Aromatherapy Versus Gum Chewing on Preoperative Anxiety

NCT04971668 | Completed DMC

• 1 other identifier: 17300635
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Preoperative anxiety scale assessed by STAI questionnaire

  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 Outcomes (2)

• Postoperative sore throat (POST) score

  Postoperative 24 hour

• Postoperative nausea and vomiting (PONV) score

  Postoperative 24 hour

Study Arms (3)

Aromatherapy

EXPERIMENTAL

Designated blend aromatherapy (ginger \& lavender) and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes.

Other: Aromatherapy

Gum Chewing

EXPERIMENTAL

Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.

Other: Gum Chewing

Placebo

OTHER

Patient will simulate like chewing gum and inhale deeply with inert gauze for 5 minutes.

Other: Controlled

Interventions

Aromatherapy OTHER

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.

Aromatherapy

Gum Chewing OTHER

Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.

Gum Chewing

Controlled OTHER

Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

Location

Related Publications (1)

• Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.

  PMID: 29624026 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Aromatherapy; Chewing Gum; Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Omar Soliman, MD

  Omar makram

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: July 12, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 10, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

EG (1)