Clinical trial NCT03816943: The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
Official title: The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Pain
Keywords: fixed appliances
orthodontics
quality of life
anxiety
pain
instant messaging
telephone call
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 250
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in pain (VAS)
timeFrame: every day for 1 week post bond up
Secondary outcomes:
measure: Change in Anxiety (STAI)
timeFrame: 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 outcomes:
measure: Change in Quality of life (OHIP-16)
timeFrame: everyday for 1 week post bond up
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Dentistry, University Malaya
Study officials:
References:
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: 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: 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: 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: 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.