Quality of LifeNCT04800744
Aromatherapy for Improving Post-Surgical Quality of Life
A study testing Lavender peppermint elequil aromatab and Sweet almond oil elequil aromatab in people with Quality of Life and Anxiety Postoperative, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Anxiety Postoperative
- What is being tested?
- Lavender peppermint elequil aromatab and Sweet almond oil elequil aromatab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 17 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Plant or tree nut allergy
- Surgery requiring a hospitalization of greater than 3 days
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
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.
Read the detailed 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.
- Conditions
- Quality of Life, Anxiety Postoperative
- Being tested
- Lavender peppermint elequil aromatab, Sweet almond oil elequil aromatab
- Keywords
- aromatherapy, unilateral hip replacement surgery, post-surgical quality of life, mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender peppermint elequil aromatabOther
Also called treatment 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 aromatabOther
Also called active comparator aromatab
Sweet almond oil elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window.
| Study group | Role | What they receive |
|---|---|---|
| Lavender Peppermint Elequil Aromatab | Experimental | Participants will have a lavender peppermint elequil aromatab applied in same day admissions area at least 1 hour prior to the start of unilateral hip replacement. Thereafter, the participant will apply a new treatment elequil aromatab at 24 hrs, 36 hrs, 48 hrs, and 60 hrs post-operative. Receives: Other: Lavender peppermint elequil aromatab |
| Sweet Almond Oil Elequil Aromatab | Active comparator | Participants will have a sweet almond oil active comparator elequil aromatab applied in same day admissions area at least 1 hour prior to the start of unilateral hip replacement. Thereafter, the participant will apply a new active comparator elequil aromatab at 24 hrs, 36 hrs, 48 hrs, and 60 hrs post-operative. Receives: Other: Sweet almond oil elequil aromatab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery versus 7 days post-operative
Secondary outcomes (10)
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.
Measured: Day of surgery through one month post-operative
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.
Measured: Day of surgery through one month post-operative
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.
Measured: Day of surgery through one month post-operative
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.
Measured: Day of surgery through one month post-operative
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.
Measured: Day of surgery through one month post-operative
Incidence of post-operative nausea and vomiting
Evaluate the incidence of post-operative nausea and vomiting.
Measured: Day of surgery through one month post-operative
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.
Measured: Day of surgery through one month post-operative
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.
Measured: Day of surgery through one month post-operative
Hospital Readmissions
Determine the number of patients readmitted to the hospital.
Measured: Day of surgery through one month post-operative
Length of Hospital Stay
Evaluate time to hospital discharge.
Measured: Day of surgery through one month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start22 Mar 2021
- Primary completion17 Apr 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center Prospective, Randomized, Double-blind, Active comparator trial involving patients undergoing unilateral hip replacement and patients undergoing unilateral or bilateral mastectomy that score ≥19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Beekley Medical
- Responsible party
- Principal investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques E Chelly, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800744
- Sponsor's protocol ID
- STUDY20100091
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy for Improving Post-Surgical Quality of Life
- ClinicalTrials.gov ID
- NCT04800744
- Acronym / sponsor ID
- STUDY20100091
- Conditions
- Quality of Life, Anxiety Postoperative
- Keywords
- aromatherapy, unilateral hip replacement surgery, post-surgical quality of life, mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Beekley Medical
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 16 Mar 2021 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Single-center Prospective, Randomized, Double-blind, Active comparator trial involving patients undergoing unilateral hip replacement and patients undergoing unilateral or bilateral mastectomy that score ≥19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
| Arm | Type | Receives |
|---|---|---|
| Lavender Peppermint Elequil Aromatab | Experimental | Other: Lavender peppermint elequil aromatabParticipants will have a lavender peppermint elequil aromatab applied in same day admissions area at least 1 hour prior to the start of unilateral hip replacement. Thereafter, the participant will apply a new treatment elequil aromatab at 24 hrs, 36 hrs, 48 hrs, and 60 hrs post-operative. |
| Sweet Almond Oil Elequil Aromatab | Active comparator | Other: Sweet almond oil elequil aromatabParticipants will have a sweet almond oil active comparator elequil aromatab applied in same day admissions area at least 1 hour prior to the start of unilateral hip replacement. Thereafter, the participant will apply a new active comparator elequil aromatab at 24 hrs, 36 hrs, 48 hrs, and 60 hrs post-operative. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Lavender peppermint elequil aromatabAlso: treatment aromatabLavender peppermint elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window. | Other | Lavender Peppermint Elequil Aromatab |
| Sweet almond oil elequil aromatabAlso: active comparator aromatabSweet almond oil elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window. | Other | Sweet Almond Oil Elequil Aromatab |
Primary outcome
Change in post-operative anxiety
Time frame: Day of surgery versus 7 days post-operative
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.
10 secondary outcomes
Post-operative emotional distress related to depression
Time frame: Day of surgery through one month post-operative
Post-operative pain rating using the Visual Analog Scale (VAS)
Time frame: Day of surgery through one month post-operative
Post-operative pain rating using the Pain Catastrophizing Scale
Time frame: Day of surgery through one month post-operative
Post-operative consequences of pain
Time frame: Day of surgery through one month post-operative
Opioid Consumption
Time frame: Day of surgery through one month post-operative
Incidence of post-operative nausea and vomiting
Time frame: Day of surgery through one month post-operative
Incidence of post-operative complications
Time frame: Day of surgery through one month post-operative
Functional Recovery
Time frame: Day of surgery through one month post-operative
Hospital Readmissions
Time frame: Day of surgery through one month post-operative
Length of Hospital Stay
Time frame: Day of surgery through one month post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jacques E Chelly, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender peppermint elequil aromatab and Sweet almond oil elequil aromatab in people with Quality of Life and Anxiety Postoperative, run by University of Pittsburgh 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 29 Oct 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-operative anxiety (time frame: Day of surgery versus 7 days post-operative). 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 29 Oct 2026.