Back to resultsThe Effect of Aromatherapy on Anxiety in Patients
Primary Purpose
Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lavender Oil
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- adult patients with knee osteoarthritis
- scheduled for genicular nerve radiofrequency
Exclusion Criteria:
- Allergy to lavender
- psychological disorders
- upper respiratory tract illness
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lavender
Control
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change of Pain visual analog scale
change of Pain visual analog scale, Scale from 0 ( no pain ) up to 10 (worst experienced pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05500664
Brief Title
The Effect of Aromatherapy on Anxiety in Patients
Official Title
The Effect of Aromatherapy on Anxiety in Patients Undergoing Genicular Nerve Radiofrequency for Painful Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Preoperative anxiety is considered a potential and preventable risk factor for postoperative complications.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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) questionnaire
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavender
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Lavender Oil
Intervention Description
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
Primary Outcome Measure Information:
Title
change of Speilberger State-Trait Anxiety Inventory
Description
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.
Time Frame
preintervention, 15 minutes postintervention
Secondary Outcome Measure Information:
Title
change of Pain visual analog scale
Description
change of Pain visual analog scale, Scale from 0 ( no pain ) up to 10 (worst experienced pain)
Time Frame
Preintervention, 15 minutes postintervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients with knee osteoarthritis
scheduled for genicular nerve radiofrequency
Exclusion Criteria:
Allergy to lavender
psychological disorders
upper respiratory tract illness
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Aromatherapy on Anxiety in Patients
We'll reach out to this number within 24 hrs