The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population

January 23, 2019 updated by: Dr Yasmin Kamarudin, University of Malaya
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • Faculty of Dentistry, University Malaya
        • Contact:
          • yasmin kamarudin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New patients requiring fixed preadjusted appliances in both arches
  • Age ≥ 16 years old
  • Patients of Mongoloid ethnicity
  • Patients with access to a cellular phone with Whatsapp instant messaging app
  • Patients with access to internet services and email account for questionnaire completion
  • Patients with partial bond up e.g delayed bond up of lower incisors or upper laterals

Exclusion Criteria:

  • History of reported chronic use of analgesic medication
  • History of chronic pain related pathology or disease
  • History of previous fixed orthodontic intervention
  • Patients that have recently had teeth extracted less than 2 weeks prior to bond up
  • Patients requiring bond of both arches on separate days
  • Syndromic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
control group with no intervention
Experimental: Whatsapp
intervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances
Behavioral: Whatsapp
a WhatsApp message with encouraging words will be sent after bond up
Experimental: Call
intervention group receiving a phone cal with encouraging words after bond up of fixed appliances
Behavioral: Call
a telephone call will be made after bond up to provide encoring words

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain (VAS)
Time Frame: every day for 1 week post bond up
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
every day for 1 week post bond up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Measure daily change in anxiety post bonding of fixed appliances using the State-Trait Anxiety Inventory (STAI)
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 .

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life (OHIP-16)
Time Frame: everyday for 1 week post bond up
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.
everyday for 1 week post bond up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RF004E-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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