Aromatherapy for Improving Post-Surgical Quality of Life

Quality of Life Clinical Trial

Official title:

Aromatherapy for Improving Post-Surgical Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800744
• Other study ID #: STUDY20100091
• Status: Completed
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: May 17, 2023

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Postoperative
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UPMC Shadyside Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Beekley Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative emotional distress related to depression	Post-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form. There are 8 questions about how the participant many 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 through one month post-operative
Secondary	Post-operative pain rating using the Visual Analog Scale (VAS)	Post-operative pain ratings will be measured by the assessment of the participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10.The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome.	Day of surgery through one month post-operative
Secondary	Post-operative pain rating using the Pain Catastrophizing Scale	Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 13 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 52. Higher scores present a worse outcome.	Day of surgery through one month post-operative
Secondary	Post-operative consequences of pain	Post-operative consequences of pain will be measured by the assessment of the participant's answers to the PROMIS Pain Interference - Short Form 6b. This assessment measures the self-reported consequences of pain on relevant aspects of the participant's physical and social life in the past 7 days. The scale for interference of pain with each activity is from 1, not at all in the past 7 days, to 5, very much in the past 7 days. The overall score can range from 6 to 30. Higher scores present a worse outcome.	Day of surgery through one month post-operative
Secondary	Opioid Consumption	Investigate the efficacy of aromatherapy in reducing perioperative opioid consumption in opioid naive subjects undergoing unilateral total hip replacement surgery and those undergoing unilateral or bilateral mastectomy.	Day of surgery through one month post-operative
Secondary	Incidence of post-operative nausea and vomiting	Evaluate the incidence of post-operative nausea and vomiting.	Day of surgery through one month post-operative
Secondary	Incidence of post-operative complications	Investigate the incidence of post-operative complications in subjects who received the standard protocol for total hip replacement surgery or the standard protocol for mastectomies versus subjects who received the standard protocol and aromatherapy.	Day of surgery through one month post-operative
Secondary	Functional Recovery	Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1).These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and well-being). Overall score can range from 12 to 53. Higher scores present a better outcome.	Day of surgery through one month post-operative
Secondary	Hospital Readmissions	Determine the number of patients readmitted to the hospital.	Day of surgery through one month post-operative
Secondary	Length of Hospital Stay	Evaluate time to hospital discharge.	Day of surgery through one month post-operative