Urdu Version of Fonseca Anamnestic Index: Reliability and Validity Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan, 38000
      • Recruiting
      • Ripah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pakistani population with or without temporo-mandibular disorders over the age 18-80 years and both genders.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2021
• Primary Completion (Anticipated): July 10, 2022
• Study Completion (Anticipated): July 12, 2022

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Validity; Reliability; Urdu Version; Temporomandibular Disorder; Fonseca Anamnestic Index; General Population
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: REC-FSD-00255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No