Efficacy of aromatherapy with Citrus aurantium essential oil as compared to placebo in reducing pain level among the upper limb fracture post-operative orthopedic patients: A double-blinded randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of aromatherapy with Citrus aurantium essential oil as compared to placebo in reducing pain levels among upper limb fracture post-operative orthopedic patients.
研究概览
简要总结
This study is a double-blinded randomized trial to assess the efficacy of Citrus aurantium essential oil as compared to placebo (distilled water) in reducing pain level among the upper limb fracture post-operative orthopedic patients. Patients who met the inclusion criteria were enrolled after an allergy test using convenient sampling with randomization. The procedure was performed at 24th, 48th and 72nd hour post surgery. Initial data for every participant was collected before the beginning of the procedure: demographic data and VAS score. Both the researcher and participant were blinded in the study to avoid bias and to ensure reliability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who will undergo upper limb fracture orthopedic surgery.
- •Patients who will be fully alert after recovering from anesthesia.
- •Patients who will be able to self-report a normal sense of smell.
- •Patients who will be able to visualize VAS for pain intensity.
- •Patients whose VAS is less than or equal to 7 (mild to moderate) Patients who have not received analgesic within 2 hours of aromatherapy administration.
- •Patients with negative allergy test.
- •Patients between 18 and 65 years of age.
排除标准
- •Patients having postoperative complications (such as hemorrhage and hematoma) Patients who need oxygen therapy.
- •Patients who have epidural analgesia (nerve block) Patients with nasal blocks.
- •Patients who have a known history of allergy to any essential oils.
结局指标
主要结局
To evaluate the efficacy of aromatherapy with Citrus aurantium essential oil as compared to placebo in reducing pain levels among upper limb fracture post-operative orthopedic patients.
时间窗: At 24, 48 and 72 hours post surgery.
次要结局
- Not Applicable(Not applicable)
研究者
Chumdeno Tungoe
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006