Effect of Aromatherapy on Preoperative Anxiety Level

Anxiety Clinical Trial

Official title:

Effect of Aromatherapy on Preoperative Anxiety Level

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853744
• Other study ID #: aromatherapy
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: Mongi Slim Hospital
• Contact: Mhamed Sami MS Mebazaa, Pr
• Phone: 98357425
• Email: msmebazaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Anxiety
• Anxiety Disorders
• Aromatherapy
• Postoperative Period

Intervention

Drug:
• lavender essential oil inhaled using cotton balls
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 mask
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 water
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.

Locations

Country	Name	City	State
Tunisia	Mongi Slim hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

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