NCT03816943

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Orthodontic Pain

Interventions

Type	Name	Description
BEHAVIORAL	Whatsapp	a WhatsApp message with encouraging words will be sent after bond up
BEHAVIORAL	Call	a telephone call will be made after bond up to provide encoring words

Timeline

• Start date: 2018-05-16
• Primary completion: 2019-05-01
• Completion: 2019-12-01
• First posted: 2019-01-25
• Last updated: 2019-01-25

Locations

1 site across 1 country: Malaysia