Orthodontic PainNCT03816943
The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
A study testing Whatsapp and Call in people with Orthodontic Pain, run by University of Malaya at 1 site in Malaysia.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- Whatsapp and Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteMalaysia
- Study dates
- 16 May 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, University Malaya
Kuala Lumpur, 50603
yasmin kamarudin
About this study
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
Read the 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:
- Self-reported pain which consists of a Visual Analog Scale (VAS) and a question on analgesic consumption
- Anxiety questionnaire using the state scale of the Spielberger State-Trait Anxiety Inventory (STAI)
- 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
- Being tested
- Whatsapp, Call
- Keywords
- fixed appliances, orthodontics, quality of life, anxiety, pain, instant messaging, telephone call
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsappBehavioural
a WhatsApp message with encouraging words will be sent after bond up
CallBehavioural
a telephone call will be made after bond up to provide encoring words
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Whatsapp | |
| Call | Experimental | intervention group receiving a phone cal with encouraging words after bond up of fixed appliances Receives: Behavioral: Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every day for 1 week post bond up
Secondary outcomes (1)
Change in Anxiety (STAI)
Measure daily change in anxiety post bonding of fixed appliances using the State-Trait Anxiety Inventory (STAI)
Measured: 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 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start16 May 2018
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yasmin Kamarudin, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816943
- Sponsor's protocol ID
- RF004E-2018
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16214624Cozzani 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.
PubMed 26070922Keith 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.
PubMed 23210546Mansor 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.
PubMed 24987635Ngan 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.
PubMed 2750720
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
- ClinicalTrials.gov ID
- NCT03816943
- Acronym / sponsor ID
- RF004E-2018
- Conditions
- Orthodontic Pain
- Keywords
- fixed appliances, orthodontics, quality of life, anxiety, pain, instant messaging, telephone call
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Self-reported pain which consists of a Visual Analog Scale (VAS) and a question on analgesic consumption
- Anxiety questionnaire using the state scale of the Spielberger State-Trait Anxiety Inventory (STAI)
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –control group with no intervention |
| Experimental | Behavioral: Whatsappintervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances | |
| Call | Experimental | Behavioral: Callintervention group receiving a phone cal with encouraging words after bond up of fixed appliances |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whatsappa WhatsApp message with encouraging words will be sent after bond up | Behavioural | |
| Calla telephone call will be made after bond up to provide encoring words | Behavioural | Call |
Primary outcome
change in pain (VAS)
Time frame: 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
1 secondary outcome
Change in Anxiety (STAI)
Time frame: 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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 16214624Bartlett 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.
- Background: PubMed 26070922Cozzani 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.
- Background: PubMed 23210546Keith 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.
- Background: PubMed 24987635Mansor 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.
- Background: PubMed 2750720Ngan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whatsapp and Call in people with Orthodontic Pain, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasmin kamarudin (+60196161952, yasminkamarudin@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain (VAS) (time frame: every day for 1 week post bond up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816943, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.