Postoperative PainNCT07771205
Aromatherapy and Its Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience
A study testing Aromatherapy and Unscented Pod in people with Postoperative Pain and Preoperative Anxiety, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Preoperative Anxiety, Patient Experience
- What is being tested?
- Aromatherapy and Unscented Pod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to speak, read, understand, and write in English or Spanish
- Undergoing a surgical procedure under general anesthesia
- Able to provide informed consent independently
Who cannot join
- Cataract and other ocular surgeries
- Allergies to aromatherapy ingredients
- Chronic pain management
- Olfactory deficits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente Stockton Ambulatory Surgery Unit
Stockton, California, 95210
Kristie L Silva, MSN, 209-476-3002, Kristie.L.Taylor@kp.org
Kristie L Silva, MSN
About this study
Official title: Aromatherapy and Its Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience: A Randomized Control Trial
Aromatherapy's Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience
Introduction:
Read more
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
- Being tested
- Aromatherapy, Unscented Pod
- Keywords
- Preoperative anxiety, surgery, anxiety, pain, postoperative pain, ambulatory, experience, patient experience, aromatherapy, complementary alternative medicine, nurse-led
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
An aromatherapy pod with the blend of Lavendar and Sweet Orange, which has been identified as aiding with stress, pain, and anxiety.
Unscented PodOther
An unscented "aromatherapy" pod that looks identical to the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Scented Aromatherapy Pod | Active comparator | Aromatherapy Pod Receives: Other: Aromatherapy |
| Unscented Aromatherapy Pod | Placebo comparator | Unscented Pod Receives: Other: Unscented Pod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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".
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start7 Jul 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with a blinded placebo and intervention group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771205
- Sponsor's protocol ID
- 2373248-1
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: HIPAA
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy and Its Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07771205
- Acronym / sponsor ID
- 2373248-1
- Conditions
- Postoperative Pain, Preoperative Anxiety, Patient Experience
- Keywords
- Preoperative anxiety, surgery, anxiety, pain, postoperative pain, ambulatory, experience, patient experience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with a blinded placebo and intervention group
| Arm | Type | Receives |
|---|---|---|
| Scented Aromatherapy Pod | Active comparator | Other: AromatherapyAromatherapy Pod |
| Unscented Aromatherapy Pod | Placebo comparator | Other: Unscented PodUnscented Pod |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to speak, read, understand, and write in English or Spanish
- Undergoing a surgical procedure under general anesthesia
- Able to provide informed consent independently
Key exclusion criteria (4 listed)
- Cataract and other ocular surgeries
- Allergies to aromatherapy ingredients
- Chronic pain management
- Olfactory deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyAn aromatherapy pod with the blend of Lavendar and Sweet Orange, which has been identified as aiding with stress, pain, and anxiety. | Other | Scented Aromatherapy Pod |
| Unscented PodAn unscented "aromatherapy" pod that looks identical to the active intervention. | Other | Unscented Aromatherapy Pod |
Primary outcome
Preoperative Anxiety
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.
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.
Verbalized Postoperative Pain
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.
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.
Patient Experience
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.
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).
Non-verbal Postoperative Pain
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.
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Improving Breast Surgery Outcomes Through Alternative Therapy: A Systematic ReviewLink provided by the sponsor.
- The Effect of Aromatherapy with Citrus aurantium Aroma on Pain after Orthopedic Surgery: A Randomized Clinical TrialLink provided by the sponsor.
- Statistical power analyses using G\*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 1149-1160Link provided by the sponsor.
- The Effect of Aromatherapy on Pain and Anxiety Levels Before Breast Biopsy: A Randomized Controlled TrialLink provided by the sponsor.
- Implementation of Aromatherapy, a Nonpharmacological Intervention, to Reduce Anxiety During the Preoperative PeriodLink provided by the sponsor.
- 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 trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. HIPAA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaiser Permanente Stockton Ambulatory Surgery Unit
Stockton, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Unscented Pod in people with Postoperative Pain and Preoperative Anxiety, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety (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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.