Effect of Aromatherapy on Preoperative Anxiety Level

NCT05853744 | Completed Phase 4

• 1 other identifier: aromatherapy
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Aromatherapy; Anesthesia, Spinal; Postoperative Period

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pre-operative anxiety and information scale

  before and 30 minutes after the intervention 2 hours befor surgery

• Anti-anxiety medications requirement

  Fifteen minutes before spinal anesthesia or during the act

• Patient satisfaction

  2 hours after the end of the surgery

Study Arms (3)

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.

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.

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.

Drug: Distilled water

Interventions

lavender essential oil inhaled using cotton balls DRUG

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.

Also known as: Aromatherapy

Group C

lavender essential oil inhaled using face mask DRUG

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.

Also known as: Aromatherapy

Group M

Distilled water DRUG

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.

Also known as: Placebo

Group P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim hospital

Tunis, 2085, Tunisia

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mhamed Sami MS Mebazaa, Pr

  Mongi Slim local

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sequentially numbered and sealed opaque envelopes method was used to carry out the randomization and allocation. These were done by a different doctor from the one caring for the patient in the peri-operative period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 11, 2023
• Study Start: August 2, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 30, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)