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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | control group with no intervention | |
| Experimental | intervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances |
| |
| Call | Experimental | intervention group receiving a phone cal with encouraging words after bond up of fixed appliances |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral | a WhatsApp message with encouraging words will be sent after bond up | |||
| Measure | Description | Time Frame |
|---|---|---|
| change in pain (VAS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety (STAI) | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of life (OHIP-16) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yasmin kamarudin | Contact | +60196161952 | yasminkamarudin@um.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University Malaya | Recruiting | Kuala Lumpur | 50603 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16214624 | Background | 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. | |
| 26070922 | Background | 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. |
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| Call |
| Behavioral |
a telephone call will be made after bond up to provide encoring words |
|
| everyday for 1 week post bond up |
| 23210546 | Background | 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. |
| 24987635 | Background | 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. |
| 2750720 | Background | 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. |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019002 | CD56 Antigen |
| ID | Term |
|---|---|
| D019006 | Neural Cell Adhesion Molecules |
| D015816 | Cell Adhesion Molecules, Neuronal |
| D015815 | Cell Adhesion Molecules |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D015415 | Biomarkers |
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