Urdu Version of Fonseca Anamnestic Index: Reliability and Validity Study

Temporomandibular Disorder Clinical Trial

Official title:

Analysis of Psychometric Properties and Cultural Adaptation of Urdu Version of Fonseca Anamnestic Index in Pakistani Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431829
• Other study ID #: REC-FSD-00255
• Status: Recruiting
• Start date: May 30, 2021
• Est. completion date: July 12, 2022

Study information

• Verified date: June 2022
• Source: Riphah International University
• Contact: Muhammad Kashif
• Phone: +92418777210
• Email: kashif.shaffi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of study is to translate and culturally adapt Fonseca Anamnestic Index into Urdu language and to investigate the reliability and validity in Pakistani population over the age 18 years.

Description:

The English version of the Fonseca Anamnestic Index will be translated and culturally adapted as per previous recommendation. In Pakistani general population, Urdu Version of Fonseca Anamnestic Index will distributed among 140 participants choose by random sampling technique based on pre-defined inclusion and exclusion criteria. To test inter and intra-observer reliability of the final Urdu Version of Fonseca Anamnestic Index questionnaire will be filled on the same day, by two observers, and for the Inter-Observers assessment, with an interval of 30 minute between the first and the second application. Third assessment will carried out after 7 days by Observer-1, for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- re-test reliability will be assessed using an intra-class correlation coefficient. The Urdu Version of Fonseca Anamnestic Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 12, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient with the age of 18 years.

• Having any previous history of temporo-mandibular joint pain

• Having any current condition of temporo-mandibular disorders.

• Both Genders are included equally.

Exclusion Criteria:

• Inability to understand or follow the instructions of the Fonseca Anamnestic Index.

• Suffering from any neurological condition.

• Suffering from any unstable medical condition.

• Patients with rheumatoid arthritis were also excluded

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fonseca Anamnestic Index	It is a scale proposed to identify and determine the severity of temporo-mandibular disorder through 10 question being designed in the form of a questionnaire which is then to be filled and completed by the population.	1st day
Primary	Numeric Pain Rating Scale	The numeric pain rating scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain	1st day
Primary	Short Form - 36	The Short Form - 36 which is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers.	1st day
Primary	Dizziness Handicap Inventory	Dizziness and vertigo sensations were measured with the dizziness handicap inventory, which is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders.	1st day
Primary	Headache impact Test-6	The headache impact test is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.	1st day
Primary	Neck Disability Index	The neck disability index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50.	1st day