The Effect of Aromatherapy on Anxiety in Patients

The Effect of Aromatherapy on Anxiety in Patients Undergoing Genicular Nerve Radiofrequency for Painful Knee Osteoarthritis

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

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Drug: Lavender Oil

Detailed Description

Alot of patients face fear from intervention such as radiofrequency. The group of patients with chronic knee osteoarthritis already and mostly have some sore of psychological upset, radiofrequency itself , even in the presence of good periinterventional local anesthetic infiltration, the patients suffer pain and stress. It is well evidenced that aromatherapy specially with Lavender oil offers some sort of anxiety alleviation, pain alleviation and protection against postoperative nausea and vomiting

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Emad Zarief Kamel Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: Lavender; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of Pain visual analog scale	change of Pain visual analog scale, Scale from 0 ( no pain ) up to 10 (worst experienced pain)	Preintervention, 15 minutes postintervention

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRB00202205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No