Chronic PainNCT04715815
COVID-19 and Its Effects on Chronic Pain Patients
An observational study of Chronic Pain, run by Prince of Songkla University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients aged 18 years and older who have chronic pain for at least 3 months' duration.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of COVID-19 on Chronic Pain Patients in Terms of Pain and Pain Management
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- No intervention (only interview)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (only interview)Other
Interview
What is being measured
The primary outcome is the main question the study is designed to answer.
To explain how the COVID-19 affects chronic pain patients in terms of pain and pain management.
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.
Measured: January to December 2021
Secondary outcomes (1)
To explain how the COVID-19 affects chronic pain patients' psychological status.
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.
Measured: January to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasikaan Nimmaanrat, Prince of Songkla University
- Investigators
- Sasikaan Nimmaanrat, MD, Principal investigator, Faculty of Medicine, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715815
- Sponsor's protocol ID
- REC.63-359-8-1
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon request.
Publications
Wolf MS, Serper M, Opsasnick L, O'Conor RM, Curtis L, Benavente JY, Wismer G, Batio S, Eifler M, Zheng P, Russell A, Arvanitis M, Ladner D, Kwasny M, Persell SD, Rowe T, Linder JA, Bailey SC. Awareness, Attitudes, and Actions Related to COVID-19 Among Adults With Chronic Conditions at the Onset of the U.S. Outbreak: A Cross-sectional Survey. Ann Intern Med. 2020 Jul 21;173(2):100-109. doi: 10.7326/M20-1239. Epub 2020 Apr 9.
PubMed 32271861
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of COVID-19 on Chronic Pain Patients in Terms of Pain and Pain Management
- ClinicalTrials.gov ID
- NCT04715815
- Acronym / sponsor ID
- REC.63-359-8-1
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older who have chronic pain for at least 3 months' duration.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (only interview)Interview | Other | – |
Primary outcome
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.
1 secondary outcome
To explain how the COVID-19 affects chronic pain patients' psychological status.
Time frame: January to December 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Results publication: PubMed 32271861Wolf MS, Serper M, Opsasnick L, O'Conor RM, Curtis L, Benavente JY, Wismer G, Batio S, Eifler M, Zheng P, Russell A, Arvanitis M, Ladner D, Kwasny M, Persell SD, Rowe T, Linder JA, Bailey SC. Awareness, Attitudes, and Actions Related to COVID-19 Among Adults With Chronic Conditions at the Onset of the U.S. Outbreak: A Cross-sectional Survey. Ann Intern Med. 2020 Jul 21;173(2):100-109. doi: 10.7326/M20-1239. Epub 2020 Apr 9.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sasikaan Nimmaanrat, MD principal investigator
Faculty of Medicine, Prince of Songkla University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Prince of Songkla University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sasikaan Nimmaanrat, MD (+66887907842, snimmaanrat@yahoo.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explain how the COVID-19 affects chronic pain patients in terms of pain and pain management. (time frame: January to December 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.