Effect of Aromatherapy on Preoperative Anxiety Level

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Aromatherapy on Preoperative Anxiety Level

Conditions
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Anxiety, Aromatherapy, Anesthesia, Spinal, Postoperative Period

Intervention / Treatment
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* Drug: lavender essential oil inhaled using cotton balls
* Drug: lavender essential oil inhaled using face mask
* Drug: Distilled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant or breastfeeding women; Asthma; Chronic obstructive pulmonary disease; Allergic to essentials oils; Anosmia; History of chronic anxiety or depression; Neuropsychiatric disorder; Use of anti-anxiety medications or anti-depressants; Drug addiction; Emergency surgery required immediately or within 6 hours.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group C<br>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. | Drug: lavender essential oil inhaled using cotton balls<br>* 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.<br>* Other names: Aromatherapy;|
| Active Comparator: Group M<br>- 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. | Drug: lavender essential oil inhaled using face mask<br>* 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.<br>* Other names: Aromatherapy;|
| Placebo Comparator: Group P<br>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. | Drug: Distilled water<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | Visual Analogue Scale (minimum value 0 means no anxiety and maximum value 10 means the highest anxiety level) | before and 30 minutes after the intervention 2 hours befor surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative anxiety and information scale | Amsterdam anxiety and information scale | before and 30 minutes after the intervention 2 hours befor surgery | 
| Anti-anxiety medications requirement | the need of midazolam | Fifteen minutes before spinal anesthesia or during the act | 
| Patient satisfaction | Iowa Satisfaction with Anesthesia scale | 2 hours after the end of the surgery |