The Effect of Aromatherapy on Anxiety in Patients

NCT05500664 | Completed DMC

• 1 other identifier: IRB00202205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative anxiety is considered a potential and preventable risk factor for postoperative complications.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (1)

• change of Speilberger State-Trait Anxiety Inventory

  change of Speilberger State-Trait Anxiety Inventory , There are 20 questions (I feel calm, secure, tense, strained, at ease, upset, am presently worrying over possible misfortunes, satisfied, frightened, uncomfortable, self-confident, nervous, jittery, indecisive, relaxed, content, worried, confused, steady and pleasant) where people rate their anxiety from one (not at all) to four (very much so), and scores range from 20 to 80. low anxiety is 20 to 37, moderate anxiety is 38 to 44, and high anxiety is 45 to 80.

  preintervention, 15 minutes postintervention

Secondary Outcomes (1)

• change of Pain visual analog scale

  Preintervention, 15 minutes postintervention

Study Arms (2)

Lavender

ACTIVE COMPARATOR

three drops of the designated lavender will be placed on a 2-inch by 2-inch impermeable, backed gauze pad and patient was asked to inhale deeply for 5 minutes

Drug: Lavender Oil

Control

NO INTERVENTION

Interventions

Lavender Oil DRUG

three drops of the designated lavender will be placed on a 2-inch by 2-inch impermeable, backed gauze pad and patient was asked to inhale deeply for 5 minutes

Lavender

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients with knee osteoarthritis
• scheduled for genicular nerve radiofrequency

You may not qualify if:

• Allergy to lavender
• psychological disorders
• upper respiratory tract illness

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We hypothesized that the use of lavender aromatherapy before surgery would reduce preintervntion of radiofrequency anxiety as assessed by the Speilberger State-Trait Anxiety Inventory (STAI) questionnaire

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: August 15, 2022
• Study Start: January 20, 2022
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

EG (1)