Therapeutic strategies for chronic wound infection.
Yi-Fan Liu, Peng-Wen Ni, Yao Huang...
https://pubmed.ncbi.nlm.nih.gov/34315658/Actively Recruiting
Led by Singapore General Hospital · Updated on 2026-07-28
40
Participants Needed
2
Research Sites
26 weeks
Total Duration
This clinical trial is investigating whether inhalation aromatherapy can reduce anxiety and pain during conservative sharp wound debridement CSWD in patients with venous leg ulcers. The study also aims to assess how feasible and acceptable it is to use aromatherapy in a clinical setting. Researchers want to understand if aromatherapy affects anxiety levels measured by the State-Trait Anxiety Inventory and pain intensity during the wound care procedure. Participants are randomly assigned to one of two groups. One group receives inhalation aromatherapy using a personal nasal stick infused with a blend of Asian aromatic plant extracts selected for their potential anxiety and pain-relieving properties. They inhale this stick starting five minutes before the procedure and continue throughout the CSWD for up to ten minutes. The other group receives a placebo inhalation stick containing jojoba oil with no known anxiolytic effects, following the same inhalation routine. Each participant uses their own inhalation stick across all visits. During the study, participants attend clinic visits for wound debridement as part of their standard care. They complete anxiety questionnaires before and after the procedure and rate their pain intensity during treatment. Researchers monitor participation and retention rates over a 12-month data collection period, with visits scheduled on Day 1, Day 8, and Day 15. They also track adherence to the study protocol and collect feedback on treatment satisfaction and acceptability to better understand the practical use of inhalation aromatherapy.
CONDITIONS
Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:
N
Nanthakumahrie Gunasegaran
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Singapore General Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 3 clinic visits over 15 days
Duration - 15 days
Participants receive either inhalation aromatherapy or placebo inhalation sticks during conservative sharp wound debridement procedures.
3 clinic visits on Day 1, Day 8, and Day 15
Duration - Up to 12 months data collection
Researchers assess anxiety and pain levels, treatment satisfaction, and adherence throughout the study period.
Periodic assessments during clinic visits
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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