The Effectiveness and Acceptability of Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participation Rate
研究概览
简要总结
The goal of this pilot clinical trial is to learn if inhalation aromatherapy works to reduce anxiety and pain in patients with venous leg ulcers undergoing conservative sharp wound debridement (CSWD). It will also learn about the feasibility of implementing this intervention in clinical practice. The main questions it aims to answer are:
Does inhalation aromatherapy reduce anxiety levels during CSWD procedures, as measured by STAI-S scores? Does inhalation aromatherapy reduce pain intensity during CSWD procedures? Is inhalation aromatherapy feasible and acceptable to implement in a clinical setting? What are the protocol adherence rates and potential areas of missing data?
Researchers will compare inhalation aromatherapy using Asian essential oil extracts to standard care to see if aromatherapy works to reduce anxiety and pain during wound debridement.
Participants will:
Receive either inhalation aromatherapy or standard care during their CSWD procedure Complete State-Trait Anxiety Inventory (STAI-S) questionnaires before and after the procedure Rate their pain intensity using visual analog scales during the debridement Provide feedback on treatment satisfaction and acceptability Attend clinic visits for wound debridement as part of their standard care
This pilot study hypothesizes that inhalation aromatherapy is feasible and acceptable to implement in a clinical setting and may be associated with differences in anxiety and pain intensity during CSWD, compared to standard care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants will be allocated to either the Inhalation Aromatherapy intervention group or the Inhalation Placebo control group in a 1:1 ratio using randomly permuted block randomization, ensuring balanced allocation throughout the recruitment period. The randomization sequence will be generated by an independent member not involved in recruitment, intervention delivery, or outcome assessment, keeping the allocation process free from investigator influence. Upon confirmation of eligibility and informed consent, each participant will be assigned according to the pre-generated sequence. Allocation concealment will be maintained until the point of assignment, with block sizes kept undisclosed to further safeguard concealment. This rigorous process strengthens internal validity and supports a fair and unbiased comparison across the planned 40-participant sample. Unblinding will only occur after all data have been collected and locked.
入排标准
- 年龄范围
- 21 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥21 years old
- •Venous leg ulcers requiring conservative sharp wound debridement
排除标准
- •Known sensitivity or hypersensitivity to essential oils or any components in the Aromatherapy scent formulation
- •Allergic rhinitis, asthma, chronic lung disease or any disease that impairs the sense of smell
- •Airway hypersensitivity to fragrances, paint/gasoline fumes or turpentine
- •Using aromatherapy of any kind
- •Taking any anti-psychotic drugs
- •Incapable of providing verbal/written consent
- •On anti-anxiety medications
结局指标
主要结局
Participation Rate
时间窗: Throughout the 12-month data collection period from October 2026 to September 2027.
The number of recruited patients divided by total eligible patients approached, expressed as a percentage.
Retention rate
时间窗: The number of participants completed 3rd clinic visit/15th day, across the 12-month data collection period from October 2026 to September 2027. Clinic visit 1 - 1st Day- week 1, Clinic visit 2 -8th Day- week 2, Clinic visit 3- 15th Day- week 3.
The number of patients remaining divided by total patients who consented, expressed as a percentage.
Percentage Change in State Anxiety Level During Conservative Sharp Wound Debridement
时间窗: Completed at 3rd clinic visit/15th day, across the 12-month data collection period from October 2026 to September 2027. Clinic visit 1 - 1st Day- week 1, Clinic visit 2 -8th Day- week 2, Clinic visit 3- 15th Day- week 3
Percentage change in STAI-S score at T1 (2nd clinic visit/2nd week/8th day): (pre-CSWD STAI-S minus post-CSWD STAI-S) divided by pre-CSWD STAI-S, multiplied by 100. Unit: percentage change on STAI-S scale. Percentage change in STAI-S score at T2 (3rd clinic visit/3rd week/15th Day), calculated. Unit: percentage change on STAI-S scale. Reported separately to assess sustainability of effect over time.
次要结局
- Protocol Adherence Rate(Assessed throughout the 12-month data collection period from October 2026 to September 2027.)
- Attrition Rate and Extent of Missing Data(Assessed through the 12-month data collection period from October 2026 to September 2027. Clinic visit 1 - 1st Day- week 1, Clinic visit 2 -8th Day- week 2, Clinic visit 3- 15th Day- week 3.)
- Change in Pain Intensity During Conservative Sharp Wound Debridement(Change in pain intensity measured pre- and post-CSWD at T1 (2nd Clinic visit/8th Day) and T2 (3rd Clinic visit/15th Day) to assess sustainability, using (VAS), scored 0-100mm. Clinic visit 2 -8th Day- week 2, Clinic visit 3 -15th Day -week3.)