Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04800744
Other study ID # STUDY20100091
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A