AnxietyPhase 4NCT05853744
Effect of Aromatherapy on Preoperative Anxiety Level
A Phase 4 study testing lavender essential oil inhaled using cotton balls, lavender essential oil inhaled using face mask and Distilled water in people with Anxiety and Aromatherapy, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
The aim of the study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia. This was a prospective double blinded randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Aromatherapy, Anesthesia, Spinal
- What is being tested?
- lavender essential oil inhaled using cotton balls, lavender essential oil inhaled using face mask and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Aug 2023to 30 Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery under spinal anesthesia: continuous or single shot;
- Conscious patient cooperative able to communicate;
- No preoperative cognitive disorder;
- Patient consent;
- American society of anesthesiologists' (ASA) physical status of I-III
Who cannot join
- Pregnant or breastfeeding women;
- Asthma;
- Chronic obstructive pulmonary disease;
- Allergic to essentials oils;
- Anosmia;
- History of chronic anxiety or depression;
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- Neuropsychiatric disorder;
- Use of anti-anxiety medications or anti-depressants;
- Drug addiction;
- Emergency surgery required immediately or within 6 hours.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia.
This was a prospective double blinded randomized controlled trial. After patient's approval, the anxiety level was assessed preoperativetively with Visual Analogue scale-anxiety and APAIS scale. To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil. After randomisation and allocation, the investigators prooceeded with the intervention preoperatively. In the operating room, the acte under spinal anethesia was performed. Then we collect data postoperatively.
Read the detailed description
Preoperative anxiety is a common occurrence that has the potential to be harmful, with prevalence rates in the literature ranging from 27% to 80%. Clinical manifestation ranges from malaise to acute stress disorder that meets the criteria of Diagnostic and Statistical Manual of Mental Disorders 5 (DSM5).It is associated with a rise of peri-operative morbidity and mortality. Anti-anxiety medications may be effective but it comes with a number of undesirable adverse effects. Aromatherapy is a non-pharmacological approach that is alluring, affordable, and inexpensive and has minimal side effects, but there aren't enough studies to support its efficacy.
The aim of our study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia.
This was a prospective double blinded randomized controlled trial The patients were seen the night before the surgery, a pre-anesthetic visit was performed.
To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil.
Surgery day, one hour before operation, vital signs were taken: Heart rate, respiratory rate, pulse oximetry, systolic arterial pressure and diastolic arterial pressure.
Then patients were assessed for anxiety using, Visual Analogue scale-anxiety and APAIS scale.
Next, the investigators proceeded with the intervention and patients were assigned into the 3 group of the study. In the operating room, Spinal anesthesia was performed. After surgery the investigators evaluated anxiety level (VAS-A) and post-operative pain.
- Conditions
- Anxiety, Aromatherapy, Anesthesia, Spinal, Postoperative Period
- Being tested
- lavender essential oil inhaled using cotton balls, lavender essential oil inhaled using face mask, Distilled water
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lavender essential oil inhaled using cotton ballsDrug
Also called Aromatherapy
cotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask.
lavender essential oil inhaled using face maskDrug
Also called Aromatherapy
These three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer throughout a face mask. A cotton ball soaked with water was put 10 cm next to the patient.
Distilled waterDrug
Also called Placebo
inhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Experimental | patients receiving aromatherapy using cotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask. Receives: Drug: lavender essential oil inhaled using cotton balls |
| Group M | Active comparator | - Group M: inhaled three drops of lavender oil through a facemask. These three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer. A cotton ball soaked with water was put 10 cm next to the patient. Receives: Drug: lavender essential oil inhaled using face mask |
| Group P | Placebo comparator | Placebo group: inhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient. Receives: Drug: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Visual Analogue Scale (minimum value 0 means no anxiety and maximum value 10 means the highest anxiety level)
Measured: before and 30 minutes after the intervention 2 hours befor surgery
Secondary outcomes (3)
Pre-operative anxiety and information scale
Amsterdam anxiety and information scale contains six questions, grouped into two components: anxiety subscale (questions 1, 2, 4, and 5) and the need for information subscale (questions 3 and 6).Questions are scored based on Likert's method from 1 ("not at all") to 5 ("extremely"). For the subscale related to the anxiety, the total score ranges from 4 to 20, while for the part of the scale related to the need for information the range is from 2 to 10. A higher score speaks in favor of a higher level of anxiety and a greater need for information. According to the part of the scale related to preoperative anxiety, a patient with a score ≥11 experiences anxiety; according to the part of the scale related to the need for information related to anesthesia and surgery, patients are classified into those who have little or no need for information (score 2-4), those who have an average (score 5-7) and those who have high information requirements (score 8-10)
Measured: before and 30 minutes after the intervention 2 hours befor surgery
Anti-anxiety medications requirement
the need of midazolam
Measured: Fifteen minutes before spinal anesthesia or during the act
Patient satisfaction
Iowa Satisfaction with Anesthesia scale consists of eleven items, which either correspond to positive or negative feelings as follows:
- Three items aim to assess the patient's pain.
- Six items investigate the patient's other post-operative sensations.
- Two items require the patient to record his or her anesthetic experience.
The offered response for each item is a Likert-like six-point scale, with each response given as a satisfaction score ranging from - 3 to 3:
- 3 = disagree very much; + 3 = agree very much. Response to" negative" questions are reversed so that, a totally satisfied patient would score +3 on all questions. The total satisfaction score is the unweighted average of these 11 scores, so its expected range is also -3 to +3.
Measured: 2 hours after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start2 Aug 2023
- Primary completion31 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami MS Mebazaa, Pr, Principal investigator, Mongi Slim local
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853744
- Sponsor's protocol ID
- aromatherapy
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2023
- Last updated
- 18 Jul 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatherapy on Preoperative Anxiety Level
- ClinicalTrials.gov ID
- NCT05853744
- Acronym / sponsor ID
- aromatherapy
- Conditions
- Anxiety, Aromatherapy, Anesthesia, Spinal, Postoperative Period
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 11 May 2023 (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.
The aim of the study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia.
This was a prospective double blinded randomized controlled trial. After patient's approval, the anxiety level was assessed preoperativetively with Visual Analogue scale-anxiety and APAIS scale. To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil. After randomisation and allocation, the investigators prooceeded with the intervention preoperatively. In the operating room, the acte under spinal anethesia was performed. Then we collect data postoperatively.
Detailed description
Preoperative anxiety is a common occurrence that has the potential to be harmful, with prevalence rates in the literature ranging from 27% to 80%. Clinical manifestation ranges from malaise to acute stress disorder that meets the criteria of Diagnostic and Statistical Manual of Mental Disorders 5 (DSM5).It is associated with a rise of peri-operative morbidity and mortality. Anti-anxiety medications may be effective but it comes with a number of undesirable adverse effects. Aromatherapy is a non-pharmacological approach that is alluring, affordable, and inexpensive and has minimal side effects, but there aren't enough studies to support its efficacy.
The aim of our study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia.
This was a prospective double blinded randomized controlled trial The patients were seen the night before the surgery, a pre-anesthetic visit was performed.
To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil.
Surgery day, one hour before operation, vital signs were taken: Heart rate, respiratory rate, pulse oximetry, systolic arterial pressure and diastolic arterial pressure.
Then patients were assessed for anxiety using, Visual Analogue scale-anxiety and APAIS scale.
Next, the investigators proceeded with the intervention and patients were assigned into the 3 group of the study. In the operating room, Spinal anesthesia was performed. After surgery the investigators evaluated anxiety level (VAS-A) and post-operative pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Experimental | Drug: lavender essential oil inhaled using cotton ballspatients receiving aromatherapy using cotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask. |
| Group M | Active comparator | Drug: lavender essential oil inhaled using face mask- Group M: inhaled three drops of lavender oil through a facemask. These three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer. A cotton ball soaked with water was put 10 cm next to the patient. |
| Group P | Placebo comparator | Drug: Distilled waterPlacebo group: inhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Surgery under spinal anesthesia: continuous or single shot;
- Conscious patient cooperative able to communicate;
- No preoperative cognitive disorder;
- Patient consent;
- American society of anesthesiologists' (ASA) physical status of I-III
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women;
- Asthma;
- Chronic obstructive pulmonary disease;
- Allergic to essentials oils;
- Anosmia;
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 essential oil inhaled using cotton ballsAlso: Aromatherapycotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask. | Drug | Group C |
| lavender essential oil inhaled using face maskAlso: AromatherapyThese three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer throughout a face mask. A cotton ball soaked with water was put 10 cm next to the patient. | Drug | Group M |
| Distilled waterAlso: Placeboinhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient. | Drug | Group P |
Primary outcome
Anxiety level
Time frame: before and 30 minutes after the intervention 2 hours befor surgery
Visual Analogue Scale (minimum value 0 means no anxiety and maximum value 10 means the highest anxiety level)
3 secondary outcomes
Pre-operative anxiety and information scale
Time frame: before and 30 minutes after the intervention 2 hours befor surgery
Anti-anxiety medications requirement
Time frame: Fifteen minutes before spinal anesthesia or during the act
Patient satisfaction
Time frame: 2 hours after the end of the surgery
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 18 Jul 2024.
- 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.
Mhamed Sami MS Mebazaa, Pr principal investigator
Mongi Slim local
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lavender essential oil inhaled using cotton balls, lavender essential oil inhaled using face mask and Distilled water in people with Anxiety and Aromatherapy, run by Mongi Slim Hospital at 1 site in Tunisia.
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 10 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 18 Jul 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 Tunisia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anxiety level (time frame: before and 30 minutes after the intervention 2 hours befor surgery). 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 Jul 2024.