None listed
Conditions
Brief summary
This study will be a large scale cluster randomised controlled trial to test the effectiveness of facemasks in preventing acute respiratory viral infection including influenza and coronaviruses. The trial will compare the ‘use of (simple surgical) facemasks’ versus ‘no use of facemasks’ among pilgrims during the Hajj week (13 to 20 October, 2013, and 2 to 9 October 2014). Randomisation to each arm will be in a 1:1 ratio and will be done according to tents. For the intervention tents free masks will be provided to each person to be worn continuously for at least 5 days of stay at Mina. They will be given two diaries to record their flu-like symptoms and history of mask use. Data available from questionnaires, diaries and laboratory tests will be analysed to examine whether mask use makes a significant difference in reducing the frequency of laboratory confirmed respiratory virus infection.
Interventions
The intervention that we will use it for this study is ‘3M 'Trademark' Standard Tie-On Surgical Mask, Cat No: 1816’.
Masks will be provided to intervention group ‘mask tents’ to use it during the Hajj week in 2013 and 2014 (ie 13-18 October 2013 and 2-9 October 2014). Study staff will practically demonstrate the correct method of how to wear masks and help pilgrims to put on their mask for the first time. Each participant will be provided with 5 masks per day and a brochure with instructions a
The intervention that we will use it for this study is ‘3M 'Trademark' Standard Tie-On Surgical Mask, Cat No: 1816’. Masks will be provided to intervention group ‘mask tents’ to use it during the Hajj week in 2013 and 2014 (ie 13-18 October 2013 and 2-9 October 2014). Study staff will practically demonstrate the correct method of how to wear masks and help pilgrims to put on their mask for the first time. Each participant will be provided with 5 masks per day and a brochure with instructions about mask wearing and usage. The medical researchers will follow them each day to reminding them about recording their mask usage in a health diary.
Sponsors
The Children's Hospital at Westmead, National Centre for Immunisation Research and Surveillance (NCIRS)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Pilgrims from participating countries staying in their respective tents. Any gender, aged >/= 16 years. Informed consent has been agreed and signed.
Exclusion criteria
Children aged less than 16 years. Participation in another clinical trial investigating a medical intervention. Known contraindication to mask use (eg, allergy to surgical mask materials).
Outcome results
None listed