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Clinical Trials/CTRI/2024/01/061955
CTRI/2024/01/061955Active, not recruitingNot Applicable

Cross-Cultural Adaptation and Validation of Hindi Version of Pulmonary Functional Status Questionnaire - Modified(PFSDQ-M)

Urvashi1 site in 1 country30 target enrollmentStarted: February 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
30
Locations
1

Study Overview

Brief Summary

Ethical approval of this study will taken from the student project committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandehwar (Deemed to be University). Study will be accordance with Helsinki Declaration Revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participation, 2017.

This study involves the translation of Pulmonary Functional Status and Dyspnea Questionnaire- Modified (PFSDQ-M) into Hindi language. There will be two phases of the study- 1st PHASE includes- Translation and validation of questionnaire according to DE Beaton guidelines having total five stages involve, Stage 1- Initial translation (Forward translation) into target (Hindi) language by two translators T1 and T2. Stage 2- synthesis of T1 and T2 into T12. Stage 3- back translation of T12 into original language(English) by two translator BT1 and BT2. Stage 4- involve Expert committee review and produce Pre-final version. Stage 5- Pretesting on 30 to 40 subject  for understanding the item including into the translated questionnaire. 2NDPHASE includes- cross-cultural adaptation by test-retest reliability.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Both male and female.
  • Age 18 to 75 years.
  • Diagnosed case of COPD Sufficient cognitive ability to comprehend the questionnaire.

Exclusion Criteria

  • Psychiatric disorders Communicatve and coginitive deficits Presence of complications Un-cooperative patients Patients who don’t give consent.

Investigators

Sponsor
Urvashi
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Urvashi

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Study Sites (1)

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