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Completed

NCT Number: NCT04879095

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Civil Hospital

Hyderābād, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Translation of Dyspnea 12 in Urdu version

    Time frame: 4 Week

    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

Secondary outcomes

  1. Six minute Walk test

    Time frame: 4 week

    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

  2. Rate Perceived Exertion

    Time frame: 4 week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 10, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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