PainNCT06150911
Pain, Anxiety, and Impacts on Oral Health-related Quality of Life for Patients With Orthodontic Treatment
An observational study of Pain and Anxiety, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to learn about pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment. The recruited participants with good health are from Kaohsiung medical university and local dental clinics . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Oral Health Related Quality of Life
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: study population are orthodontic patients which are recruited from orthodontic department ,Kaohsiung medical university and local dental clinics
Who may be able to join
- Orthodontic patient with clinical diagnosis malocclusion
- Age from 18 to 60 years old
Who cannot join
- Systemic and psychological disease
- Craniofacial deformity
- Received orthodontic treatment beforehand
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung medical university
Kaohsiung City
Yu-Chuan Tseng, PHD, +886931830662, tsengyc@kmu.edu.tw
About this study
Official title: A Study of Pain, Anxiety, and Impacts on Oral Health-related Quality of Life(OHRQoL) for Patients Before, During and After Orthodontic Treatment
The goal of this observational study is to learn about pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment. The recruited participants with good health are from Kaohsiung medical university and local dental clinics .
The main questions it aims to answer are:
- The differences of pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment.
- The correlation of pain, anxiety and oral health-related quality of life in our participant
- The differences of seven domain in OHIP-14 scale in our participants The participants are asked to complete a self-administered in different time point.
Read the detailed description
Orthodontic treatment is a common dental procedure aimed at improving teeth and bite alignment issues. Patients may experience various challenges before, during, and after orthodontic treatment, including pain, anxiety, and the impact on oral health-related quality of life. Here are some aspects to consider in researching these areas:
Pain: Orthodontic treatment typically causes a certain level of discomfort and pain. Research can focus on assessing changes in the intensity and frequency of pain experienced by patients before, during, and after treatment. Pain can be evaluated using visual analog scales or numerical rating scales, and the duration and relief of pain should be tracked.
Anxiety: Orthodontic treatment may induce anxiety and stress in some patients. Studies can assess anxiety levels at different stages of treatment through surveys or psychological measurement tools like anxiety assessment scales. Additionally, observing patients' behavior and emotional responses during treatment can provide insights into their anxiety levels.
Oral Health-Related Quality of Life: The success of orthodontic treatment is not solely determined by tooth movement but also relates to patients' oral health-related quality of life indicators. These indicators may include oral hygiene habits, dietary changes, and satisfaction with the treatment process. Questionnaires, oral examinations, and oral health-related quality of life assessment tools can be used to evaluate these aspects.
Researching these areas can help us gain a better understanding of patients' experiences and needs during orthodontic treatment. This, in turn, can aid in improving treatment methods and providing better patient care. Furthermore, research findings can be used to offer education and guidance to patients before, during, and after treatment to alleviate their pain and anxiety and promote oral health maintenance.
In summary, orthodontic treatment can significantly benefit patients in terms of addressing bite alignment issues and improving their psychological, physiological, and social interactions. However, in Taiwan, there is a lack of systematic research on the changes in pain, anxiety, and oral health-related quality of life indicators experienced by patients before, during, and after orthodontic treatment. Therefore, this study aims to investigate these issues through structured questionnaires among patients undergoing orthodontic treatment.
- Conditions
- Pain, Anxiety, Oral Health Related Quality of Life
- Keywords
- Visual Analogue Scale(VAS) pain scale, Generalized Anxiety Disorder 7-item (GAD-7) scale, Oral health impact profile-14(OHIP-14) scale
- Medical subject headings
- Pain, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale(VAS) pain scale
The pain scale illustrate the pain level which ranging from 0~10. 0 represent no pain,and 10 represent the most painful sensation. The participant will choose the most suitable pain sensation during the testing time point.
Measured: 2 years
Generalized Anxiety Disorder 7-item (GAD-7) scale
The GAD-7 scale using seven questions to test the anxiety level measurement caused by any problems, and how difficult have these problems interfere you to do your work, take care of things at home, or get along with other people? Each question is measured with four point Likert's scale from 0~3 and then sum up to have the total score. The total score ranging from 0~4: extreme mild anxiety / 5~9: mild anxiety/ 10~14:moderate anxiety/15~21: severe anxiety.
Measured: 2 years
Oral health impact profile(OHIP)-14 scale; self-administered questionnaire
The OHIP-14 scale was used to measure the participants' oral health related quality of life and it has seven conceptualized domains (two items per domain): functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.In which, respondents are asked to rate how frequently they experienced an oral health impact (as described by each item). In turn, the response to each item is scored on a five-point Likert scale: 0, never; 1, hardly ever; 2, occasionally; 3, fairly often; and 4, very often or every day. Thus, summary OHIP-14 scores can range from 0 to 56. A high total value indicates a high negative impact on the OHRQoL.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Aug 2023
- Primary completion20 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chuan Tseng, PHD, Study chair, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150911
- Sponsor's protocol ID
- KMUHIRB-E(II)-20230166
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Pain, Anxiety, and Impacts on Oral Health-related Quality of Life(OHRQoL) for Patients Before, During and After Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT06150911
- Acronym / sponsor ID
- KMUHIRB-E(II)-20230166
- Conditions
- Pain, Anxiety, Oral Health Related Quality of Life
- Keywords
- Visual Analogue Scale(VAS) pain scale, Generalized Anxiety Disorder 7-item (GAD-7) scale, Oral health impact profile-14(OHIP-14) scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Nov 2023 (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.
The goal of this observational study is to learn about pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment. The recruited participants with good health are from Kaohsiung medical university and local dental clinics .
The main questions it aims to answer are:
- The differences of pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment.
- The correlation of pain, anxiety and oral health-related quality of life in our participant
- The differences of seven domain in OHIP-14 scale in our participants The participants are asked to complete a self-administered in different time point.
Detailed description
Orthodontic treatment is a common dental procedure aimed at improving teeth and bite alignment issues. Patients may experience various challenges before, during, and after orthodontic treatment, including pain, anxiety, and the impact on oral health-related quality of life. Here are some aspects to consider in researching these areas:
Pain: Orthodontic treatment typically causes a certain level of discomfort and pain. Research can focus on assessing changes in the intensity and frequency of pain experienced by patients before, during, and after treatment. Pain can be evaluated using visual analog scales or numerical rating scales, and the duration and relief of pain should be tracked.
Anxiety: Orthodontic treatment may induce anxiety and stress in some patients. Studies can assess anxiety levels at different stages of treatment through surveys or psychological measurement tools like anxiety assessment scales. Additionally, observing patients' behavior and emotional responses during treatment can provide insights into their anxiety levels.
Oral Health-Related Quality of Life: The success of orthodontic treatment is not solely determined by tooth movement but also relates to patients' oral health-related quality of life indicators. These indicators may include oral hygiene habits, dietary changes, and satisfaction with the treatment process. Questionnaires, oral examinations, and oral health-related quality of life assessment tools can be used to evaluate these aspects.
Researching these areas can help us gain a better understanding of patients' experiences and needs during orthodontic treatment. This, in turn, can aid in improving treatment methods and providing better patient care. Furthermore, research findings can be used to offer education and guidance to patients before, during, and after treatment to alleviate their pain and anxiety and promote oral health maintenance.
In summary, orthodontic treatment can significantly benefit patients in terms of addressing bite alignment issues and improving their psychological, physiological, and social interactions. However, in Taiwan, there is a lack of systematic research on the changes in pain, anxiety, and oral health-related quality of life indicators experienced by patients before, during, and after orthodontic treatment. Therefore, this study aims to investigate these issues through structured questionnaires among patients undergoing orthodontic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- study population are orthodontic patients which are recruited from orthodontic department ,Kaohsiung medical university and local dental clinics
Key inclusion criteria (2 listed)
- Orthodontic patient with clinical diagnosis malocclusion
- Age from 18 to 60 years old
Key exclusion criteria (3 listed)
- Systemic and psychological disease
- Craniofacial deformity
- Received orthodontic treatment beforehand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analogue Scale(VAS) pain scale
Time frame: 2 years
The pain scale illustrate the pain level which ranging from 0~10. 0 represent no pain,and 10 represent the most painful sensation. The participant will choose the most suitable pain sensation during the testing time point.
Generalized Anxiety Disorder 7-item (GAD-7) scale
Time frame: 2 years
The GAD-7 scale using seven questions to test the anxiety level measurement caused by any problems, and how difficult have these problems interfere you to do your work, take care of things at home, or get along with other people? Each question is measured with four point Likert's scale from 0~3 and then sum up to have the total score. The total score ranging from 0~4: extreme mild anxiety / 5~9: mild anxiety/ 10~14:moderate anxiety/15~21: severe anxiety.
Oral health impact profile(OHIP)-14 scale; self-administered questionnaire
Time frame: 2 years
The OHIP-14 scale was used to measure the participants' oral health related quality of life and it has seven conceptualized domains (two items per domain): functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.In which, respondents are asked to rate how frequently they experienced an oral health impact (as described by each item). In turn, the response to each item is scored on a five-point Likert scale: 0, never; 1, hardly ever; 2, occasionally; 3, fairly often; and 4, very often or every day. Thus, summary OHIP-14 scores can range from 0 to 56. A high total value indicates a high negative impact on the OHRQoL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Yu-Chuan Tseng, PHD study chair
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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 6 Dec 2023. 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 Taiwan. 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 Cheng-Tsung Huang, master (+886932700618, dentjames@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale(VAS) pain scale (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.