Effect of Aromatherapy Using Lavender Essential Oil on Pain and Anxiety After C-section: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-operative pain level
研究概览
简要总结
A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.
The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women who gave birth by cesarean section under spinal anesthesia in the obstetrics and gynecology department at the Ben Arous regional hospital who met the following criteria were included in this study:
- •Age between 18 and 45 years old
- •Term of pregnancy at the time of delivery ≥ 37 weeks of Gestation.
- •A minimum level of primary education as a prerequisite to answer the questions (in particular the STAI items).
- •Classified ASA 1 or 2 of the American Society of Anesthesiology (ASA) classification.
- •Having no history of cancer or chronic pain.
- •Free from any psychiatric pathology.
- •And having not presented any intra- or post-operative complications.
排除标准
- •The investigators excluded patients in our study:
- •Having given birth to a stillborn or a suffering newborn requiring transfer to neonatal intensive care.
- •Having received painkillers in the post-operative period.
- •Having olfactory disorders.
- •Having a substance abuse problem.
- •Having a known allergy to lavender or other aromatic plants.
- •who did not agree to participate in the study or who did not continue all stages of the trial.
结局指标
主要结局
Post-operative pain level
时间窗: two to twelve hours after surgery
the investigator evaluated the Post-operative pain level using Visual analogue scale( patient at rest and after ambulation). The score ranges from 0 (no pain at all) to 10 (the worst imaginable pain). the higher the score is, the worst the outcome is.
Post-operative anxiety level
时间窗: two to twelve hours after surgery
the investigator evaluated the Post-operative anxiety level using the " State Trait Anxiety Inventory (STAI)forme Y ". The score ranges from 20 to 80. Higher scores are associated with higher levels of anxiety (worse outcome)
次要结局
- Heart Rate (HR)(two to twelve hours after surgery)
- Systolic Blood Pressure (SBP)(two to twelve hours after surgery)
- Diastolic Blood Pressure (DBP)(two to twelve hours after surgery)
- Pulsatile Oxygen Saturation(two to twelve hours after surgery)
- Respiratory Rate (RR)(two to twelve hours after surgery)
研究者
Nesrine Souayeh
Associated Professor
University Tunis El Manar