<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/NCT03792230</url>
  </required_header>
  <id_info>
    <org_study_id>ozgubakcek</org_study_id>
    <nct_id>NCT03792230</nct_id>
  </id_info>
  <brief_title>Comparison Of The Effects Of Different Body Mechanics Education</brief_title>
  <official_title>Comparison Of The Effects Of Different Body Mechanics Education Methods On Pain, Disability And Quality Of Life: Randomised Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluated the comparison of the different patient education methods. The study&#xD;
      involved two stages of data collection: one during the preoperative period, the other during&#xD;
      the sixth postoperative week.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before commencing the study, we informed participants who met the inclusion criteria about&#xD;
      the scope of the study and obtained their written and oral consent. Participants in each&#xD;
      group completed the data collection form regarding patients' characteristics, the SF-MPQ, the&#xD;
      ODI and the Physical Functioning and Bodily Pain subscales of the SF-36. A day before LDH&#xD;
      (Lumbar Disc Hernia) surgery, participants in the control group received standard clinical&#xD;
      education, whereas ones in the intervention groups received either video- or brochure-based&#xD;
      education. Participants in the brochure group learned about the proper use of body mechanics&#xD;
      from the &quot;Body Mechanics Educational Brochure for LDH Patients&quot; and demonstrations performed&#xD;
      by primary investigator after which we answered any questions that participants asked.&#xD;
      Brochure-based education took nearly 15 min, and participants could keep the brochures after&#xD;
      the education programme ended. By contrast, participants in the video group learned about&#xD;
      proper use of body mechanics from the &quot;Body Mechanics Educational Video for LDH Patients&quot;&#xD;
      presented on a laptop, after which we also answered any questions that participants asked.&#xD;
      Video-based education took nearly 15 min, and we provided CD-ROM with the video to the&#xD;
      participants. Unlike participants in the intervention groups, ones in the control group did&#xD;
      not receive structured education. Clinical nurses orally informed them about points to&#xD;
      consider while performing activities such as standing, rising from bed and lifting. Final&#xD;
      data collection took place in the sixth postoperative week, following the statement of the&#xD;
      American Association of Neuroscience Nurses that pain and disability begin to decrease and&#xD;
      that quality of life begins to increase 4-6 weeks after thoracolumbar surgery (Starkweather&#xD;
      et al., 2013). During the postoperative period, participants in all groups completed the&#xD;
      SF-MPQ, the ODI and the Physical Functioning and Bodily Pain subscales of the SF-36.&#xD;
      Participants in the brochure and video groups also completed the survey addressing their&#xD;
      satisfaction with the educational materials, whereas ones in the control group completed the&#xD;
      survey addressing their satisfaction with the clinical education that they received. We&#xD;
      collected data face-to-face with participants, which took approximately 20 min. Participants&#xD;
      who lived outside Ankara completed the respective survey via telephone interviews, which took&#xD;
      approximately 30 min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 15, 2017</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>prospective randomised controlled study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Because of only one investigator, there is no blinding</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Subscales of the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36)</measure>
    <time_frame>Change from quality of life at 6 weeks</time_frame>
    <description>Of the instrument's eight subscales and 36 items, we used the Physical Functioning (i.e. 10 items) and Bodily Pain (i.e. 2 items) subscales. Final scores for each subscale are calculated by dividing the score obtained by the number of items on the subscale. Final scores on the subscales range from 0 to 100; higher scores indicate higher quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>Change from disability at 6 weeks</time_frame>
    <description>The ODI has 10 questions addressing the intensity of pain, personal care, walking, sitting, standing and lifting behaviours, sex life, social life, sleep routines and travelling tendencies. Patients respond to each question on a 6-point Likert scale; for each question, scores range from 0 (i.e. no disability) to 5 (i.e. most severe disability). By contrast, total scores range between 0 and 50 and are interpreted to indicate minimal disability (0-4 points), moderate disability (5-14 points), severe disability (15-24 points), crippled (25-34 points) or bed-bound (35-50 points)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short-Form McGill Pain Questionnaire (SF-MPQ)</measure>
    <time_frame>Change from pain at 6 weeks</time_frame>
    <description>This questionnaire evaluated the reliability and validity of the Turkish version of the instrument. The scale evaluates acute pain and consists of sensory, affective and intensity subscales; higher scores indicate a higher intensity of pain.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Nursing Care</condition>
  <condition>Patient Education</condition>
  <arm_group>
    <arm_group_label>Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received educatıon via video material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brochure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received education via written material (brochure)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group received standart clinical education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video</intervention_name>
    <description>Video group receive body mechanic education via CD material,</description>
    <arm_group_label>Video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brochure</intervention_name>
    <description>Brochure group receive body mechanic education via written material (brochure)</description>
    <arm_group_label>Brochure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalised in preparation to receive LDH surgery and who volunteered to&#xD;
             participate&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Could read and write in Turkish&#xD;
&#xD;
          -  Scored between 1 and 3 in the classification systems of the American Society of&#xD;
             Anesthesiologists were preparing for their first LDH surgical operation&#xD;
&#xD;
          -  Could use CD-based educational materials&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalised in preparation to receive LDH surgery and who unvolunteered to&#xD;
             participate&#xD;
&#xD;
          -  All potential participants who had previously undergone LDH surgery&#xD;
&#xD;
          -  Could not use CD-based educational materials or had mental disorders liable to prevent&#xD;
             communication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Özgü Bakçek</last_name>
    <role>Principal Investigator</role>
    <affiliation>Health Science University Gulhane Faculty of Nursing, ANKARA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Özgü Bakçek</name>
      <address>
        <city>Ankara</city>
        <state>Eyalet/Yerleşke</state>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>December 30, 2018</last_update_submitted>
  <last_update_submitted_qc>December 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</investigator_affiliation>
    <investigator_full_name>Ozgu Bakcek</investigator_full_name>
    <investigator_title>Master of Science</investigator_title>
  </responsible_party>
  <keyword>Lumbar disc hernia surgery</keyword>
  <keyword>Body mechanics</keyword>
  <keyword>Patient education</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Disability</keyword>
  <keyword>Pain</keyword>
  <keyword>Nursing</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the study publish, we actually shared all procedurs.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data collection have been completed</ipd_time_frame>
  </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/NCT03792230
org study id: ozgubakcek
nct id: NCT03792230
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study evaluated the comparison of the different patient education methods. The study
      involved two stages of data collection: one during the preoperative period, the other during
      the sixth postoperative week.
Before commencing the study, we informed participants who met the inclusion criteria about
      the scope of the study and obtained their written and oral consent. Participants in each
      group completed the data collection form regarding patients' characteristics, the SF-MPQ, the
      ODI and the Physical Functioning and Bodily Pain subscales of the SF-36. A day before LDH
      (Lumbar Disc Hernia) surgery, participants in the control group received standard clinical
      education, whereas ones in the intervention groups received either video- or brochure-based
      education. Participants in the brochure group learned about the proper use of body mechanics
      from the "Body Mechanics Educational Brochure for LDH Patients" and demonstrations performed
      by primary investigator after which we answered any questions that participants asked.
      Brochure-based education took nearly 15 min, and participants could keep the brochures after
      the education programme ended. By contrast, participants in the video group learned about
      proper use of body mechanics from the "Body Mechanics Educational Video for LDH Patients"
      presented on a laptop, after which we also answered any questions that participants asked.
      Video-based education took nearly 15 min, and we provided CD-ROM with the video to the
      participants. Unlike participants in the intervention groups, ones in the control group did
      not receive structured education. Clinical nurses orally informed them about points to
      consider while performing activities such as standing, rising from bed and lifting. Final
      data collection took place in the sixth postoperative week, following the statement of the
      American Association of Neuroscience Nurses that pain and disability begin to decrease and
      that quality of life begins to increase 4-6 weeks after thoracolumbar surgery (Starkweather
      et al., 2013). During the postoperative period, participants in all groups completed the
      SF-MPQ, the ODI and the Physical Functioning and Bodily Pain subscales of the SF-36.
      Participants in the brochure and video groups also completed the survey addressing their
      satisfaction with the educational materials, whereas ones in the control group completed the
      survey addressing their satisfaction with the clinical education that they received. We
      collected data face-to-face with participants, which took approximately 20 min. Participants
      who lived outside Ankara completed the respective survey via telephone interviews, which took
      approximately 30 min.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective randomised controlled study
primary purpose: Supportive Care
masking: Single (Investigator)
masking description: Because of only one investigator, there is no blinding
measure: Subscales of the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36)
time frame: Change from quality of life at 6 weeks
description: Of the instrument's eight subscales and 36 items, we used the Physical Functioning (i.e. 10 items) and Bodily Pain (i.e. 2 items) subscales. Final scores for each subscale are calculated by dividing the score obtained by the number of items on the subscale. Final scores on the subscales range from 0 to 100; higher scores indicate higher quality of life
measure: Oswestry Disability Index (ODI)
time frame: Change from disability at 6 weeks
description: The ODI has 10 questions addressing the intensity of pain, personal care, walking, sitting, standing and lifting behaviours, sex life, social life, sleep routines and travelling tendencies. Patients respond to each question on a 6-point Likert scale; for each question, scores range from 0 (i.e. no disability) to 5 (i.e. most severe disability). By contrast, total scores range between 0 and 50 and are interpreted to indicate minimal disability (0-4 points), moderate disability (5-14 points), severe disability (15-24 points), crippled (25-34 points) or bed-bound (35-50 points)
measure: Short-Form McGill Pain Questionnaire (SF-MPQ)
time frame: Change from pain at 6 weeks
description: This questionnaire evaluated the reliability and validity of the Turkish version of the instrument. The scale evaluates acute pain and consists of sensory, affective and intensity subscales; higher scores indicate a higher intensity of pain.
arm group label: Video
arm group type: Experimental
description: This group received educatıon via video material
arm group label: Brochure
arm group type: Experimental
description: This group received education via written material (brochure)
arm group label: Control
arm group type: No Intervention
description: This group received standart clinical education
intervention type: Behavioral
intervention name: Video
description: Video group receive body mechanic education via CD material,
arm group label: Video
intervention type: Behavioral
intervention name: Brochure
description: Brochure group receive body mechanic education via written material (brochure)
arm group label: Brochure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Özgü Bakçek
role: Principal Investigator
affiliation: Health Science University Gulhane Faculty of Nursing, ANKARA
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
investigator full name: Ozgu Bakcek
investigator title: Master of Science
sharing ipd: Yes
ipd description: After the study publish, we actually shared all procedurs.
ipd info type: Study Protocol
ipd time frame: Data collection have been completed