Aromatherapy and Its Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience

NCT07771205 | Recruiting

• 1 other identifier: 2373248-1
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Preoperative Anxiety; Patient Experience

Keywords

Preoperative anxiety; surgery; anxiety; pain; postoperative pain; ambulatory; experience; patient experience; aromatherapy; complementary alternative medicine; nurse-led

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

• 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.

  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.

• 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).

  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.

• 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".

  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.

Study Arms (2)

Scented Aromatherapy Pod

ACTIVE COMPARATOR

Aromatherapy Pod

Other: Aromatherapy

Unscented Aromatherapy Pod

PLACEBO COMPARATOR

Unscented Pod

Other: Unscented Pod

Interventions

Aromatherapy OTHER

An aromatherapy pod with the blend of Lavendar and Sweet Orange, which has been identified as aiding with stress, pain, and anxiety.

Scented Aromatherapy Pod

Unscented Pod OTHER

An unscented "aromatherapy" pod that looks identical to the active intervention.

Unscented Aromatherapy Pod

Eligibility Criteria

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

You may qualify if:

• Able to speak, read, understand, and write in English or Spanish
• Undergoing a surgical procedure under general anesthesia
• Able to provide informed consent independently

You may not qualify if:

• Cataract and other ocular surgeries
• Allergies to aromatherapy ingredients
• Chronic pain management
• Olfactory deficits

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Stockton Ambulatory Surgery Unit

Stockton, California, 95210, United States

RECRUITING

Related Links

• Improving Breast Surgery Outcomes Through Alternative Therapy: A Systematic Review
• The Effect of Aromatherapy with Citrus aurantium Aroma on Pain after Orthopedic Surgery: A Randomized Clinical Trial
• Statistical power analyses using G\*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 1149-1160
• The Effect of Aromatherapy on Pain and Anxiety Levels Before Breast Biopsy: A Randomized Controlled Trial
• Implementation of Aromatherapy, a Nonpharmacological Intervention, to Reduce Anxiety During the Preoperative Period
• The effect of lemon inhalation aromatherapy on pain, nausea, as well as vomiting and neurovascular assessment in patients for lower extremity fracture surgery: a randomized trial
• Development and psychometric validity of the perioperative anxiety scale-7 (PAS-7)

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Pain

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with a blinded placebo and intervention group

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: August 18, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)