The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
NCT ID: NCT03816943
Last Updated: 2019-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2018-05-16
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Control
control group with no intervention
No interventions assigned to this group
intervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances
a WhatsApp message with encouraging words will be sent after bond up
Call
intervention group receiving a phone cal with encouraging words after bond up of fixed appliances
Call
a telephone call will be made after bond up to provide encoring words
Interventions
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a WhatsApp message with encouraging words will be sent after bond up
Call
a telephone call will be made after bond up to provide encoring words
Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Dr Yasmin Kamarudin
Principle investigator
Locations
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Faculty of Dentistry, University Malaya
Kuala Lumpur, , Malaysia
Countries
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Central Contacts
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Facility Contacts
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yasmin kamarudin
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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RF004E-2018
Identifier Type: -
Identifier Source: org_study_id
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