<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/NCT04457921</url>
  </required_header>
  <id_info>
    <org_study_id>2019/57</org_study_id>
    <nct_id>NCT04457921</nct_id>
  </id_info>
  <brief_title>Deep Tissue Massage on Pain and Comfort After Cesarean</brief_title>
  <official_title>Effects of Deep Tissue Massage on Pain and Comfort After Cesarean: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu 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 aim of this study to determine the effect of deep tissue massage applied to the back on&#xD;
      pain and comfort after cesarean section. Personal information form was used as data&#xD;
      collection form, Visual Analog Scala was used to assess pain, and Postpartum Comfort&#xD;
      Questionnaire was used to assess comfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Material and Method&#xD;
&#xD;
      This research was conducted between May 2019 and November 2019 in Inonu University Turgut&#xD;
      Ozal Medical Center Training and Research Hospital. When power analysis was performed, the&#xD;
      sample size was calculated to be at least 81 women for each group (81 experiments, 81&#xD;
      controls). Experimental group received deep tissue massage twice at 11st and 23rd hours after&#xD;
      cesarean section. Data collection form for experimental and control groups before the first&#xD;
      massage; Visual Analog Scala was applied four times before and after both massages. After the&#xD;
      second massage, both groups were re-administered. Descriptive statistics and independent&#xD;
      t-test were used for data analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2019</start_date>
  <completion_date type="Actual">December 17, 2019</completion_date>
  <primary_completion_date type="Actual">November 25, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain scores</measure>
    <time_frame>at 11st hours cesarean section</time_frame>
    <description>Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain scores</measure>
    <time_frame>at 23rd hours cesarean section</time_frame>
    <description>Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comfort scores</measure>
    <time_frame>at 23rd hours cesarean section</time_frame>
    <description>Postpartum Comfort Questionnaire: The highest score from the scale is 170, the lowest score is 34. The increase in the average score obtained from the scale indicates that the comfort level also increases.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Massage</condition>
  <condition>Comfort</condition>
  <condition>Midwifery</condition>
  <arm_group>
    <arm_group_label>Deep tissue massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>deep tissue massage applied group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>group without deep tissue massage</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>deep tissue massage</intervention_name>
    <description>Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section.</description>
    <arm_group_label>Deep tissue massage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pain severity is 45 mm or more according to the Visual Analogue Scale (VAS),&#xD;
&#xD;
          -  Having a single and healthy newborn,&#xD;
&#xD;
          -  Does not respond negatively to any attempt to touch like massage,&#xD;
&#xD;
          -  Women whose tissue integrity is complete and healthy in the area to be massaged were&#xD;
             included in the sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with cesarean section with general anesthesia,&#xD;
&#xD;
          -  Any problems diagnosed before birth and at birth (such as oligohydramnios,&#xD;
             preeclampsia, heart disease, diabetes, placenta previa)&#xD;
&#xD;
          -  Any complications related to the mother and baby in the postpartum period (bleeding,&#xD;
             hypertension, babies taken to the neonatal intensive care unit, etc.),&#xD;
&#xD;
          -  Those who received repeat doses other than routine narcotic analgesics (0.5 mg in the&#xD;
             first 30 minutes) were not included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ESRA GUNEY</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inonu University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inonu University</name>
      <address>
        <city>Malatya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/30102886/</url>
    <description>Reference link</description>
  </link>
  <results_reference>
    <citation>Simonelli MC, Doyle LT, Columbia M, Wells PD, Benson KV, Lee CS. Effects of Connective Tissue Massage on Pain in Primiparous Women After Cesarean Birth. J Obstet Gynecol Neonatal Nurs. 2018 Sep;47(5):591-601. doi: 10.1016/j.jogn.2018.07.006. Epub 2018 Aug 11.</citation>
    <PMID>30102886</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>ESRA GUNEY</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>research results will be shared.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>Mary Colleen Simonelli</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://pubmed.ncbi.nlm.nih.gov/30102886/</doc_url>
      <doc_comment>web site is provided</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04457921
org study id: 2019/57
nct id: NCT04457921
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study to determine the effect of deep tissue massage applied to the back on
      pain and comfort after cesarean section. Personal information form was used as data
      collection form, Visual Analog Scala was used to assess pain, and Postpartum Comfort
      Questionnaire was used to assess comfort.
Material and Method

      This research was conducted between May 2019 and November 2019 in Inonu University Turgut
      Ozal Medical Center Training and Research Hospital. When power analysis was performed, the
      sample size was calculated to be at least 81 women for each group (81 experiments, 81
      controls). Experimental group received deep tissue massage twice at 11st and 23rd hours after
      cesarean section. Data collection form for experimental and control groups before the first
      massage; Visual Analog Scala was applied four times before and after both massages. After the
      second massage, both groups were re-administered. Descriptive statistics and independent
      t-test were used for data analysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: pain scores
time frame: at 11st hours cesarean section
description: Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm
measure: pain scores
time frame: at 23rd hours cesarean section
description: Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm
measure: comfort scores
time frame: at 23rd hours cesarean section
description: Postpartum Comfort Questionnaire: The highest score from the scale is 170, the lowest score is 34. The increase in the average score obtained from the scale indicates that the comfort level also increases.
arm group label: Deep tissue massage
arm group type: Experimental
description: deep tissue massage applied group
arm group label: Standard of care
arm group type: No Intervention
description: group without deep tissue massage
intervention type: Other
intervention name: deep tissue massage
description: Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section.
arm group label: Deep tissue massage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ESRA GUNEY
role: Principal Investigator
affiliation: Inonu University
facility: 
country: Turkey
url: http://pubmed.ncbi.nlm.nih.gov/30102886/
description: Reference link
citation: Simonelli MC, Doyle LT, Columbia M, Wells PD, Benson KV, Lee CS. Effects of Connective Tissue Massage on Pain in Primiparous Women After Cesarean Birth. J Obstet Gynecol Neonatal Nurs. 2018 Sep;47(5):591-601. doi: 10.1016/j.jogn.2018.07.006. Epub 2018 Aug 11.
PMID: 30102886
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: ESRA GUNEY
investigator title: Principal Investigator
mesh term: Pain, Postoperative
sharing ipd: No
ipd description: research results will be shared.
study doc: 