The Effect of Aromatherapy on Anxiety in Patients

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05500664
• Other study ID #: IRB00202205
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• adult patients with knee osteoarthritis

• scheduled for genicular nerve radiofrequency

Exclusion Criteria:

• Allergy to lavender

• psychological disorders

• upper respiratory tract illness

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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