<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/NCT03816943</url>
  </required_header>
  <id_info>
    <org_study_id>RF004E-2018</org_study_id>
    <nct_id>NCT03816943</nct_id>
  </id_info>
  <brief_title>The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population</brief_title>
  <official_title>The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</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>
      Assessing the influence of a telephone call or Whatsapp instant text message post bond up of&#xD;
      fixed appliances on Pain Visual Analogue Scores, State-Trait Anxiety and Oral Health Quality&#xD;
      of Life&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology&#xD;
&#xD;
      Sample 250 new orthodontic patients that meet the research criteria, will be randomly divided&#xD;
      into 3 groups (Group 1: Phone call, Group 2: WhatsApp message, Group 3: Control).&#xD;
&#xD;
      Intervention During the bond up appointment, all participants will receive the same advice on&#xD;
      pain management. The control group (Group 3) will receive no post bond up intervention&#xD;
      whereas the remaining two groups will either receive a single instant text message via&#xD;
      WhatsApp (Group 2) or a telephone call (Group 1) 4-7 hours after bond up to provide pain&#xD;
      advice, motivation and reassurance. No further message or phone call will be carried out&#xD;
      unless the phone call group is unable to be contacted within the 4-7 hour time frame. In this&#xD;
      instance, a second phone call will be attempted within 24 hours. The timing of the&#xD;
      intervention is based on studies which suggest that pain starts approximately after 4 hours&#xD;
      and peaks at 24 hours.&#xD;
&#xD;
      Questionnaires&#xD;
&#xD;
      During the duration of the study, all patients will be required to complete three separate&#xD;
      online questionnaires at various time points over a 7-day period. The questionnaires include:&#xD;
&#xD;
        1. Self-reported pain which consists of a Visual Analog Scale (VAS) and a question on&#xD;
           analgesic consumption&#xD;
&#xD;
        2. Anxiety questionnaire using the state scale of the Spielberger State-Trait Anxiety&#xD;
           Inventory (STAI)&#xD;
&#xD;
        3. Oral health related quality of life using the Oral Health Impact Profile-14&#xD;
&#xD;
      The questionnaires will need to be completed prior to bond up to serve as base line records&#xD;
      (T0) and again 4 hours post bonding (T1) followed by daily for the next 7 days at the same&#xD;
      time (T2, T3....T7). All questionnaires will be completed online to facilitate easier&#xD;
      submission. A link to the online survey will be emailed directly to the patients daily as&#xD;
      each patient will have to complete the survey at different times depending on the timing of&#xD;
      their bond up appointment.&#xD;
&#xD;
      An additional pain questionnaire (TE) will be completed prior to extractions to make sure&#xD;
      pain levels have returned to normal during the bond up appointment.&#xD;
&#xD;
      Statistical analysis Statistical Package for Social Sciences (SPSS) will be used to analyse&#xD;
      the data.&#xD;
&#xD;
      To reduce risk of bias, the clinician, patient and the statistician will be blinded to the&#xD;
      intervention groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 16, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">May 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in pain (VAS)</measure>
    <time_frame>every day for 1 week post bond up</time_frame>
    <description>measure daily change in pain post bonding of fixed appliances using a 10mm pain visual analogue scale. 0mm = no pain and 100mm = worst pain imaginable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety (STAI)</measure>
    <time_frame>everyday for 1 week post bond up. It consists of 40 statements which require the participant to rate using a 4 point likert scale.Total scores can range between 40 to 160. Higher scores indicate increased anxiety .</time_frame>
    <description>Measure daily change in anxiety post bonding of fixed appliances using the State-Trait Anxiety Inventory (STAI)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Quality of life (OHIP-16)</measure>
    <time_frame>everyday for 1 week post bond up</time_frame>
    <description>Measure daily change in Oral health quality of life using the modified short Malay version of the Oral Health Impact Profile (OHIP-16M).It consists of a Likert scale and coded as: 1=never, 2=hardly ever, 3=occasionally, 4=fairly often, and 5=very often. The OHIP-16[M] scores range from 16 to 80, where 16 indicates no impact and 80 indicates the worst impact of one's oral health on QOL.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Orthodontic Pain</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group with no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whatsapp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention group receiving a phone cal with encouraging words after bond up of fixed appliances</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Whatsapp</intervention_name>
    <description>a WhatsApp message with encouraging words will be sent after bond up</description>
    <arm_group_label>Whatsapp</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Call</intervention_name>
    <description>a telephone call will be made after bond up to provide encoring words</description>
    <arm_group_label>Call</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New patients requiring fixed preadjusted appliances in both arches&#xD;
&#xD;
          -  Age ≥ 16 years old&#xD;
&#xD;
          -  Patients of Mongoloid ethnicity&#xD;
&#xD;
          -  Patients with access to a cellular phone with Whatsapp instant messaging app&#xD;
&#xD;
          -  Patients with access to internet services and email account for questionnaire&#xD;
             completion&#xD;
&#xD;
          -  Patients with partial bond up e.g delayed bond up of lower incisors or upper laterals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of reported chronic use of analgesic medication&#xD;
&#xD;
          -  History of chronic pain related pathology or disease&#xD;
&#xD;
          -  History of previous fixed orthodontic intervention&#xD;
&#xD;
          -  Patients that have recently had teeth extracted less than 2 weeks prior to bond up&#xD;
&#xD;
          -  Patients requiring bond of both arches on separate days&#xD;
&#xD;
          -  Syndromic patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>yasmin kamarudin</last_name>
    <phone>+60196161952</phone>
    <email>yasminkamarudin@um.edu.my</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Dentistry, University Malaya</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50603</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yasmin kamarudin</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Bartlett BW, Firestone AR, Vig KW, Beck FM, Marucha PT. The influence of a structured telephone call on orthodontic pain and anxiety. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):435-41. doi: 10.1016/j.ajodo.2004.06.033.</citation>
    <PMID>16214624</PMID>
  </reference>
  <reference>
    <citation>Cozzani M, Ragazzini G, Delucchi A, Barreca C, Rinchuse DJ, Servetto R, Calevo MG, Piras V. Self-reported pain after orthodontic treatments: a randomized controlled study on the effects of two follow-up procedures. Eur J Orthod. 2016 Jun;38(3):266-71. doi: 10.1093/ejo/cjv032. Epub 2015 Jun 11.</citation>
    <PMID>26070922</PMID>
  </reference>
  <reference>
    <citation>Keith DJ, Rinchuse DJ, Kennedy M, Zullo T. Effect of text message follow-up on patient's self-reported level of pain and anxiety. Angle Orthod. 2013 Jul;83(4):605-10. doi: 10.2319/091812-742.1. Epub 2012 Dec 4.</citation>
    <PMID>23210546</PMID>
  </reference>
  <reference>
    <citation>Mansor N, Saub R, Othman SA. Changes in the oral health-related quality of life 24 h following insertion of fixed orthodontic appliances. J Orthod Sci. 2012 Oct;1(4):98-102. doi: 10.4103/2278-0203.105880.</citation>
    <PMID>24987635</PMID>
  </reference>
  <reference>
    <citation>Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.</citation>
    <PMID>2750720</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaya</investigator_affiliation>
    <investigator_full_name>Dr Yasmin Kamarudin</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>fixed appliances</keyword>
  <keyword>orthodontics</keyword>
  <keyword>quality of life</keyword>
  <keyword>anxiety</keyword>
  <keyword>pain</keyword>
  <keyword>instant messaging</keyword>
  <keyword>telephone call</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03816943
org study id: RF004E-2018
nct id: NCT03816943
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessing the influence of a telephone call or Whatsapp instant text message post bond up of
      fixed appliances on Pain Visual Analogue Scores, State-Trait Anxiety and Oral Health Quality
      of Life
Methodology

      Sample 250 new orthodontic patients that meet the research criteria, will be randomly divided
      into 3 groups (Group 1: Phone call, Group 2: WhatsApp message, Group 3: Control).

      Intervention During the bond up appointment, all participants will receive the same advice on
      pain management. The control group (Group 3) will receive no post bond up intervention
      whereas the remaining two groups will either receive a single instant text message via
      WhatsApp (Group 2) or a telephone call (Group 1) 4-7 hours after bond up to provide pain
      advice, motivation and reassurance. No further message or phone call will be carried out
      unless the phone call group is unable to be contacted within the 4-7 hour time frame. In this
      instance, a second phone call will be attempted within 24 hours. The timing of the
      intervention is based on studies which suggest that pain starts approximately after 4 hours
      and peaks at 24 hours.

      Questionnaires

      During the duration of the study, all patients will be required to complete three separate
      online questionnaires at various time points over a 7-day period. The questionnaires include:

        1. Self-reported pain which consists of a Visual Analog Scale (VAS) and a question on
           analgesic consumption

        2. Anxiety questionnaire using the state scale of the Spielberger State-Trait Anxiety
           Inventory (STAI)

        3. Oral health related quality of life using the Oral Health Impact Profile-14

      The questionnaires will need to be completed prior to bond up to serve as base line records
      (T0) and again 4 hours post bonding (T1) followed by daily for the next 7 days at the same
      time (T2, T3....T7). All questionnaires will be completed online to facilitate easier
      submission. A link to the online survey will be emailed directly to the patients daily as
      each patient will have to complete the survey at different times depending on the timing of
      their bond up appointment.

      An additional pain questionnaire (TE) will be completed prior to extractions to make sure
      pain levels have returned to normal during the bond up appointment.

      Statistical analysis Statistical Package for Social Sciences (SPSS) will be used to analyse
      the data.

      To reduce risk of bias, the clinician, patient and the statistician will be blinded to the
      intervention groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: change in pain (VAS)
time frame: every day for 1 week post bond up
description: measure daily change in pain post bonding of fixed appliances using a 10mm pain visual analogue scale. 0mm = no pain and 100mm = worst pain imaginable
measure: Change in Anxiety (STAI)
time frame: everyday for 1 week post bond up. It consists of 40 statements which require the participant to rate using a 4 point likert scale.Total scores can range between 40 to 160. Higher scores indicate increased anxiety .
description: Measure daily change in anxiety post bonding of fixed appliances using the State-Trait Anxiety Inventory (STAI)
measure: Change in Quality of life (OHIP-16)
time frame: everyday for 1 week post bond up
description: Measure daily change in Oral health quality of life using the modified short Malay version of the Oral Health Impact Profile (OHIP-16M).It consists of a Likert scale and coded as: 1=never, 2=hardly ever, 3=occasionally, 4=fairly often, and 5=very often. The OHIP-16[M] scores range from 16 to 80, where 16 indicates no impact and 80 indicates the worst impact of one's oral health on QOL.
arm group label: Control
arm group type: No Intervention
description: control group with no intervention
arm group label: Whatsapp
arm group type: Experimental
description: intervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances
arm group label: Call
arm group type: Experimental
description: intervention group receiving a phone cal with encouraging words after bond up of fixed appliances
intervention type: Behavioral
intervention name: Whatsapp
description: a WhatsApp message with encouraging words will be sent after bond up
arm group label: Whatsapp
intervention type: Behavioral
intervention name: Call
description: a telephone call will be made after bond up to provide encoring words
arm group label: Call
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yasmin kamarudin
phone: +60196161952
email: yasminkamarudin@um.edu.my
facility: 
status: Recruiting
contact: 
country: Malaysia
citation: Bartlett BW, Firestone AR, Vig KW, Beck FM, Marucha PT. The influence of a structured telephone call on orthodontic pain and anxiety. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):435-41. doi: 10.1016/j.ajodo.2004.06.033.
PMID: 16214624
citation: Cozzani M, Ragazzini G, Delucchi A, Barreca C, Rinchuse DJ, Servetto R, Calevo MG, Piras V. Self-reported pain after orthodontic treatments: a randomized controlled study on the effects of two follow-up procedures. Eur J Orthod. 2016 Jun;38(3):266-71. doi: 10.1093/ejo/cjv032. Epub 2015 Jun 11.
PMID: 26070922
citation: Keith DJ, Rinchuse DJ, Kennedy M, Zullo T. Effect of text message follow-up on patient's self-reported level of pain and anxiety. Angle Orthod. 2013 Jul;83(4):605-10. doi: 10.2319/091812-742.1. Epub 2012 Dec 4.
PMID: 23210546
citation: Mansor N, Saub R, Othman SA. Changes in the oral health-related quality of life 24 h following insertion of fixed orthodontic appliances. J Orthod Sci. 2012 Oct;1(4):98-102. doi: 10.4103/2278-0203.105880.
PMID: 24987635
citation: Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
PMID: 2750720
responsible party type: Principal Investigator
investigator affiliation: University of Malaya
investigator full name: Dr Yasmin Kamarudin
investigator title: Principle investigator
sharing ipd: No