- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04971668
Aromatherapy Versus Gum Chewing on Preoperative Anxiety
December 27, 2021 updated by: Omar Makram Soliman, Assiut University
Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial
Investigators hypothesized that the use of blend aromatherapy and gum chewing before surgery would reduce preoperative anxiety as assessed by the Speilberger State-Trait Anxiety Inventory (STAI) questionnaire and provide non pharmacological methods to decrease postoperative sore throat, postoperative nausea & vomiting and postoperative pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A written informed consent will be taken from the patients.patients
will be assigned randomly to three groups (30 subjects each) either with preoperative aromatherapy (Group A) or gum chewing (Group G) or control group (Group C) to assess the preoperative anxiety and postoperative sore throat, nausea & vomiting and pain control between the three studied groups.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Assuit
-
Assiut, Assuit, Egypt, Assuit universi
- Assiut University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Educated adult females
- American Society of Anesthesiologists (ASA) physical status I-II
- Listed for elective gynecological laparoscopy surgery under general anesthesia and endotracheal tube (ETT)
Exclusion Criteria:
- Impaired pharyngeal or esophageal function
- Phenylketonuria (contraindication to the sweetener aspartame in chewing gum)
- A fall upper or lower denture (not feasible to chew gum)
- A history of preoperative sore throat, upper respiratory tract illness
- Using steroid or analgesia within the last 48 hour
- Chronic smokers
- Receiving warfarin, heparin, full dose 325 mg aspirin, or clopidogrel
- A history or diagnosis of bleeding diatheses
- Any known allergies to ginger or lavender
- Having head or neck surgery
- History of difficult intubation
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Aromatherapy
Designated blend aromatherapy (ginger & lavender) and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes.
|
Three drops of the designated blend aromatherapy (ginger & lavender) will be placed on a 2-inch by 2-inch impermeable, backed gauze pad and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes.
|
EXPERIMENTAL: Gum Chewing
Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
|
Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
|
OTHER: Placebo
Patient will simulate like chewing gum and inhale deeply with inert gauze for 5 minutes.
|
Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preoperative anxiety scale assessed by STAI questionnaire
Time Frame: Preoperative 15 minutes
|
The STAI takes less than 5 minutes to complete and can be scored in less than 2 minutes.
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.
For example, low anxiety is 20 to 37, moderate anxiety is 38 to 44, and high anxiety is 45 to 80. Assessment will be done at two times; first time (before study intervention)15 minutes preoperatively in the holding area as a baseline with recoding systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate.
Second time; (after study intervention) in the operating room before induction of anesthesia
|
Preoperative 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative sore throat (POST) score
Time Frame: Postoperative 24 hour
|
On arrival in the post anesthesia care unit, the patient is immediately evaluated for the presence of postoperative sore throat (POST); time 0 hour using a standardized scale.
The severity of POST is graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only with questioning), 2 being moderate sore throat (complains on their own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain).
Evaluations will be recorded at 0, 1, 2, 4, 6, 12 and 24 hours after surgery.
Patients with score ≥2; will be given dexamethasone 4 mg and parecoxib 40 mg.
|
Postoperative 24 hour
|
Postoperative nausea and vomiting (PONV) score
Time Frame: Postoperative 24 hour
|
The post anesthesia care unit (PACU) nurses will assess and document postoperative nausea and vomiting (PONV) using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting).
The score will be obtained at 0, 1, 2, 4, 6, 12 and 24 hours after PACU arrival.
In the PACU, ondansetron 4 mg IV will be given for score ≥2.
|
Postoperative 24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Omar Soliman, MD, Omar makram
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 12, 2021
Primary Completion (ACTUAL)
December 2, 2021
Study Completion (ACTUAL)
December 10, 2021
Study Registration Dates
First Submitted
July 12, 2021
First Submitted That Met QC Criteria
July 12, 2021
First Posted (ACTUAL)
July 21, 2021
Study Record Updates
Last Update Posted (ACTUAL)
December 28, 2021
Last Update Submitted That Met QC Criteria
December 27, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17300635
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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