The Effect of Aromatherapy on Anxiety in Patients

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT05500664

Collaborator

(none)

Enrollment

Location

Arms

5.3

Actual Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety Pain	Drug: Lavender Oil	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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) questionnaireWe 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

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 20, 2022

Actual Primary Completion Date :

May 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Control

Arm

Intervention/Treatment

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

change of Speilberger State-Trait Anxiety Inventory [preintervention, 15 minutes postintervention]
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.

Secondary Outcome Measures

change of Pain visual analog scale [Preintervention, 15 minutes postintervention]
change of Pain visual analog scale, Scale from 0 ( no pain ) up to 10 (worst experienced pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adult patients with knee osteoarthritis
scheduled for genicular nerve radiofrequency

Exclusion Criteria:

Allergy to lavender
psychological disorders
upper respiratory tract illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emad Zarief Kamel Said	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emad Zarief , MD, Professor, Assiut University

ClinicalTrials.gov Identifier:

NCT05500664

Other Study ID Numbers:

IRB00202205

First Posted:

Aug 15, 2022

Last Update Posted:

Aug 15, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Aug 15, 2022