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Effect of Aromatherapy on Preoperative Anxiety Level

NCT05853744 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-18

No results posted yet for this study

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

Interventions

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Mongi Slim Hospital

    lead OTHER

Principal Investigators

  • Mhamed Sami MS Mebazaa, Pr · Mongi Slim local

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2023-10-31
Completion
2023-12-30

Countries

  • Tunisia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853744 on ClinicalTrials.gov