<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/NCT03796312</url>
  </required_header>
  <id_info>
    <org_study_id>455111</org_study_id>
    <nct_id>NCT03796312</nct_id>
  </id_info>
  <brief_title>The Effect of Tub vs Sponge Bathing on the Comfort of Premature Infants</brief_title>
  <acronym>ComfortNEO</acronym>
  <official_title>The Effect of Tub Bathing and Sponge Bathing on Neonatal Comfort and Physiological Parameters in Late Preterm Infants: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akdeniz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akdeniz University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The integumentary system protects the underlying body from the external environment, such as&#xD;
      shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a&#xD;
      considerable body of clinical evidence highlighting the importance of the stratum corneum and&#xD;
      its barrier functions, which are especially beneficial for newborns. Given the dramatic&#xD;
      transition from the aqueous womb to the dry terrestrial environment at birth, studies&#xD;
      describing adaptations made by the skin barrier within the first month of life assume greater&#xD;
      importance. The skin of the baby is morphologically and functionally different from the skin&#xD;
      of adults. Neonatal skin is thinner, more fragile, and drier than adult skin; it is difficult&#xD;
      to maintain fluid-electrolyte balance and temperature regulation. Notwithstanding, structure&#xD;
      and function of skin continues to improve during the first months and even years of life.&#xD;
      Special care procedures are nonetheless necessary to ensure healthy development, to protect&#xD;
      the skin from irritation and reddening, and to help the newborn feel well. Therefore, this&#xD;
      study, taking the form of a randomized controlled trial, aims to examine the effectiveness of&#xD;
      tub bathing and sponge bathing on the physiological parameters (heart rate, respiration rate,&#xD;
      oxygen saturation, body temperature) and comfort of late preterm infants. Increasing comfort&#xD;
      and physiological stabilization in premature infants during neonatal care improves their&#xD;
      neurophysiological development. Bathing procedures that support this development and will not&#xD;
      expose the newborn to stress should be preferred.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increasing comfort and physiological stabilization in premature infants during neonatal care&#xD;
      improves their neurophysiological development. Bathing procedures that support this improves&#xD;
      and will not expose the newborn to stress should be preferred.This study aimed to examine the&#xD;
      eﬀectiveness of tub bathing and sponge bathing methods on the comfort and physiological&#xD;
      parameters of late preterm infants. The study was conducted in the Neonatal Intensive Care&#xD;
      Unit of a university hospital in Turkey, between November 2015 and November 2016. Skin care&#xD;
      is routinely performed between 08.00 and 09.00 in the form of sponge bathing. This research&#xD;
      study sampled 120 stable, late preterm infants being cared for in the NICU. This sample was&#xD;
      deemed adequate based on a sample size calculation conducted in PS Power and Sample Size&#xD;
      Calculations (Version 3.0). Information concerning allocation was available only to the&#xD;
      principal investigator. Participants were assigned a sequential number that was placed in an&#xD;
      opaque, sealed envelope by the researcher who received the signed parental informed consent.&#xD;
      When the participant was scheduled to be bathing, the envelope was opened by the researcher&#xD;
      who then performed the test. The nurses could not be blinded to the allocation because of the&#xD;
      nature of the intervention. However, the outcome assessment of the participants was blinded.&#xD;
      Participats were randomly assigned to either sponge bathing or tub bathing groups. Bathing&#xD;
      was performed anywhere from 6 to 48 hours post-birth, based on individual participant needs.&#xD;
      Participants were subsequently placed in a preheated incubator, which varied according to the&#xD;
      participant's weight and age. In order to compensate for such differences, the heads of all&#xD;
      participants were placed at a height of 30 degrees in a right lateral position after bathing&#xD;
      and they were monitored. The participants were not dressed during the observation period.&#xD;
      After bathing, participants were left without intervention or contact for approximately 10&#xD;
      minutes or until settled before being assessed. The data collection instrument, the Preterm&#xD;
      Infant Bathing Study Record, was designed specifically for this study. The instrument&#xD;
      incorporates a number of scales for the measurement of outcome variables, physiological&#xD;
      parameters, and demographic information (age, gender, type of delivery, gestational age,&#xD;
      birth weight, body weight at study time, etc.). Outcome measures include neonatal comfort&#xD;
      behavior and physiological parameters (body temperature, heart rate, oxygen saturation,&#xD;
      respiratory rate). Those responsible for data collection were blinded as to the allocation of&#xD;
      participants they were assessing. The ComfortNeo scale was used to measure newborns' comfort&#xD;
      and pain intensity. Comfort was inferred based on infant behavior, which was evaluated on two&#xD;
      separate occasions, 10 minutes before bathing and 10 minutes after bathing. Measurement took&#xD;
      approximately 1-2 minutes. Internal consistency was measured by way of Cronbach's alpha&#xD;
      coefficient, which was 0.94 before bathing, 0.93 after bathing for the second researcher, and&#xD;
      0.92 after bathing for the nurse. Kappa coefficients were approximately 0.84 for each&#xD;
      sub-item. Thus, there was harmony between the two observers. Infant physiological parameters&#xD;
      (heart rate, respiratory rate, oxygen saturation, and body temperature) were evaluated on&#xD;
      three separate occasions (10 minutes before bathing, 15 minutes and 30 minutes after&#xD;
      bathing).Statistical analysis was performed using SPSS 20.0 and SAS (ver.9.3), with&#xD;
      statistical signiﬁcance set at p&lt;0.05.&#xD;
&#xD;
      Data was presented as means and standard deviations for continuous variables, and frequencies&#xD;
      for categorical variables. For participant characteristics, such as the type of delivery and&#xD;
      sex, a Chi-square test was applied to determine whether there were signiﬁcant between-group&#xD;
      differences. participant characteristics, such as birth weight and body weight at the time of&#xD;
      the study, were evaluated for signiﬁcant between-group diﬀerences using a one way ANOVA test.&#xD;
      For a comparison of the diﬀerent phases, measurement parameters (comfort score, heart rate,&#xD;
      oxygen saturation, respiratory rate, body temperature) through the baths were averaged&#xD;
      separately. Repeated measurement analysis of variance was performed to analyze both between&#xD;
      and within-group diﬀerences, followed by the Bonferroni post-hoc test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2015</start_date>
  <completion_date type="Actual">November 29, 2016</completion_date>
  <primary_completion_date type="Actual">November 29, 2016</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>A randomized controlled two-group pre-test and repeated post-test study design were adopted. Preterm infants were randomly allocated before bathing by the researcher using a random computer-generated table to one of two groups: sponge bathing (routine care) or tub bathing. The bathing procedures were performed by the researcher. Nurses and a second researcher were blinded to the study hypotheses.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Physiological data was collected by nurses trained by the lead researcher. Data on neonatal comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal Comfort</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>Data on comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing. The ComfortNeo scale was used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting. Comfort was inferred based on infant behavior 10 minutes before bathing and 10 minutes after bathing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants. Pulse oximetry measures peripheral arterial oxygen saturation (%) as a surrogate marker for tissue oxygenation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiration Rate</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Temperature</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>Body temperature was measured using the axillary method (under the armpit)in degrees Celsius.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Preterm Infant</condition>
  <condition>Premature Birth</condition>
  <arm_group>
    <arm_group_label>Tub Bathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, preterm infants were given tub bathing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sponge Bathing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Separate cotton cloths were prepared for each body area in the sponge bath. The room temperature was set to 26-27°C to prevent hypothermia. The temperature of the water used for sponge bathing was set to 37-38°C. Alongside the bath, the infant was placed on a flat, protected surface and washed from a bowl of water, using the same mild cleanser. The eyes, face, and head were wiped and dried while the baby was wrapped in a blanket. The wrap was opened so that body parts could be washed, dried, and then immediately rewrapped, after which infants were diapered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tub Bathing</intervention_name>
    <description>The infant's face was washed and dried while still wrapped before being immersed. The water level in the tub was set at approximately 9-12 cm or deep enough to cover the baby's shoulders. A folded cloth towel was placed into the tub before bathing. The temperature of the bath water was controlled using a special water thermometer and adjusted to 37-38°C. The infant was held securely; the head and neck were supported on the researcher's forearm, and the shoulder was grasped using the researcher's thumb and finger. Cleaning was performed using a soft cloth and baby skin cleaner. The front and back areas were cleaned without turning the infant. The newborn was safely removed from the water and wrapped in a clean towel.</description>
    <arm_group_label>Tub Bathing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sponge Bathing</intervention_name>
    <description>Sponge bathing is routine care of the clinic</description>
    <arm_group_label>Sponge Bathing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All inborn infants with a gestational age of 34 weeks and 0 days to 36 weeks and 6&#xD;
             days (late preterm) were eligible to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants were excluded from the study if they were connected to&#xD;
&#xD;
          -  a mechanical ventilator,&#xD;
&#xD;
          -  if they had bathed in the last 12 hours,&#xD;
&#xD;
          -  if within the first 78 hours of the postoperative period,&#xD;
&#xD;
          -  had a central catheter,&#xD;
&#xD;
          -  had received either a sedative and/or muscle relaxant,&#xD;
&#xD;
          -  if they did not fulﬁll the inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>34 Weeks</minimum_age>
    <maximum_age>36 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emine EFE</last_name>
    <role>Study Director</role>
    <affiliation>Akdeniz University Children's Health and the Nursing Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akdeniz Universty</name>
      <address>
        <city>Antalya</city>
        <zip>07000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.</citation>
    <PMID>15561658</PMID>
  </reference>
  <reference>
    <citation>Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.</citation>
    <PMID>22375955</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 5, 2019</last_update_submitted>
  <last_update_submitted_qc>January 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Akdeniz University</investigator_affiliation>
    <investigator_full_name>Halil Ibrahim Tasdemir</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Bathing</keyword>
  <keyword>Comfort</keyword>
  <keyword>Neonatal intensive care unit</keyword>
  <keyword>Nursing care</keyword>
  <keyword>Premature infant</keyword>
  <keyword>Skin care</keyword>
  <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>
    <ipd_description>The data sharing plans for the current study are unknown and will be made available at a later date</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>March 29, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03796312
org study id: 455111
nct id: NCT03796312
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The integumentary system protects the underlying body from the external environment, such as
      shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a
      considerable body of clinical evidence highlighting the importance of the stratum corneum and
      its barrier functions, which are especially beneficial for newborns. Given the dramatic
      transition from the aqueous womb to the dry terrestrial environment at birth, studies
      describing adaptations made by the skin barrier within the first month of life assume greater
      importance. The skin of the baby is morphologically and functionally different from the skin
      of adults. Neonatal skin is thinner, more fragile, and drier than adult skin; it is difficult
      to maintain fluid-electrolyte balance and temperature regulation. Notwithstanding, structure
      and function of skin continues to improve during the first months and even years of life.
      Special care procedures are nonetheless necessary to ensure healthy development, to protect
      the skin from irritation and reddening, and to help the newborn feel well. Therefore, this
      study, taking the form of a randomized controlled trial, aims to examine the effectiveness of
      tub bathing and sponge bathing on the physiological parameters (heart rate, respiration rate,
      oxygen saturation, body temperature) and comfort of late preterm infants. Increasing comfort
      and physiological stabilization in premature infants during neonatal care improves their
      neurophysiological development. Bathing procedures that support this development and will not
      expose the newborn to stress should be preferred.
Increasing comfort and physiological stabilization in premature infants during neonatal care
      improves their neurophysiological development. Bathing procedures that support this improves
      and will not expose the newborn to stress should be preferred.This study aimed to examine the
      eﬀectiveness of tub bathing and sponge bathing methods on the comfort and physiological
      parameters of late preterm infants. The study was conducted in the Neonatal Intensive Care
      Unit of a university hospital in Turkey, between November 2015 and November 2016. Skin care
      is routinely performed between 08.00 and 09.00 in the form of sponge bathing. This research
      study sampled 120 stable, late preterm infants being cared for in the NICU. This sample was
      deemed adequate based on a sample size calculation conducted in PS Power and Sample Size
      Calculations (Version 3.0). Information concerning allocation was available only to the
      principal investigator. Participants were assigned a sequential number that was placed in an
      opaque, sealed envelope by the researcher who received the signed parental informed consent.
      When the participant was scheduled to be bathing, the envelope was opened by the researcher
      who then performed the test. The nurses could not be blinded to the allocation because of the
      nature of the intervention. However, the outcome assessment of the participants was blinded.
      Participats were randomly assigned to either sponge bathing or tub bathing groups. Bathing
      was performed anywhere from 6 to 48 hours post-birth, based on individual participant needs.
      Participants were subsequently placed in a preheated incubator, which varied according to the
      participant's weight and age. In order to compensate for such differences, the heads of all
      participants were placed at a height of 30 degrees in a right lateral position after bathing
      and they were monitored. The participants were not dressed during the observation period.
      After bathing, participants were left without intervention or contact for approximately 10
      minutes or until settled before being assessed. The data collection instrument, the Preterm
      Infant Bathing Study Record, was designed specifically for this study. The instrument
      incorporates a number of scales for the measurement of outcome variables, physiological
      parameters, and demographic information (age, gender, type of delivery, gestational age,
      birth weight, body weight at study time, etc.). Outcome measures include neonatal comfort
      behavior and physiological parameters (body temperature, heart rate, oxygen saturation,
      respiratory rate). Those responsible for data collection were blinded as to the allocation of
      participants they were assessing. The ComfortNeo scale was used to measure newborns' comfort
      and pain intensity. Comfort was inferred based on infant behavior, which was evaluated on two
      separate occasions, 10 minutes before bathing and 10 minutes after bathing. Measurement took
      approximately 1-2 minutes. Internal consistency was measured by way of Cronbach's alpha
      coefficient, which was 0.94 before bathing, 0.93 after bathing for the second researcher, and
      0.92 after bathing for the nurse. Kappa coefficients were approximately 0.84 for each
      sub-item. Thus, there was harmony between the two observers. Infant physiological parameters
      (heart rate, respiratory rate, oxygen saturation, and body temperature) were evaluated on
      three separate occasions (10 minutes before bathing, 15 minutes and 30 minutes after
      bathing).Statistical analysis was performed using SPSS 20.0 and SAS (ver.9.3), with
      statistical signiﬁcance set at p<0.05.

      Data was presented as means and standard deviations for continuous variables, and frequencies
      for categorical variables. For participant characteristics, such as the type of delivery and
      sex, a Chi-square test was applied to determine whether there were signiﬁcant between-group
      differences. participant characteristics, such as birth weight and body weight at the time of
      the study, were evaluated for signiﬁcant between-group diﬀerences using a one way ANOVA test.
      For a comparison of the diﬀerent phases, measurement parameters (comfort score, heart rate,
      oxygen saturation, respiratory rate, body temperature) through the baths were averaged
      separately. Repeated measurement analysis of variance was performed to analyze both between
      and within-group diﬀerences, followed by the Bonferroni post-hoc test.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled two-group pre-test and repeated post-test study design were adopted. Preterm infants were randomly allocated before bathing by the researcher using a random computer-generated table to one of two groups: sponge bathing (routine care) or tub bathing. The bathing procedures were performed by the researcher. Nurses and a second researcher were blinded to the study hypotheses.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Physiological data was collected by nurses trained by the lead researcher. Data on neonatal comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing.
measure: Neonatal Comfort
time frame: An average of 1 year
description: Data on comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing. The ComfortNeo scale was used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting. Comfort was inferred based on infant behavior 10 minutes before bathing and 10 minutes after bathing.
measure: Heart Rate
time frame: An average of 1 year
description: The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
measure: Oxygen Saturation
time frame: An average of 1 year
description: Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants. Pulse oximetry measures peripheral arterial oxygen saturation (%) as a surrogate marker for tissue oxygenation.
measure: Respiration Rate
time frame: An average of 1 year
description: The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises.
measure: Body Temperature
time frame: An average of 1 year
description: Body temperature was measured using the axillary method (under the armpit)in degrees Celsius.
arm group label: Tub Bathing
arm group type: Experimental
description: In this group, preterm infants were given tub bathing.
arm group label: Sponge Bathing
arm group type: Active Comparator
description: Separate cotton cloths were prepared for each body area in the sponge bath. The room temperature was set to 26-27°C to prevent hypothermia. The temperature of the water used for sponge bathing was set to 37-38°C. Alongside the bath, the infant was placed on a flat, protected surface and washed from a bowl of water, using the same mild cleanser. The eyes, face, and head were wiped and dried while the baby was wrapped in a blanket. The wrap was opened so that body parts could be washed, dried, and then immediately rewrapped, after which infants were diapered.
intervention type: Behavioral
intervention name: Tub Bathing
description: The infant's face was washed and dried while still wrapped before being immersed. The water level in the tub was set at approximately 9-12 cm or deep enough to cover the baby's shoulders. A folded cloth towel was placed into the tub before bathing. The temperature of the bath water was controlled using a special water thermometer and adjusted to 37-38°C. The infant was held securely; the head and neck were supported on the researcher's forearm, and the shoulder was grasped using the researcher's thumb and finger. Cleaning was performed using a soft cloth and baby skin cleaner. The front and back areas were cleaned without turning the infant. The newborn was safely removed from the water and wrapped in a clean towel.
arm group label: Tub Bathing
intervention type: Behavioral
intervention name: Sponge Bathing
description: Sponge bathing is routine care of the clinic
arm group label: Sponge Bathing
criteria: 
gender: All
minimum age: 34 Weeks
maximum age: 36 Weeks
healthy volunteers: No
last name: Emine EFE
role: Study Director
affiliation: Akdeniz University Children's Health and the Nursing Department
facility: 
country: Turkey
citation: Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.
PMID: 15561658
citation: Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.
PMID: 22375955
responsible party type: Principal Investigator
investigator affiliation: Akdeniz University
investigator full name: Halil Ibrahim Tasdemir
investigator title: Research Assistant
mesh term: Premature Birth
sharing ipd: No
ipd description: The data sharing plans for the current study are unknown and will be made available at a later date
submitted: March 29, 2023