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Clinical Trials/NCT05431829
NCT05431829
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N/A

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

Riphah International University1 site in 1 country140 target enrollmentMay 30, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Temporomandibular Disorder
Sponsor
Riphah International University
Enrollment
140
Locations
1
Primary Endpoint
Fonseca Anamnestic Index
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2021
End Date
July 12, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fonseca Anamnestic Index

Time Frame: 1st day

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.

Numeric Pain Rating Scale

Time Frame: 1st day

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

Headache impact Test-6

Time Frame: 1st day

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.

Short Form - 36

Time Frame: 1st day

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.

Dizziness Handicap Inventory

Time Frame: 1st day

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.

Neck Disability Index

Time Frame: 1st day

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.

Study Sites (1)

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