and who waive all rights of the research.
  measure: Baby Information Form:
  time frame: It will be applied when babies first arrive.
  description: This form consists of 6 questions including the baby's birth weight, birth week, current weight, corrected week, and delivery type.
  measure: Premature Infant Pain Profile (PIPP)
  time frame: Approximately 2 minutes of video will be recorded and measurement will be taken approximately in the first minute of the video and 2 minutes after the video.
  description: Pain assessment of preterm infants was performed with Premature Infant Pain Profile. The scale, which was developed by Stevens et al. in 1996 for 28-36 weeks preterms, is a multidimensional measurement tool with 7 sub-title evaluation criteria in the evaluation of acute pain in preterms (Gibbins et al., 2014). Turkish validity and reliability for all term and preterms were made by Derebent in 2007 within the scope of his master's thesis (Derebent, 2007). All sub-headings are scored between 0,1,2,3. According to the Turkish validity and reliability study of the scale, the highest score obtained from the scale is 21; 0-6 points indicate mild pain, 7-12 points indicate moderate pain, and 13-21 points indicate severe pain.
  measure: Premature Baby Comfort Scale
  time frame: Approximately 2 minutes of video will be recorded and measurement will be taken approximately in the first minute of the video and 2 minutes after the video.
  description: Ambuel et al. The comfort scale was developed by Monique et al. This scale was adapted to Turkish by Alemdar and Tüfekçi in 2015 by Alemdar and Tüfekçi. PBKO; It is a multidimensional scale used to evaluate behavioral and psychological comfort and pain. PBCS assesses 7 parameters such as Alertness, Calmness/Agitation, Respiratory Status (only with 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. Accordingly, 35 indicates the lowest comfort score and 7 the highest. A high score on the scale indicates a low level of comfort. If the total score obtained is ≥17, it is the cut-off value of the scale, the limit value for the infant's comfort level, and indicates the need for an intervention to reduce pain.
  arm group label: Experiment 1 (Rainstick)
  arm group type: Experimental
  description: The experimental group will start playing music 3 minutes before the start of the process. The examination begins with the insertion of the speculum into the eye. The duration of the examination depends on the visibility of the vascularity in the retina and the examination will end with the removal of the speculum from the eye. The rain bar will continue to play during the ROP inspection. The rain stick will be played 25cm away from the baby.
  arm group label: Experiment 2 (Music-The Happiest Baby)
  arm group type: Experimental
  description: During the ROP examination, Dr. Harvery Karp's "The Happiest Baby", which consists of only intrauterine sounds, is a group of babies who are listened to. The experimental group will start playing music 3 minutes before the start of the process. The examination begins with the insertion of the speculum into the eye. The duration of the examination depends on the visibility of the vascularity in the retina and the examination will end with the removal of the speculum from the eye. Music will continue to play during the ROP exam. The voice recorder that will play The Happiest Baby will be placed 25 cm away from the baby. In the study, the music volume will be set as 45-50 decibels.
  arm group label: Control
  arm group type: No Intervention
  description: It is the group of infants who receive routine care during the ROP examination. In the control group, a routine ROP procedure will be performed without any music before, during and after the ROP examination.
  intervention type: Other
  intervention name: Research processes;
  description: Before Inspection: information will be obtained and premature babies will be monitored by wearing a pulse oximeter device and their heart rate and oxygen saturation value will be recorded for control purposes. By making video recordings of each premature baby; PIPP pain score, PBIC comfort score, control oxygen saturation and peak heart rate values will be recorded 3 minutes before the ROP examination. Babies will be fed and changed at least half an hour before the examination.
  Inspection Sequence: PIPP pain score, PBIC comfort score, control oxygen saturation and peak heart rate values will be recorded and evaluated from the video recording that continues with the start of the examination.
  End of Inspection: Infants whose both eye examinations are completed and whose monitoring and video recording continue will be recorded and evaluated 3 minutes after the end of the examination, with PIPP pain score, PBIC comfort score, control oxygen saturation and heart rate values.
  arm group label: Experiment 1 (Rainstick)
  arm group label: Experiment 2 (Music-The Happiest Baby)
  criteria: 
  gender: All
  minimum age: 28 Weeks
  maximum age: 36 Weeks
  healthy volunteers: No
  last name: Semra KÖSE
  role: Study Director
  affiliation: Necmettin Erbakan University
  last name: Semra KÖSE, PhD, Asisstant Proffessor
  phone: 05433682203
  email: semraak_88@hotmail.com
  last name: Gizem Kıvrak
  email: gizemynlc@gmail.conm
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Bilgeç, G. H., & Erol N. (2018). Epidemiology, Prevalence and Incidence in Retinopathy of Prematurity (Vol. 2, Issue 1). Chen, H. L., Chen, C. H., Wu, C. C., Huang, H. J., Wang, T. M., & Hsu, C. C. (2009). The Influence of Neonatal Intensive Care Unit Design on Sound Level. Pediatrics and Neonatology, 50(6), 270-274. https://doi.org/10.1016/S1875-9572(09)60076-0 Cohen, J. (2013). Statistical power analysis for the behavioral sciences. Routledge. Corrigan, M. J., Keeler, J. R., Miller, H. D., ben Khallouq, B. A., & Fowler, S. B. (2020). Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery. Journal of Perinatology, 40(12), 1780-1788. https://doi.org/10.1038/S41372-020-0719-9 Derebent, E. (2007). The Effect of Kangaroo Care on Reducing Pain During Invasive Procedures for Premature Babies. Dilli, D., Ilarslan, N. E. Ç., Kabataş, E. U., Zenciroǧlu, A., Şimşek, Y., & Okumuş, N. (2014). Oral sucrose and non-nutritive sucking goes some way to reducing pain during retinopathy of prematurity eye examinations. Acta Paediatrica (Oslo, Norway: 1992), 103(2). https://doi.org/10.1111/APA.12454 Dolgun, G. (2019). The Use of Pulse Oximetry in Defining Critical Congenital Heart Diseases and the Role of Midwife-Nurse. Journal of Education and Research in Nursing. https://doi.org/10.5222/head.2019.134 Gibbins, S., Stevens, B. J., Yamada, J., Dionne, K., Campbell-Yeo, M., Lee, G., Caddell, K., Johnston, C., & Taddio, A. (2014). Validation of the Premature Infant Pain Profile-Revised (PIPP-R). Early Human Development, 90(4), 189-193. https://doi.org/10.1016/J.EARLHUMDEV.2014.01.005 Koç, E., Yağmur, A., Prof, B., Özdek, S., & Ovali, F. (2021). Turkish Neonatology Society Turkish Ophthalmology Society Turkey Retinopathy of Prematurity Guideline 2021 Update. Küçük Alemdar, D., & Güdücü Tüfekci, F. (2015). The Reliability and Validity of the Premature Infant Comfort Scale's Turkish. Journal of Education and Research in Nursing. https://doi.org/10.5222/head.2015.142 Metres, O. (2014). Retinopathy of Prematurity from a Nursing Perspective. https://cms.galenos.com.tr/Uploads/Article_25271/European%20Archives%20of%20Medical%20Research-30-63-En.pdf Metreş, Ö., & Yıldız, S. (2019). Pain Management with ROP Position in Turkish Preterm Infants During Eye Examinations: A Randomized Controlled Trial. Journal of Pediatric Nursing, 49, e81-e89. https://doi.org/10.1016/J.PEDN.2019.08.013 Nesargi, S. v, Nithyanandam, S., Rao, S., Nimbalkar, S., & Bhat, S. (2015). Topical Anesthesia or Oral Dextrose for the Relief of Pain in Screening for Retinopathy of Prematurity: a Randomized Controlled Double-blinded Trial. https://doi.org/10.1093/tropej/fmu058 Parra, J., de Suremain, A., Berne Audeoud, F., Ego, A., & Debillon, T. (2017). Sound levels in a neonatal intensive care unit significantly exceeded recommendations, especially inside incubators. Acta Paediatrica, International Journal of Paediatrics, 106(12), 1909-1914. https://doi.org/10.1111/apa.13906 Sancak, S., Topçuoğlu, S., Çelik, G., Günay, M., & Karatekin, G. (2019). Frequency of Retinopathy of Prematurity and Evaluation of Risk Factors. Zeynep Kamil Medical Bulletin. https://doi.org/10.16948/zktipb.474762 Sun, X., Lemyre, B., Barrowman, N., & O'Connor, M. (2010). Pain management during eye examinations for retinopathy of prematurity in preterm infants: A systematic review. In Acta Paediatrica, International Journal of Paediatrics (Vol. 99, Issue 3, pp. 329-334). https://doi.org/10.1111/j.1651-2227.2009.01612.x Şener Taplak, A., & Erdem, E. (2017). A Comparison of Breast Milk and Sucrose in Reducing Neonatal Pain During Eye Exam for Retinopathy of Prematurity. Breastfeeding Medicine: The Official Journal of the Academy of Breastfeeding Medicine, 12(5), 305-310. https://doi.org/10.1089/BFM.2016.0122 Taplak, A. S., & Erdem, E. (2018). Pain Management in Examination for Retinopathy of Prematurity. In Journal of Health Sciences) (Vol. 27, Issue 2).
  responsible party type: Principal Investigator
  investigator affiliation: Necmettin Erbakan University
  investigator full name: Semra Kose
  investigator title: Asisstant Proffessor
  mesh term: Retinal Diseases
  mesh term: Retinopathy of Prematurity
  mesh term: Premature Birth
  sharing ipd: No