Aromatherapy for Improving Post-Surgical Quality of Life
Condition: Quality of Life; Anxiety Postoperative
Study type: Interventional

Summary: 
      Pre-operative anxiety is a very common condition that plagues many patients prior to
      undergoing surgery. Anxious patients are most frequently treated with sedatives in the
      perioperative period, which can have a negative impact on post-operative recovery, especially
      when combined with narcotic pain medications. Pre-operative anxiety, depression and
      catastrophizing have been shown to be factors leading to an increase of up to 50% of
      postoperative pain and opioid requirement. Therefore, the control of mood disorders prior to
      surgery may help with the perioperative pain management and postoperative opioid requirement.
      The use of essential oils in aromatherapy have long been associated with psychological
      wellness, and anecdotal reports suggest that aromatherapy, specifically lavender scent, may
      reduce anxiety. This study will assess the role of the elequil aromatab #373
      Lavender-Peppermint in improving post-surgical quality of life in patients undergoing
      unilateral hip replacement surgery and in patients undergoing unilateral or bilateral
      mastectomy. Additionally, this study will follow subjects through their perioperative course
      to measure to what degree the aromatherapy intervention helps to reduce instances of
      post-operative nausea and vomiting (PONV) and opioid requirement following surgery.
    

Detailed description: 
      Potential subjects will be recruited from the office of orthopedic surgeon Dr. Michael
      O'Malley, Dr. Frank Plate or Dr. Brian Klatt, as well as the office of plastic surgeon Dr.
      Carolyn De La Cruz and will be provided with a recruitment flier. The patient will have the
      option of contacting our research team to discuss the study further, or, if they express
      interest in the study to the surgeon's office, their name will be given to us by the
      surgeon's office staff. If our research team is contacted, or if we reach out based upon the
      list of interested potential subjects, we will discuss the study over the telephone with the
      patient with the understanding that they will sign the informed consent with Dr. Chelly or a
      co-investigator on the day of surgery in the pre-operative area.

      Subjects that meet inclusion criteria, self report anxiety, and provide informed consent will
      complete the PROMIS Emotional Distress - Anxiety - Short Form 8a before completing any other
      questionnaires. If the subject scores ≥19 on the PROMIS Emotional Distress - Anxiety - Short
      Form 8a they will be enrolled in the study. However, if the subject scores <19 on the PROMIS
      Emotional Distress - Anxiety - Short Form 8a they will be considered a screen fail and
      excluded from participation in the study. Once the subject is enrolled, they will be asked to
      complete the PROMIS Emotional Distress-Depression-Short Form, the PROMIS Pain Interference -
      Short Form 6b and the Pain Catastrophizing Scale. After completion of these forms, subjects
      will be equally randomized to either the active comparator aromatab (sweet almond oil) or
      treatment aromatab (lavendar peppermint). Study coordinators, Co-Is, and subjects will be
      blinded.

      The aromatab will be placed on the patient's clothing at least one hour prior to surgery
      while the patient is in same day admission. After surgery, the subject will be assessed for
      post-operative nausea, pain scores, and pain medication requirement in the PACU and then
      assessed daily until discharge. At the 12-hour mark, the subject will receive another new
      patch that is consistent with their randomization arm. They will apply a new patch every 12
      hours for the duration of the 72-hour treatment window with the last patch being placed at 60
      hrs post-operative.

      Upon discharge, subjects will receive patches for the remaining 72-hour treatment window. At
      this time, subjects will be asked an overall satisfaction questionnaire measured on a scale
      to 0-10 (0=lowest satisfaction and 10=highest satisfaction).

      The subjects will be contacted via Redcap 24 hours, 48 hours and 7 days post-operative and
      asked to complete PROMIS Emotional Distress - Anxiety - Short Form 8a, the PROMIS Emotional
      Distress-Depression-Short Form , the PROMIS Pain Interference - Short Form 6b and the Pain
      Catastrophizing Scale. In addition to this, the subject will be asked to report in a Redcap
      survey VAS pain score, incidence of nausea and vomiting, and their opioid consumption at 24
      hrs, 48 hrs and 7 days post-operative. The subjects will also receive reminders via Redcap at
      12hrs, 24hrs, 36hrs, 48hrs, and 60 hrs to change their patch, and will be asked to document
      in Redcap the time this is complete.

      One month following the surgery the subject will be contacted via Redcap to determine their
      level of pain (VAS), opioid consumption, incidence of nausea and vomiting, functional
      recovery using SF12, and the PROMIS Emotional Distress - Anxiety - Short Form 8a, the PROMIS
      Emotional Distress-Depression-Short Form, PROMIS Pain Interference - Short Form 6b and Pain
      Catastrophizing Scale. Subjects who are contacted via Redcap to complete follow-up
      questionnaires and do not complete them on the day they are assigned will be contacted via
      phone for reminder.
    

Intervention name(s): Lavender peppermint elequil aromatab; Sweet almond oil elequil aromatab
Intervention type(s): Other; Other
Intervention description(s): Lavender peppermint elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window.; Sweet almond oil elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window.
Other intervention name(s): treatment aromatab; active comparator aromatab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center Prospective, Randomized, Double-blind, Active comparator trial involving patients undergoing unilateral hip replacement and patients undergoing unilateral or bilateral mastectomy that score ≥19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: aromatherapy; unilateral hip replacement surgery; post-surgical quality of life; mastectomy