Clinical trial NCT05431829: Urdu Version of Fonseca Anamnestic Index: Reliability and Validity Study
Official title: Analysis of Psychometric Properties and Cultural Adaptation of Urdu Version of Fonseca Anamnestic Index in Pakistani Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Temporomandibular Disorder
Keywords: Fonseca Anamnestic Index
Urdu Version
Reliability
Validity
Temporomandibular Disorder
General Population
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani population with or without temporo-mandibular disorders over the age 18-80 years and both genders.

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.

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

Primary outcomes:
measure: Fonseca Anamnestic Index
timeFrame: 1st day
measure: Numeric Pain Rating Scale
timeFrame: 1st day
measure: Short Form - 36
timeFrame: 1st day
measure: Dizziness Handicap Inventory
timeFrame: 1st day
measure: Headache impact Test-6
timeFrame: 1st day
measure: Neck Disability Index
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References: