search
Back to results

Effect of Aromatherapy on Preoperative Anxiety Level

Primary Purpose

Anxiety, Aromatherapy, Anesthesia, Spinal

Status
Recruiting
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
lavender essential oil inhaled using cotton balls
lavender essential oil inhaled using face mask
Distilled water
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Surgery under spinal anesthesia: continuous or single shot; Conscious patient cooperative able to communicate; No preoperative cognitive disorder; Patient consent; American society of anesthesiologists' (ASA) physical status of I-III Exclusion Criteria: Pregnant or breastfeeding women; Asthma; Chronic obstructive pulmonary disease; Allergic to essentials oils; Anosmia; History of chronic anxiety or depression; Neuropsychiatric disorder; Use of anti-anxiety medications or anti-depressants; Drug addiction; Emergency surgery required immediately or within 6 hours.

Sites / Locations

  • Mongi Slim hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group C

Group M

Group P

Arm Description

patients receiving aromatherapy using cotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask.

- Group M: inhaled three drops of lavender oil through a facemask. These three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer. A cotton ball soaked with water was put 10 cm next to the patient.

Placebo group: inhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient.

Outcomes

Primary Outcome Measures

Anxiety level
Visual Analogue Scale (minimum value 0 means no anxiety and maximum value 10 means the highest anxiety level)

Secondary Outcome Measures

Pre-operative anxiety and information scale
Amsterdam anxiety and information scale
Anti-anxiety medications requirement
the need of midazolam
Patient satisfaction
Iowa Satisfaction with Anesthesia scale

Full Information

First Posted
April 29, 2023
Last Updated
September 22, 2023
Sponsor
Mongi Slim Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05853744
Brief Title
Effect of Aromatherapy on Preoperative Anxiety Level
Official Title
Effect of Aromatherapy on Preoperative Anxiety Level
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia. This was a prospective double blinded randomized controlled trial. After patient's approval, the anxiety level was assessed preoperativetively with Visual Analogue scale-anxiety and APAIS scale. To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil. After randomisation and allocation, the investigators prooceeded with the intervention preoperatively. In the operating room, the acte under spinal anethesia was performed. Then we collect data postoperatively.
Detailed Description
Preoperative anxiety is a common occurrence that has the potential to be harmful, with prevalence rates in the literature ranging from 27% to 80%. Clinical manifestation ranges from malaise to acute stress disorder that meets the criteria of Diagnostic and Statistical Manual of Mental Disorders 5 (DSM5).It is associated with a rise of peri-operative morbidity and mortality. Anti-anxiety medications may be effective but it comes with a number of undesirable adverse effects. Aromatherapy is a non-pharmacological approach that is alluring, affordable, and inexpensive and has minimal side effects, but there aren't enough studies to support its efficacy. The aim of our study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia. This was a prospective double blinded randomized controlled trial The patients were seen the night before the surgery, a pre-anesthetic visit was performed. To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil. Surgery day, one hour before operation, vital signs were taken: Heart rate, respiratory rate, pulse oximetry, systolic arterial pressure and diastolic arterial pressure. Then patients were assessed for anxiety using, Visual Analogue scale-anxiety and APAIS scale. Next, the investigators proceeded with the intervention and patients were assigned into the 3 group of the study. In the operating room, Spinal anesthesia was performed. After surgery the investigators evaluated anxiety level (VAS-A) and post-operative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Aromatherapy, Anesthesia, Spinal, Postoperative Period

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sequentially numbered and sealed opaque envelopes method was used to carry out the randomization and allocation. These were done by a different doctor from the one caring for the patient in the peri-operative period.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Experimental
Arm Description
patients receiving aromatherapy using cotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask.
Arm Title
Group M
Arm Type
Active Comparator
Arm Description
- Group M: inhaled three drops of lavender oil through a facemask. These three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer. A cotton ball soaked with water was put 10 cm next to the patient.
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Placebo group: inhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient.
Intervention Type
Drug
Intervention Name(s)
lavender essential oil inhaled using cotton balls
Other Intervention Name(s)
Aromatherapy
Intervention Description
cotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask.
Intervention Type
Drug
Intervention Name(s)
lavender essential oil inhaled using face mask
Other Intervention Name(s)
Aromatherapy
Intervention Description
These three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer throughout a face mask. A cotton ball soaked with water was put 10 cm next to the patient.
Intervention Type
Drug
Intervention Name(s)
Distilled water
Other Intervention Name(s)
Placebo
Intervention Description
inhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient.
Primary Outcome Measure Information:
Title
Anxiety level
Description
Visual Analogue Scale (minimum value 0 means no anxiety and maximum value 10 means the highest anxiety level)
Time Frame
before and 30 minutes after the intervention 2 hours befor surgery
Secondary Outcome Measure Information:
Title
Pre-operative anxiety and information scale
Description
Amsterdam anxiety and information scale
Time Frame
before and 30 minutes after the intervention 2 hours befor surgery
Title
Anti-anxiety medications requirement
Description
the need of midazolam
Time Frame
Fifteen minutes before spinal anesthesia or during the act
Title
Patient satisfaction
Description
Iowa Satisfaction with Anesthesia scale
Time Frame
2 hours after the end of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Surgery under spinal anesthesia: continuous or single shot; Conscious patient cooperative able to communicate; No preoperative cognitive disorder; Patient consent; American society of anesthesiologists' (ASA) physical status of I-III Exclusion Criteria: Pregnant or breastfeeding women; Asthma; Chronic obstructive pulmonary disease; Allergic to essentials oils; Anosmia; History of chronic anxiety or depression; Neuropsychiatric disorder; Use of anti-anxiety medications or anti-depressants; Drug addiction; Emergency surgery required immediately or within 6 hours.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mhamed Sami MS Mebazaa, Pr
Phone
98357425
Ext
00216
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Faten F Haddad, Dr
Phone
26209158
Ext
00216
Email
faten.haddad@hotmail.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami MS Mebazaa, Pr
Organizational Affiliation
Mongi Slim local
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongi Slim hospital
City
Tunis
ZIP/Postal Code
2085
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mhamed sami Mebazaa, Pr
Phone
22252589
Ext
00216
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name & Degree
Faten F Haddad, Dr
Phone
26209158
Ext
00216
Email
faten.haddad@hotmail.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Aromatherapy on Preoperative Anxiety Level

We'll reach out to this number within 24 hrs