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Aromatherapy for Improving Post-Surgical Quality of Life

NCT04800744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-05-31

No results posted yet for this study

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

Interventions

OTHER

Lavender peppermint elequil aromatab

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

OTHER

Sweet almond oil elequil aromatab

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

Sponsors & Collaborators

  • Beekley Medical

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Jacques E Chelly, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2023-04-17
Completion
2023-05-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800744 on ClinicalTrials.gov