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ID
Source
Brief title
Health condition
Anxiety, depression, hypoxia, dyspnoea
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective dyspnoea, as assessed by a composite of the Borg scale and MRC dyspnoea scale and its correlation to hypoxia in mask wearers. Time point is 30 minutely oxygen saturation measurements and subjective dyspnoea scales as assessed during a 4 hour period of mask wearing.
Secondary outcome
Subjective dyspnoea scale correlation to baseline PROMIS anxiety and depression, BMI, measured heart rate, past medical history including COPD, BMI and psychological diagnoses, activity.
Background summary
Hospital personnel were recruited to wear two masks for 4 hours each, a standard 3 layer surgical mask, fit tested N95 mask, and also a control arm of no facial covering (control arm). The order in which they wore the masks/control was randomised. Baseline demographics were collected, including psychometric testing (PROMIS anxiety and depression PROMs).
Study objective
Use of any mask (surgical or N95) in a standard day of work for hospital staff, may result in subjective feelings of dyspnoea. These symptoms of dyspnoea do not correlate to a decreased oxygen saturation, but do correlate to baseline participant anxiety or depression.
Study design
Baseline and 30 minutely measurements while wearing masks or control.
Intervention
Wearing of masks (surgical and N95) for 4 hours each. Crossover design, with each participant wearing both masks in a randomised order. Also included in randomisation is a control arm (no mask wearing).
Inclusion criteria
Volunteer hospital personnel at Flinders Medical Centre and Noarlunga Health Services who are fit tested for N95 masks and shall work 3 days in a row.
Exclusion criteria
Allergy to masks, not fit tested, no fit tested N95 available, participant refusal, not working 3 consecutive days
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL9143 |
Other | METC FMC : NONE yet |