None listed
Conditions
Brief summary
Lay hypothesis: This pilot crossover RCT hypothesises that class II graduated compression stockings and portable intermittent pneumatic calf pumps will reduce work-related calf swelling in hospital staff who stand for prolonged periods compared with no intervention. The study also hypothesises that these devices will be acceptable and usable in a real clinical work environment, providing feasibility data and preliminary effect sizes to inform a larger trial This single-centre crossover pilot RCT will enrol about 25 Dunedin Hospital clinical staff who stand for at least three hours per shift to compare no intervention, class II graduated compression stockings, and portable intermittent pneumatic calf pumps over three five-day periods. The primary outcome is change in Calf circumference from baseline to day two, with secondary outcomes including questionnaire results, adverse events, and qualitative feedback on acceptability and usability. Participants will be randomised 1:1:1 to intervention order, wear stockings for entire shifts or use calf pumps twice per shift, and complete REDCap questionnaires plus researcher-measured limb circumferences at baseline and day two for each period. The study will also conduct semi-structured interviews and daily logs to capture comfort, usability, standing hours, pain/fatigue scores, and barriers to device use, with qualitative data coded in NVivo. Findings are intended to estimate effect sizes for a larger trial and inform occupational health strategies and guidelines to reduce venous disease and leg swelling in standing healthcare staff in Aotearoa New Zealand
Interventions
All participants will undergo each intervention in a random order. Interventions will be undertaken for two consecutive days, with a minimum of one day washout in-between. Considering the shift-work and clinical duties that participants will have, this washout period will most likely be a week. Participants will record use in a log book that includes estimated standing time.
Intervention 1: Jobst Class II knee-length graduated compression stockings (23-32 mmHg), worn for the entire shift two co
All participants will undergo each intervention in a random order. Interventions will be undertaken for two consecutive days, with a minimum of one day washout in-between. Considering the shift-work and clinical duties that participants will have, this washout period will most likely be a week. Participants will record use in a log book that includes estimated standing time. Intervention 1: Jobst Class II knee-length graduated compression stockings (23-32 mmHg), worn for the entire shift two consecutive working days. A vascular clincal nurse speciallist will measure the participants for stockings and show them how to don, doff, and care for these. Intervention 2: RecoverySystems portable calf Intermittent pneumatic cuff (45 mmH), used for at least 15 minutes twice per shift two consectutive working days (can be seated, standing, or supine). A researcher will demonstrate their use, and provide an informative brochure.
Sponsors
University of Otago, Department of Surgery and Critical Care
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Employed clinical staff of Dunedin Hospital aged equal to or older than 18 years. • Theatre or ward position requiring standing at least 3 hours continuously per shift. • Self-reported feelings of leg swelling • For biologically female participants: Participants must have either regular, predictable menstrual cycles (eumenorrhea: cycle length 21–35 days, consistent from month to month) or be postmenopausal (defined as no menstrual periods for at least 12 consecutive months)
Exclusion criteria
• Active lower-limb ulceration or dermatitis. • Known peripheral arterial disease (ABPI <0.8). • Pregnancy. • Contraindications to compression (acute DVT, severe heart failure). • Wearing compression stockings for the majority of shifts
Outcome results
None listed