Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)

COPD Clinical Trial

Official title:

Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879095
• Other study ID #: REC00780 Mehwish Shabbir
• Status: Completed
• Start date: August 13, 2020
• Est. completion date: April 24, 2021

Study information

• Verified date: June 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dyspnea is a distressing symptom with pain like perception. The object of study is to translate a tool that measure overall dyspnea severity. Although many scales are available to assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to assess dyspnea in terms of intensity, quality and emotional response.

Description:

Aim of study is to translate a clinical validate of Urdu version of D-12 in COPDs patients. The study will measure reliability & validity of dyspnea in Urdu version. No study has been conducted in our region to translate D-12 follow the proper cross culture adaptation. Therefor the instrument will translate in our language adapting proper cross culture guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 24, 2021
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient age between 40-65 with diagnosis of COPD
• Outpatient individual who are on follow up
• Healthy individual
• Those who can read and understand English and Urdu as well.

Exclusion Criteria:

• Patient with cognitive impairment or sensory disorder were exclude.
• Patient physical disability
• Refuse to perform test

Related Conditions & MeSH terms

• COPD
• Dyspnea

Locations

Country	Name	City	State
Pakistan	Civil Hospital	Hyderabad	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Translation of Dyspnea 12 in Urdu version	D12 scale is used in assessment of dyspnea severity using its descriptors consist of sensory quality and effective component. It's a 12 item scale from 1-7 item related to physical component score (quality of sensation of dyspnea) & from 8-12 related to emotional response of this sensation. Each item was graded on 4 point scale as none, mild, moderate & severe and scored as 0 to 3 to get final score of 0 to 36; Forward conversion; Professional panel; Backward conversion; Pretesting; Final Form The translation of Dyspnea12 (D-12) Questionnaire into Urdu was done by using Cross Cultural Adaptation techniques according to WHO guideline it involve the following steps; Forward conversion; Professional panel; Backward conversion; Pretesting; Final Form	4 Week
Secondary	Six minute Walk test	It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as outcome by which to compare changes in performance capacity. 30-metre stretch of unimpeded walkway is used and patient is instructed to walk as far as possible for 6 minutes. Test retest reliability of 6MWT showed good internal consistency (ICC=0.9) in patients with heart failure patients	4 week
Secondary	Rate Perceived Exertion	The scale is used to monitor and guide exercise intensity and help in measure how hard your body is working when you exercise. It gives estimate of your heart rate and exercise intensity zone. The scale ranges from 6 -20. 6 indicate no exertion and 20 denotes maximum exertion, it is simple numerical list.	4 week