Orthodontic Pain
Conditions
Keywords
fixed appliances, orthodontics, quality of life, anxiety, pain, instant messaging, telephone call
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.
Interventions
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life (OHIP-16) | everyday for 1 week post bond up | 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. |
Countries
Malaysia
Contacts
Primary Contactyasmin kamarudin
Outcome results
None listed