Clinical trial NCT04800744: Aromatherapy for Improving Post-Surgical Quality of Life
Official title: Aromatherapy for Improving Post-Surgical Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Anxiety Postoperative
Keywords: aromatherapy
unilateral hip replacement surgery
post-surgical quality of life
mastectomy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Beekley Medical
First posted: 2021-03-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 and ≤ 80
* Scheduled to undergo unilateral hip replacement surgery or scheduled to undergo unilateral or bilateral mastectomy
* Self-reported anxiety related to upcoming surgery
* Subject is willing and able to provide informed consent
* Subject is willing and able to complete follow-up procedures

Exclusion Criteria:

* Score \<19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
* History of major anxiety or depression
* History of opioid use disorder or alcohol abuse
* History of atrial fibrillation
* History of fibromyalgia
* History of G6PD deficiency
* Plant or tree nut allergy
* Surgery requiring a hospitalization of greater than 3 days
* Patient refusal

Primary outcomes:
measure: Change in post-operative anxiety
timeFrame: Day of surgery versus 7 days post-operative
Secondary outcomes:
measure: Post-operative emotional distress related to depression
timeFrame: Day of surgery through one month post-operative
measure: Post-operative pain rating using the Visual Analog Scale (VAS)
timeFrame: Day of surgery through one month post-operative
measure: Post-operative pain rating using the Pain Catastrophizing Scale
timeFrame: Day of surgery through one month post-operative
measure: Post-operative consequences of pain
timeFrame: Day of surgery through one month post-operative
measure: Opioid Consumption
timeFrame: Day of surgery through one month post-operative
measure: Incidence of post-operative nausea and vomiting
timeFrame: Day of surgery through one month post-operative
measure: Incidence of post-operative complications
timeFrame: Day of surgery through one month post-operative
measure: Functional Recovery
timeFrame: Day of surgery through one month post-operative
measure: Hospital Readmissions
timeFrame: Day of surgery through one month post-operative
measure: Length of Hospital Stay
timeFrame: Day of surgery through one month post-operative
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jacques E Chelly, MD
role: PRINCIPAL_INVESTIGATOR
References: