Pain, Anxiety, and Impacts on Oral Health-related Quality of Life for Patients With Orthodontic Treatment

NCT06150911 | Unknown

• 1 other identifier: KMUHIRB-E(II)-20230166
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 . The main questions it aims to answer are:

1. 1.The differences of pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment.
2. 2.The correlation of pain, anxiety and oral health-related quality of life in our participant
3. 3.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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

study population are orthodontic patients which are recruited from orthodontic department ,Kaohsiung medical university and local dental clinics

You may qualify if:

• Orthodontic patient with clinical diagnosis malocclusion
• Age from 18 to 60 years old

You may not qualify if:

• Systemic and psychological disease
• Craniofacial deformity
• Received orthodontic treatment beforehand

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung medical university

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Yu-Chuan Tseng, PHD

  Kaohsiung Medical University

  STUDY CHAIR

Central Study Contacts

Cheng-Tsung Huang, master

CONTACT

+886932700618; dentjames@yahoo.com.tw

Yu-Chuan Tseng, PHD

CONTACT

+886931830662; tsengyc@kmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 29, 2023
• Study Start: August 1, 2023
• Primary Completion: July 20, 2024
• Study Completion: December 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-07

Locations

TW (1)