Aromatherapy for Improving Post-Surgical Quality of Life

NCT04800744 | Completed

• 1 other identifier: STUDY20100091
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Anxiety Postoperative

Keywords

aromatherapy; unilateral hip replacement surgery; post-surgical quality of life; mastectomy

Outcome Measures

Primary Outcomes (1)

• Change in post-operative anxiety

  Demonstrate the effect of the elequil aromatab (Lavender-Peppermint) versus an active comparator (sweet almond oil) on participant's answers to the PROMIS Emotional Distress-Anxiety-Short Form 8a 7 days following surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.

  Day of surgery versus 7 days post-operative

Secondary Outcomes (10)

• Post-operative emotional distress related to depression

  Day of surgery through one month post-operative

• Post-operative pain rating using the Visual Analog Scale (VAS)

  Day of surgery through one month post-operative

• Post-operative pain rating using the Pain Catastrophizing Scale

  Day of surgery through one month post-operative

• Post-operative consequences of pain

  Day of surgery through one month post-operative

• Opioid Consumption

  Day of surgery through one month post-operative

Study Arms (2)

Lavender Peppermint Elequil Aromatab

EXPERIMENTAL

Participants will have a lavender peppermint elequil aromatab applied in same day admissions area at least 1 hour prior to the start of unilateral hip replacement. Thereafter, the participant will apply a new treatment elequil aromatab at 24 hrs, 36 hrs, 48 hrs, and 60 hrs post-operative.

Other: Lavender peppermint elequil aromatab

Sweet Almond Oil Elequil Aromatab

ACTIVE COMPARATOR

Participants will have a sweet almond oil active comparator elequil aromatab applied in same day admissions area at least 1 hour prior to the start of unilateral hip replacement. Thereafter, the participant will apply a new active comparator elequil aromatab at 24 hrs, 36 hrs, 48 hrs, and 60 hrs post-operative.

Other: Sweet almond oil elequil aromatab

Interventions

Lavender peppermint elequil aromatab OTHER

Lavender peppermint elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window.

Also known as: treatment aromatab

Lavender Peppermint Elequil Aromatab

Sweet almond oil elequil aromatab OTHER

Sweet almond oil elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window.

Also known as: active comparator aromatab

Sweet Almond Oil Elequil Aromatab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Beekley Medical: collaborator

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Study Officials

• Jacques E Chelly, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Perioperative Medicine

Model Details: 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

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 16, 2021
• Study Start: March 22, 2021
• Primary Completion: April 17, 2023
• Study Completion: May 17, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)