Aromatherapy and Its Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Permanente
About this trial
Aromatherapy's Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience
Introduction:
Surgery often results in increased levels of anxiety and postoperative pain. Postoperative pain relief is typically treated with opioids. However, evidence shows that treatment with opioids alone is often insufficient to provide adequate levels of pain relief and can contribute to the growing opioid crisis. Alternative pain management strategies that combine narcotic medication with complementary therapies can improve comfort as well as decrease preoperative anxiety. Aromatherapy is an evidence-based complementary therapy used to decrease preoperative anxiety and postoperative pain that has been underutilized in ambulatory surgical centers. This study aimed to evaluate the impact Aromatherapy has as an anxiety and pain management strategy. Subsequently, evidence also supports that improving the patient experience can lead to better surgical outcomes.
Study Aim:
This study will examine the effect that aromatherapy has on preoperative anxiety, postoperative pain and patient experience
Study Question(s):
In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect preoperative anxiety?
In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect postoperative pain?
In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect patient experience?
Study Method: Prospective Experimental Randomized Control Clinical Trial
Study Duration: 18 months
Study Process: The participants will be recruited through their Pre-surgery interview, at which time a brief explanation will be given on aromatherapy, its potential to reduce preoperative anxiety and postoperative pain, and increase the patient experience. The study design and protocol will also be described. Should the participants elect to participate in this study, they will be randomly assigned using a computer program. Upon arrival for surgery, informed consent will be obtained. Anxiety and pain will be assessed for pre- and post- intervention and just before transferring to the operating room (OR). Upon arrival to the Post-Anesthesia Care Unit (PACU), pain will be assessed in 15-minute intervals until discharge. Anxiety will be reassessed at discharge. Experience will be assessed 2 weeks after discharge.
Data Analysis:
A one-way Multivariate Analysis of Variance (MANOVA) will be used to assess the impact of aromatherapy on pain, anxiety, and satisfaction.
Conclusions:
This study aims to add to the body of knowledge of how the incorporation of aromatherapy can impact patient outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to speak, read, understand, and write in English or Spanish
Undergoing a surgical procedure under general anesthesia
Able to provide informed consent independently
Disqualifiers
Cataract and other ocular surgeries
Allergies to aromatherapy ingredients
Chronic pain management
Olfactory deficits
Trial design
Design model
Parallel
Treatments tested in this trial
Aromatherapy
Other interventionAn aromatherapy pod with the blend of Lavendar and Sweet Orange, which has been identified as aiding with stress, pain, and anxiety.
Unscented Pod
Other interventionAn unscented "aromatherapy" pod that looks identical to the active intervention.
Treatment groups
286 Participants
are divided into 2 treatment groupsGroup A: Scented Aromatherapy PodActive comparator 1 intervention
Group B: Unscented Aromatherapy PodPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Preoperative Anxiety
Assessed using the Preoperative Anxiety Scale-7. This is a 7 question 5-point Likert scale with the values of 0 to 4, 0 being no anxiety and 4 being the highest anxiety. There are a possible total of 28 points, which would be assessed as the highest level of anxiety measurement possible. The lowest possible is 0.
Time frame
Prior to the intervention, the participant will assess their baseline anxiety using the Preoperative Anxiety Scale-7, re-evaluated prior to transfer to the OR after intervention is applied, and again at discharge. All on Day 1, date of surgery.2
Verbalized Postoperative Pain
Measured using the Wong-Baker Faces Pain Scale (WB). The WB scale has a low-end value of 0, indicating no pain, and a high-end value of 10, indicating the most pain. WB can be measured in whole numbers from 0-10.
Time frame
Assessed upon arrival to preop and prior to intervention, for a baseline. Reassessment after intervention and prior to transfer to OR, upon arrival to PACU, 15-minute intervals until ready to discharge, and at discharge. All on Day 1, date of surgery.3
Patient Experience
Patients are asked to evaluate their experience using study-specific designed 5-point Likert scale consisting of 7-8 questions. Questions asked are: "How well was aromatherapy explained?", "How would you rate your overall aromatherapy experience?", "How well did aromatherapy help you to relax before surgery?", How well did aromatherapy help your pain before surgery?" (if pain was present at baseline assessment), "How well did aromatherapy help your pain after surgery?", "How likely are you to continue to use aromatherapy for anxiety management at home?", and "How likely are you to continue to use aromatherapy for anxiety management at home?" The low-end value is 1 and the high-end value is 5. Question 5 will only be asked if preoperative pain was present. There is a minimum of 8 and maximum of 40 for 8 questions (preop pain present), and a minimum of 7 and maximum of 35 for 7 questions (no preop pain present).
Time frame
1 week after date of surgery. The questionnaire should take 5- 10 minutes to complete. The patient is called at home by a study nurse.4
Non-verbal Postoperative Pain
Checklist of Non-verbal Pain Indicators (CNPI) scale. The CNPI scale has a low-end value of 0, indicating no pain, and a high-end value of 6, indicating the most pain. This scale assesses for non-verbal characteristics that could identify when pain is present when the patient cannot articulate their pain through WB scale. One point is awarded for each behavior observed with a possible score of 0-6. This scale can also be assessed "at rest" or "with activity".
Time frame
Assessed upon arrival to preop and prior to intervention, for a baseline. Reassessment after intervention and prior to transfer to OR, upon arrival to PACU, 15-minute intervals until ready to discharge, and at discharge. All on Day 1, date of surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov