Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in Anxiety level before and each individual day after surgery.
研究概览
简要总结
The purpose of this pilot randomized controlled trial is to investigate the effects of aromatherapy on postoperative anxiety and pain in total knee replacement patients. The primary research questions are:
Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo?
Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo?
Participants will be assigned to one of the following groups at random:
- Intervention: Aromatherapy with the lavender-peppermint scent
- Control: Aromatherapy with the almond oil scent
Participants will also be asked to complete pre- and post-operative questionnaires.
Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety and/or pain.
详细描述
Preoperative depression, anxiety, and catastrophizing have all been linked to an increase in postoperative pain and opiate use. Although aromatherapy, specifically lavender, may lower anxiety, no placebo-controlled trial has been undertaken to establish Aromatherapy's therapeutic promise for anxiety after total knee replacement. Although peppermint has been demonstrated to reduce nausea and vomiting, it has not been tested in this population for post-operative nausea and vomiting (PONV). The purpose of this pilot randomized controlled study is to determine the effectiveness of Lavender-Peppermint in reducing post-operative anxiety and discomfort in patients following unilateral primary knee replacement surgery.
The primary research questions are:
Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo?
Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo?
Participants will be assigned to one of the following groups at random:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Research staff (i.e. research assistants, coordinators, etc.)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and ≤ 80
- •Scheduled to undergo primary, unilateral knee replacement surgery
- •Willing and able to provide informed consent
- •Willing and able to complete follow-up procedures
- •Intact olfactory function
- •Score 19 or greater on the PROMIS Anxiety Shortform 8A
排除标准
- •Score <19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
- •Current major anxiety or depression
- •Currently taking medications to treat anxiety
- •Impaired sense of smell
- •History of chronic pain with opioid use for greater than 3 months
- •History of Drug or Alcohol abuse
- •History of fibromyalgia
- •History of G6PD deficiency
- •Plant or tree nut allergy
- •Severe allergy to Opioids, NSAIDS or local anesthetics (such as anaphylaxis)
- •Severe liver disease, renal insufficiency (with inability to take acetaminophen or NSAIDS)
- •Non-English Speaking
- •Surgery requiring a hospitalization of greater than 3 days
- •Patient refusal
- •Current cardiac fibrillation
- •Chronic opioid user (>3 months)
- •Contraindication to neuraxial anesthesia
结局指标
主要结局
Changes in Anxiety level before and each individual day after surgery.
时间窗: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
To assess the change in participants' anxiety level before and each individual day after surgery. Measured using the State Anxiety Inventory. State anxiety was scored on the following scale: 1. = not at all 2. = somewhat 3. = moderately so 4. = very much so Trait anxiety was scored on the following scale: 1. almost never 2. sometimes 3. often 4. almost always with 1 being the lowest score and 4 being the highest score.
Difference in anxiety level before and after surgery
时间窗: Measured pre-operatively and on post-operative day (POD) 7
To assess participants' preoperative (cumulative 7 days before surgery) and postoperative (cumulative 7 days after surgery) anxiety. Measured using the PROMIS anxiety short form 8a Version 1.0. Scored on the following scale: 1. = never 2. = rarely 3. = sometimes 4. = often 5. = always with 1 being the lowest score and 5 being the highest scores.
The average pain score after surgery
时间窗: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
To assess the average pain score of participants after surgery. Measured using the numerical rating scale (NRS). Measured on a 11-point numeric scale from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
次要结局
- Difference in depression level before and after surgery(Measured pre-operatively and on post-operative day (POD) 7)
- Average score on pain catastrophizing(Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7)
- Average score on pain interference(Measured pre-operatively and on post-operative day (POD) 7)
- Average post-operative opioid consumption(Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7)
- Presence of post-operative nausea(Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7)
- Presence of post-operative vomiting(Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7)
- Incidences of post-operative complications(Measured at post-anesthesia care unit (PACU) up to post operative day 7)
- To assess the severity of opioid-related symptom distress(Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7)
- To assess participants' satisfaction with the aromatherapy(Measured at post operative day 7)
- Aromatab Adherence(Measured on post operative day (POD) 1, POD2, POD3.)
- Hospital Length of Stay(Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time)
- Bang Blinding Index(Measured on postoperative day 7)