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/NCT05978674</url>
    </required_header>
    <id_info>
      <org_study_id>SelcukUnı42Konya</org_study_id>
      <nct_id>NCT05978674</nct_id>
    </id_info>
    <brief_title>The Effect of Rocking Bed on Preterm Newborns</brief_title>
    <official_title>The Effect of Rocking Bed on Comfort, Physiological Parameters and Cerebral Oxygenation Level of Preterm Infants: a Near Infrared Spectroscopy Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Selcuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Selcuk University</source>
    <oversight_info>
      <has_dmc>No</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>
        The study was planned to determine the effect of rocking bed applied to preterm newborns on&#xD;
        comfort, physiological parameters and cerebral oxygenase level (rSO2).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In most cultures, providing a newborn baby on the lap or in a rocking bed is mostly used to&#xD;
        calm the baby. However, preterm babies who leave the uterus, which is their accustomed&#xD;
        environment, in the early period, are positioned on a fixed bed such as an incubator or jeans&#xD;
        in the NICU. These beds may reduce the infant's vestibular knowledge and the NICU environment&#xD;
        may deprive infants of sensory stimuli. It has been suggested that because the vestibular&#xD;
        system is one of the first systems to become functional, preterm infants may be more&#xD;
        sensitive to stimulation of the vestibular system than other systems. When the studies were&#xD;
        examined, it was seen that limited studies were conducted in the sample of preterm infants&#xD;
        and the studies were not recent. Considering that babies are rocked in most cultures, it is&#xD;
        thought that the evidence for the effects of the intervention on the baby is insufficient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 15, 2021</start_date>
    <completion_date type="Actual">September 15, 2022</completion_date>
    <primary_completion_date type="Actual">September 15, 2022</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>Crossover Assignment</intervention_model>
      <intervention_model_description>The study was planned to be conducted in a randomized controlled crossover design. Infants meeting the inclusion criteria will be divided into two groups, group A and group B, according to block randomization. Groups were determined by drawing lots. (A= Rocking bed; B= Jeans) Accordingly, babies included in group A will be taken to the rocking bed first. Babies included in group B will be quoted first. Babies will be laid in these beds for an average of 2 hours. In cross-over design, a washout is recommended in order to control the carry over effect that may result from the interference. We assumed that the total time without interference would be sufficient to control the carryover effect, since the oscillation interference was only applied for half an hour in a two-hour sleep cycle, and there was routine maintenance and feeding cycles between measurements (average 20 min).</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Information Form</measure>
      <time_frame>First measurement- At 15 minutes after admission in the study</time_frame>
      <description>In the form prepared by the researchers in line with the literature in order to collect introductory information about the baby; There are questions for the baby such as gender, mode of delivery, weight at birth, Apgar score (1st and 5th value), gestational age at birth, postnatal age, weight in the study, diet, type of food, frequency of vomiting (O'Reilly et al., 2011; Provasi et al., 2021; Zimmerman &amp; Barlow, 2012). For the final version of the form, opinions were received from 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>COMFORT Scale</measure>
      <time_frame>First measurement: T0: just before the intervention</time_frame>
      <description>The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, &quot;respiratory response&quot; is scored, and if the newborn is breathing spontaneously, &quot;crying&quot; items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, &amp; Yalaz, 2014).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Newborn Follow-up Form</measure>
      <time_frame>First measurement: T0: just before the intervention</time_frame>
      <description>This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman &amp; Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>COMFORT Scale</measure>
      <time_frame>Second measurement: T1: 15th minute of the intervention</time_frame>
      <description>The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, &quot;respiratory response&quot; is scored, and if the newborn is breathing spontaneously, &quot;crying&quot; items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, &amp; Yalaz, 2014).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Newborn Follow-up Form</measure>
      <time_frame>Second measurement: T1: 15th minute of the intervention</time_frame>
      <description>This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman &amp; Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COMFORT Scale</measure>
      <time_frame>Third measurement: T2: 30th minute of the intervention</time_frame>
      <description>The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, &quot;respiratory response&quot; is scored, and if the newborn is breathing spontaneously, &quot;crying&quot; items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, &amp; Yalaz, 2014).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Newborn Follow-up Form</measure>
      <time_frame>Third measurement: T2: 30th minute of the intervention</time_frame>
      <description>This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman &amp; Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COMFORT Scale</measure>
      <time_frame>Fourth measurement: T3: 15 minutes after the end of the intervention</time_frame>
      <description>The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, &quot;respiratory response&quot; is scored, and if the newborn is breathing spontaneously, &quot;crying&quot; items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, &amp; Yalaz, 2014).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Newborn Follow-up Form</measure>
      <time_frame>Fourth measurement: T3: 15 minutes after the end of the intervention</time_frame>
      <description>This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman &amp; Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">36</enrollment>
    <condition>Preterm</condition>
    <condition>Preterm Birth</condition>
    <condition>Nurse's Role</condition>
    <arm_group>
      <arm_group_label>Experimental Group: rocking bed group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Preterms in the intervention group will lie in a rocking bed for a consecutive two-hour period without treatment and invasive procedures. During 30 minutes of this period, the rocking bed will be in the rocking mode and will stop at the end of 30 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Newborns in the control group will be followed in a fixed bed (open bed or incubator).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>rocking bed group</intervention_name>
      <description>Babies assigned to the intervention group first will be placed on a rocking bed after routine care such as feeding and diaper changes and when the newborn is stable. A rocking attempt will be applied to the baby placed in the rocking bed for 30 minutes. After 30 minutes, the baby will not be lifted from the bed and will lie in bed for 90 minutes. After a period of two hours in total, the babies will be cared for and fed. Then, babies will be quota and control group measurements will be made.</description>
      <arm_group_label>Experimental Group: rocking bed group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Born at 32-37 weeks of postmenstruel age&#xD;
  &#xD;
            -  Not receiving mechanical ventilation support,&#xD;
  &#xD;
            -  Not receiving analgesia or sedative drug therapy,&#xD;
  &#xD;
            -  Congenital anomaly, intraventricular hemorrhage, meningitis, chromosomal anomalies,&#xD;
               cyanotic congenital heart diseases, neonatal seizures and preterm infants without a&#xD;
               diagnosis of sepsis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Infants with diseases that may decrease cerebral oxygenation such as cerebral edema,&#xD;
          intraventricular hemorrhage, cerebral hypoxia will be excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>32 Weeks</minimum_age>
      <maximum_age>37 Weeks</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sibel Küçükoğlu, Prof</last_name>
      <role>Study Director</role>
      <affiliation>Selcuk University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Selcuk University</name>
        <address>
          <city>Konya</city>
          <state>Selcuklu</state>
          <zip>42100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95.</citation>
      <PMID>1545324</PMID>
    </reference>
    <reference>
      <citation>Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.</citation>
      <PMID>27777223</PMID>
    </reference>
    <reference>
      <citation>O'Reilly R, Grindle C, Zwicky EF, Morlet T. Development of the vestibular system and balance function: differential diagnosis in the pediatric population. Otolaryngol Clin North Am. 2011 Apr;44(2):251-71, vii. doi: 10.1016/j.otc.2011.01.001.</citation>
      <PMID>21474003</PMID>
    </reference>
    <reference>
      <citation>Provasi J, Blanc L, Carchon I. The Importance of Rhythmic Stimulation for Preterm Infants in the NICU. Children (Basel). 2021 Jul 29;8(8):660. doi: 10.3390/children8080660.</citation>
      <PMID>34438551</PMID>
    </reference>
    <reference>
      <citation>van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.</citation>
      <PMID>19692803</PMID>
    </reference>
    <reference>
      <citation>Zimmerman E, Barlow SM. The effects of vestibular stimulation rate and magnitude of acceleration on central pattern generation for chest wall kinematics in preterm infants. J Perinatol. 2012 Aug;32(8):614-20. doi: 10.1038/jp.2011.177. Epub 2011 Dec 8.</citation>
      <PMID>22157627</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Selcuk University</investigator_affiliation>
      <investigator_full_name>Sibel Küçükoğlu</investigator_full_name>
      <investigator_title>Faculty of Nursing</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT05978674
  org study id: SelcukUnı42Konya
  nct id: NCT05978674
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study was planned to determine the effect of rocking bed applied to preterm newborns on
        comfort, physiological parameters and cerebral oxygenase level (rSO2).
  In most cultures, providing a newborn baby on the lap or in a rocking bed is mostly used to
        calm the baby. However, preterm babies who leave the uterus, which is their accustomed
        environment, in the early period, are positioned on a fixed bed such as an incubator or jeans
        in the NICU. These beds may reduce the infant's vestibular knowledge and the NICU environment
        may deprive infants of sensory stimuli. It has been suggested that because the vestibular
        system is one of the first systems to become functional, preterm infants may be more
        sensitive to stimulation of the vestibular system than other systems. When the studies were
        examined, it was seen that limited studies were conducted in the sample of preterm infants
        and the studies were not recent. Considering that babies are rocked in most cultures, it is
        thought that the evidence for the effects of the intervention on the baby is insufficient.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: The study was planned to be conducted in a randomized controlled crossover design. Infants meeting the inclusion criteria will be divided into two groups, group A and group B, according to block randomization. Groups were determined by drawing lots. (A= Rocking bed; B= Jeans) Accordingly, babies included in group A will be taken to the rocking bed first. Babies included in group B will be quoted first. Babies will be laid in these beds for an average of 2 hours. In cross-over design, a washout is recommended in order to control the carry over effect that may result from the interference. We assumed that the total time without interference would be sufficient to control the carryover effect, since the oscillation interference was only applied for half an hour in a two-hour sleep cycle, and there was routine maintenance and feeding cycles between measurements (average 20 min).
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Information Form
  time frame: First measurement- At 15 minutes after admission in the study
  description: In the form prepared by the researchers in line with the literature in order to collect introductory information about the baby; There are questions for the baby such as gender, mode of delivery, weight at birth, Apgar score (1st and 5th value), gestational age at birth, postnatal age, weight in the study, diet, type of food, frequency of vomiting (O'Reilly et al., 2011; Provasi et al., 2021; Zimmerman & Barlow, 2012). For the final version of the form, opinions were received from 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing.
  measure: COMFORT Scale
  time frame: First measurement: T0: just before the intervention
  description: The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).
  measure: Newborn Follow-up Form
  time frame: First measurement: T0: just before the intervention
  description: This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.
  measure: COMFORT Scale
  time frame: Second measurement: T1: 15th minute of the intervention
  description: The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).
  measure: Newborn Follow-up Form
  time frame: Second measurement: T1: 15th minute of the intervention
  description: This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.
  measure: COMFORT Scale
  time frame: Third measurement: T2: 30th minute of the intervention
  description: The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).
  measure: Newborn Follow-up Form
  time frame: Third measurement: T2: 30th minute of the intervention
  description: This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.
  measure: COMFORT Scale
  time frame: Fourth measurement: T3: 15 minutes after the end of the intervention
  description: The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).
  measure: Newborn Follow-up Form
  time frame: Fourth measurement: T3: 15 minutes after the end of the intervention
  description: This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.
  arm group label: Experimental Group: rocking bed group
  arm group type: Experimental
  description: Preterms in the intervention group will lie in a rocking bed for a consecutive two-hour period without treatment and invasive procedures. During 30 minutes of this period, the rocking bed will be in the rocking mode and will stop at the end of 30 minutes.
  arm group label: Control Group
  arm group type: No Intervention
  description: Newborns in the control group will be followed in a fixed bed (open bed or incubator).
  intervention type: Behavioral
  intervention name: rocking bed group
  description: Babies assigned to the intervention group first will be placed on a rocking bed after routine care such as feeding and diaper changes and when the newborn is stable. A rocking attempt will be applied to the baby placed in the rocking bed for 30 minutes. After 30 minutes, the baby will not be lifted from the bed and will lie in bed for 90 minutes. After a period of two hours in total, the babies will be cared for and fed. Then, babies will be quota and control group measurements will be made.
  arm group label: Experimental Group: rocking bed group
  criteria: 
  gender: All
  minimum age: 32 Weeks
  maximum age: 37 Weeks
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sibel Küçükoğlu, Prof
  role: Study Director
  affiliation: Selcuk University
  facility: 
  country: Turkey
  citation: Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95.
  PMID: 1545324
  citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
  PMID: 27777223
  citation: O'Reilly R, Grindle C, Zwicky EF, Morlet T. Development of the vestibular system and balance function: differential diagnosis in the pediatric population. Otolaryngol Clin North Am. 2011 Apr;44(2):251-71, vii. doi: 10.1016/j.otc.2011.01.001.
  PMID: 21474003
  citation: Provasi J, Blanc L, Carchon I. The Importance of Rhythmic Stimulation for Preterm Infants in the NICU. Children (Basel). 2021 Jul 29;8(8):660. doi: 10.3390/children8080660.
  PMID: 34438551
  citation: van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
  PMID: 19692803
  citation: Zimmerman E, Barlow SM. The effects of vestibular stimulation rate and magnitude of acceleration on central pattern generation for chest wall kinematics in preterm infants. J Perinatol. 2012 Aug;32(8):614-20. doi: 10.1038/jp.2011.177. Epub 2011 Dec 8.
  PMID: 22157627
  responsible party type: Principal Investigator
  investigator affiliation: Selcuk University
  investigator full name: Sibel Küçükoğlu
  investigator title: Faculty of Nursing
  mesh term: Premature Birth
  sharing ipd: No