Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available. In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent. The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests.
All consecutive subjects coming to the 2 dedicated centers for COVID-19 screening in Clermont-Ferrand University hospital (one for medical students and one for the general population) will be asked to be included in the present study. They will be randomly assigned to either supervised self-swabbing followed by conventional swabbing led by a healthcare professional or the other way round. All the subjects will have to complete a brief questionnaire including demographical characteristics (age, sex, height, weight, eye color), potential symptoms (asthenia, fever, anosmia…) anticipated pain and discomfort and previous nasopharyngeal swabbing experience. Pain, discomfort and overall acceptability of the procedure will be completed just after completion of the swabbing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
assessed using consistency of COVID-19 RT-PCR results for both sampling modalities (Self- swabbing versus conventional-swabbing). If non-inferiority is confirmed on this criterion, pain will be tested.
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Correlation between age, sex and swabbing-induced pain
Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain)
Time frame: 5 minutes after the end of the procedure
Correlation between eye color and swabbing-induced pain
Eye-color self-reported by the subject on a validated 14 item scale and pain score on the numeric rating scale (NRS) (0 to 10; higher scores meaning more pain)
Time frame: 5 minutes after the end of the procedure
Correlation between eye color and swabbing-induced discomfort
Eye-color self-reported by the subject on a validated 14 item scale and discomfort score on numeric rating scale (0 to 10; higher scores meaning more discomfort)
Time frame: 5 minutes after the end of the procedure
Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain
symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
Time frame: 5 minutes after the end of the procedure
Correlation between body mass index and swabbing-induced pain
symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
Time frame: 5 minutes after the end of the procedure
Correlation between anticipated pain and actual pain
anticipated and actual pain self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
Time frame: 5 minutes after the end of the procedure
Correlation between anticipated discomfort and actual discomfort.
anticipated and actual discomfort self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
Time frame: 5 minutes after the end of the procedure
Richness assessment for respiratory cells
Ct value of beta-globin gene
Time frame: Day 0
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
assessed using a Numerical Rating Scale (0 indicating no pain and 10 the worst imaginable pain). If non-inferiority is confirmed on this criterion, discomfort will be tested
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort
assessed using a Numerical Rating Scale (0 indicating no discomfort and 10 the worst imaginable discomfort). If non-inferiority is confirmed on this criterion, acceptability will be tested
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability
assessed using a Numerical Rating Scale (0 indicating that the procedure is not acceptable at all and 10 that the procedure is perfectly well accepted).
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.