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COVID-19 and Its Effects on Chronic Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04715815
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sasikaan Nimmaanrat, Prince of Songkla University

Study Description
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Brief Summary:

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. Many factors can affect pain and its severity.

This study aims to explore how the COVID-19 affects chronic pain patients in terms of pain in general, intensity of pain, desire for pain treatment including follow up visits and pain medication refills as well as sleep.


Condition or disease Intervention/treatment
Chronic Pain Other: No intervention (only interview)

Detailed Description:

Research question

What are the effects of the COVID-19 on chronic pain patients in terms of pain and pain management?

Conceptual framework

The COVID-19 is a novel emerging infectious disease which has unimaginable and unbelievable large scale distressing effects worldwide.

Up to date, there is no study which aims to evaluate the effects of the COVID-19 on chronic pain patients in terms of pain and pain management. The previous survey in patients focused on the worrisome of them for getting this infection and their confidence in their government to control the COVID-19 situation in the US.

Materials and methods

This study is an in-depth interview. The in-depth interview is the principal method to collect qualitative data by setting up open-ended questions beforehand. Patients who are interviewed, can express their attitudes freely. This method is flexible which words, sentences and questions can be adjusted to suit each interviewee (participant). The process consists of active and intentional listening as well as ask on an in-depth basis. All conversations during the in-depth interview are tape-recorded.

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of COVID-19 on Chronic Pain Patients in Terms of Pain and Pain Management
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention (only interview)
    Interview

Outcome Measures
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Primary Outcome Measures :
  1. To explain how the COVID-19 affects chronic pain patients in terms of pain and pain management. [ Time Frame: January to December 2021 ]
    An in-depth interview will be conducted to find out how the COVID-19 affects chronic pain patients. The investigators will measure pain intensity and sleep disturbance level by using an 11-point numerical rating scale where 0 means that the patient's pain condition is not affected by the COVID-19 and 10 means that the patient's pain condition is maximally affected. The higher the score is the worse.


Secondary Outcome Measures :
  1. To explain how the COVID-19 affects chronic pain patients' psychological status. [ Time Frame: January to December 2021 ]
    An in-depth interview will be performed to find out how the COVID-19 affects the psychological aspect of chronic pain patients. The level of anxiety and stress will be measured using the 11-point verbal numerical rating scale where 0 means that the patient's psychological status is not affected by the COVID-19 and 10 means that the patient's psychological status is maximally affected. The higher the score is the worse.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 years and older who have chronic pain for at least 3 months' duration.
Criteria

Inclusion Criteria:

  • Patients with chronic pain who have been under the health care service of the pain clinic of Songklanagarind hospital.
  • Chronic pain patients are patients with persistent pain for at least 3 months. Pain can be from any etiologies.
  • The expected number of interviwees for this in-depth interview is 30 or until the gathered interview data are saturated.

Exclusion Criteria:

  • Patients who are not willing to participate this study and have time for an in person 'in-depth interview'.
  • Patients who are not influence in Thai language.
  • Patients who are physically or mentally too ill to participate this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715815


Contacts
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Contact: Sasikaan Nimmaanrat, MD +66887907842 snimmaanrat@yahoo.com.au

Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Sasikaan Nimmaanrat, MD Faculty of Medicine, Prince of Songkla University
More Information
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Publications of Results:

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Responsible Party: Sasikaan Nimmaanrat, Primary Investigator, Head of Pain Clinic, Clinical Associate Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT04715815    
Other Study ID Numbers: REC.63-359-8-1
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be shared upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations