Clinical trial NCT05853744: Effect of Aromatherapy on Preoperative Anxiety Level
Official title: Effect of Aromatherapy on Preoperative Anxiety Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety
Aromatherapy
Anesthesia, Spinal
Postoperative Period
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety level
timeFrame: before and 30 minutes after the intervention 2 hours befor surgery
Secondary outcomes:
measure: Pre-operative anxiety and information scale
timeFrame: before and 30 minutes after the intervention 2 hours befor surgery
measure: Anti-anxiety medications requirement
timeFrame: Fifteen minutes before spinal anesthesia or during the act
measure: Patient satisfaction
timeFrame: 2 hours after the end of the surgery
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim hospital
Study officials:
affiliation: Mongi Slim local
name: Mhamed Sami MS Mebazaa, Pr
role: PRINCIPAL_INVESTIGATOR
References: