<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/NCT04416230</url>
  </required_header>
  <id_info>
    <org_study_id>IRB11-00662</org_study_id>
    <nct_id>NCT04416230</nct_id>
  </id_info>
  <brief_title>Post-Op Massage in Infants With Congenital Heart Disease</brief_title>
  <official_title>The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State 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 primary aims of the proposed study are to pilot test the effectiveness of daily massage&#xD;
      on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The&#xD;
      secondary aim is to explore relationships among massage, pain scores, and other variables&#xD;
      potentially affecting pain scores, including parental anxiety, severity of cardiac defect,&#xD;
      and severity of pain.&#xD;
&#xD;
      Specific Aim 1: To compare effects of massage on infant pain and clinical outcomes between&#xD;
      two groups over time: infants receiving post-operative massage seven days post-operatively&#xD;
      and infants receiving a comparable time of restricted non-essential caregiving seven days&#xD;
      post-operatively.&#xD;
&#xD;
      Specific Aim 2: To compare pain scores and physiologic responses before and after&#xD;
      intervention in two groups: infants receiving post-operative massage and infants receiving a&#xD;
      comparable time of restricted non-essential caregiving.&#xD;
&#xD;
      Specific Aim 3: To examine potential moderators of pain response in the massage intervention&#xD;
      group before and after receiving massage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We used a two-group randomized clinical trial design with a sample of 60 infants with complex&#xD;
      congenital heart disease (CCHD) between 1 day and 12 months of age following their first&#xD;
      cardiothoracic surgery. Both groups received standard post-operative care. In addition, Group&#xD;
      1 received a daily 30-minute restricted non-essential direct caregiving time (Quiet Time),&#xD;
      and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive&#xD;
      days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain&#xD;
      Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR),&#xD;
      respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily&#xD;
      averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed&#xD;
      using descriptive statistics, generalized linear mixed models (GLMM) for repeated measures,&#xD;
      latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic&#xD;
      values were used as a time-varying covariate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2012</start_date>
  <completion_date type="Actual">May 30, 2014</completion_date>
  <primary_completion_date type="Actual">August 3, 2013</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 intervention consisted of a massage given by a licensed massage therapist on each of seven consecutive days beginning on the day of surgery (Day 1). The massage included 30 minutes of Swedish massage on the infant's accessible upper extremities, lower extremities, head, face, and back. Standard precautions were used, including proper hand hygiene and the use of gloves when needed for infection control.&#xD;
Infants randomized to the comparison group received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Research assistants scoring participant pain were blinded to group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain score</measure>
    <time_frame>Daily average for 7 days</time_frame>
    <description>FLACC score: behavioral observation of face, legs, activity, cry, consolability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in post-operative pain score with intervention</measure>
    <time_frame>Daily for 7 days</time_frame>
    <description>FLACC score: behavioral observation of face, legs, activity, cry, consolability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Daily average for 7 days</time_frame>
    <description>heart rate in beats per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>Daily average for 7 days</time_frame>
    <description>respiratory rate in breaths per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>Daily average for 7 days</time_frame>
    <description>oxygen saturation percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in heart rate with intervention</measure>
    <time_frame>Daily for 7 days</time_frame>
    <description>heart rate in beats per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in respiratory rate with intervention</measure>
    <time_frame>Daily for 7 days</time_frame>
    <description>respiratory rate in beats per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in oxygen saturation with intervention</measure>
    <time_frame>Daily for 7 days</time_frame>
    <description>oxygen saturation percentage</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quiet Time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>massage</intervention_name>
    <description>The massage included 30 minutes of gentle friction, kneading, stroking, and passive touch on the infant's accessible upper extremities, lower extremities, head, face, and back.</description>
    <arm_group_label>Massage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>quiet time</intervention_name>
    <description>During quiet time, the infant received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.</description>
    <arm_group_label>Quiet Time</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born with complex congenital heart disease requiring surgical intervention&#xD;
&#xD;
          -  less than 12 months old&#xD;
&#xD;
          -  undergoing first surgical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  on paralytics post-operatively&#xD;
&#xD;
          -  cardiorespiratory instability&#xD;
&#xD;
          -  on-going cardiac pacing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tondi M Harrison, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ohio State University and Nationwide Children's Hospital</affiliation>
  </overall_official>
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  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Tondi Harrison</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>congenital heart disease</keyword>
  <keyword>massage</keyword>
  <keyword>pediatric pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make individual participant data available.</ipd_description>
  </patient_data>
  <!-- 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/NCT04416230
org study id: IRB11-00662
nct id: NCT04416230
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aims of the proposed study are to pilot test the effectiveness of daily massage
      on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The
      secondary aim is to explore relationships among massage, pain scores, and other variables
      potentially affecting pain scores, including parental anxiety, severity of cardiac defect,
      and severity of pain.

      Specific Aim 1: To compare effects of massage on infant pain and clinical outcomes between
      two groups over time: infants receiving post-operative massage seven days post-operatively
      and infants receiving a comparable time of restricted non-essential caregiving seven days
      post-operatively.

      Specific Aim 2: To compare pain scores and physiologic responses before and after
      intervention in two groups: infants receiving post-operative massage and infants receiving a
      comparable time of restricted non-essential caregiving.

      Specific Aim 3: To examine potential moderators of pain response in the massage intervention
      group before and after receiving massage.
We used a two-group randomized clinical trial design with a sample of 60 infants with complex
      congenital heart disease (CCHD) between 1 day and 12 months of age following their first
      cardiothoracic surgery. Both groups received standard post-operative care. In addition, Group
      1 received a daily 30-minute restricted non-essential direct caregiving time (Quiet Time),
      and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive
      days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain
      Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR),
      respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily
      averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed
      using descriptive statistics, generalized linear mixed models (GLMM) for repeated measures,
      latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic
      values were used as a time-varying covariate.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The intervention consisted of a massage given by a licensed massage therapist on each of seven consecutive days beginning on the day of surgery (Day 1). The massage included 30 minutes of Swedish massage on the infant's accessible upper extremities, lower extremities, head, face, and back. Standard precautions were used, including proper hand hygiene and the use of gloves when needed for infection control.
Infants randomized to the comparison group received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
masking description: Research assistants scoring participant pain were blinded to group.
measure: Post-operative pain score
time frame: Daily average for 7 days
description: FLACC score: behavioral observation of face, legs, activity, cry, consolability
measure: Change in post-operative pain score with intervention
time frame: Daily for 7 days
description: FLACC score: behavioral observation of face, legs, activity, cry, consolability
measure: Heart rate
time frame: Daily average for 7 days
description: heart rate in beats per minute
measure: Respiratory rate
time frame: Daily average for 7 days
description: respiratory rate in breaths per minute
measure: Oxygen saturation
time frame: Daily average for 7 days
description: oxygen saturation percentage
measure: Change in heart rate with intervention
time frame: Daily for 7 days
description: heart rate in beats per minute
measure: Change in respiratory rate with intervention
time frame: Daily for 7 days
description: respiratory rate in beats per minute
measure: Change in oxygen saturation with intervention
time frame: Daily for 7 days
description: oxygen saturation percentage
arm group label: Massage
arm group type: Experimental
description: Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study.
arm group label: Quiet Time
arm group type: Active Comparator
description: Infants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted.
intervention type: Behavioral
intervention name: massage
description: The massage included 30 minutes of gentle friction, kneading, stroking, and passive touch on the infant's accessible upper extremities, lower extremities, head, face, and back.
arm group label: Massage
intervention type: Behavioral
intervention name: quiet time
description: During quiet time, the infant received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.
arm group label: Quiet Time
criteria: 
gender: All
minimum age: 1 Day
maximum age: 12 Months
healthy volunteers: No
last name: Tondi M Harrison, PhD, RN
role: Principal Investigator
affiliation: The Ohio State University and Nationwide Children's Hospital
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responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Tondi Harrison
investigator title: Principal Investigator
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No
ipd description: There is not a plan to make individual participant data available.