Orthodontic Pain Clinical Trial
Official title:
The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
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.
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