Acute PainNCT06294769
Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial
A study testing essencial oil of lavandula angustifolia and grape seed vegetable oil in people with Acute Pain and Perioperative/Postoperative Complications, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Pain, Perioperative/Postoperative Complications, CAM
- What is being tested?
- essencial oil of lavandula angustifolia and grape seed vegetable oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Mar 2024to 31 Jul 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type
Who cannot join
- individuals diagnosed with dementia, cognitive impairment or chronic pain;
- individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention;
- procedure for reoperation for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aromatherapy on Postoperative Pain in Adult Patients in Post-anesthesics Recovering Room: Randomized Clinical Trial
Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.
- Being tested
- essencial oil of lavandula angustifolia, grape seed vegetable oil
- Keywords
- Acute Pain, Perioperative Nursing, Aromatherapy
- Medical subject headings
- Acute Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essencial oil of lavandula angustifoliaOther
The intervention will consist of the application of aromatherapy with 2% lavender essential oil cutaneously and inhalation via by a nurse, associated with usual care, in the immediate postoperative period
grape seed vegetable oilOther
The placebo group will only receive the application of grape seed vegetable oil associated with usual care in the immediate postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 2% lavender essential oil. | Experimental | Group will receive application of aromatherapy with 2% lavender essential oil dermal and inhalation via by a nurse, associated with usual care, in the immediate postoperative period. Receives: Other: essencial oil of lavandula angustifolia |
| Group 2: grape seed vegetable oil. | Placebo comparator | Placebo group will only receive the application of grape seed vegetable oil associated with usual care in the post anesthetic recovery room. Receives: Other: grape seed vegetable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute pain
A numerical verbal scale (1 to 10) for assessing pain upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room.
Measured: 2 hours
Secondary outcomes (5)
Blood pressure (both systolic and diastolic)
Non-invasive blood pressure measurement (in mmHg) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room
Measured: 2 hours
Heart rate
Heart rate measurement with multi parameter monitor(in bpm) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room
Measured: 2 hours
Respiratory frequency
Respiratory frequency assessment (breathing rate by counting the number of breaths per minute) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room
Measured: 2 hours
Oxygen saturation
Oxygen saturation (SpO2) measurement (in percent (%), with a pulse oximeter non-invasive device) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room
Measured: 2 hours
Temperature
Temperature assessment (in Celsius scale ) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start18 Mar 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Fernanda de Oliveira Faria, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294769
- Sponsor's protocol ID
- 022024 Maria Fernanda
- Status last verified
- Dec 2024
- First submitted
- 14 Feb 2024
- Last updated
- 16 Dec 2024
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatherapy on Postoperative Pain in Adult Patients in Post-anesthesics Recovering Room: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06294769
- Acronym / sponsor ID
- 022024 Maria Fernanda
- Keywords
- Acute Pain, Perioperative Nursing, Aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Mar 2024 (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.
Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 2% lavender essential oil. | Experimental | Other: essencial oil of lavandula angustifoliaGroup will receive application of aromatherapy with 2% lavender essential oil dermal and inhalation via by a nurse, associated with usual care, in the immediate postoperative period. |
| Group 2: grape seed vegetable oil. | Placebo comparator | Other: grape seed vegetable oilPlacebo group will only receive the application of grape seed vegetable oil associated with usual care in the post anesthetic recovery room. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type
Key exclusion criteria (3 listed)
- individuals diagnosed with dementia, cognitive impairment or chronic pain;
- individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention;
- procedure for reoperation for any reason
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 |
|---|---|---|
| essencial oil of lavandula angustifoliaThe intervention will consist of the application of aromatherapy with 2% lavender essential oil cutaneously and inhalation via by a nurse, associated with usual care, in the immediate postoperative period | Other | Group 1: 2% lavender essential oil. |
| grape seed vegetable oilThe placebo group will only receive the application of grape seed vegetable oil associated with usual care in the immediate postoperative period. | Other | Group 2: grape seed vegetable oil. |
Primary outcome
Acute pain
Time frame: 2 hours
A numerical verbal scale (1 to 10) for assessing pain upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room.
5 secondary outcomes
Blood pressure (both systolic and diastolic)
Time frame: 2 hours
Heart rate
Time frame: 2 hours
Respiratory frequency
Time frame: 2 hours
Oxygen saturation
Time frame: 2 hours
Temperature
Time frame: 2 hours
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 16 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing essencial oil of lavandula angustifolia and grape seed vegetable oil in people with Acute Pain and Perioperative/Postoperative Complications, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 3 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 16 Dec 2024. 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 Brazil. 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?
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?
Acute pain (time frame: 2 hours). 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 16 Dec 2024.