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

Not Applicable

• Conditions: Orthodontic Pain
• Interventions: Behavioral: Call; Behavioral: Whatsapp

• Registration Number: NCT03816943
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2018-05-16
• Status Verified: 2019-01
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Last Update Submitted: 2019-01-23
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-25
• Primary Completion: 2019-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Call	Call	intervention group receiving a phone cal with encouraging words after bond up of fixed appliances
Whatsapp	Whatsapp	intervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances

Primary Outcome Measures

Name	Time	Method
change in pain (VAS)	every day for 1 week post bond up	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

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety (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 daily change in anxiety post bonding of fixed appliances using the State-Trait Anxiety Inventory (STAI)

Trial Locations

Locations (1)

Faculty of Dentistry, University Malaya; 🇲🇾 Kuala Lumpur, Malaysia