Aromatherapy Versus Gum Chewing on Preoperative Anxiety

• ClinicalTrials.gov Identifier: NCT04971668
• Recruitment Status: Completed
• First Posted: July 21, 2021
• Last Update Posted: December 28, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Omar Makram Soliman, Assiut University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxiety	Other: Aromatherapy; Other: Gum Chewing; Other: Controlled	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial
• Actual Study Start Date: July 12, 2021
• Actual Primary Completion Date: December 2, 2021
• Actual Study Completion Date: December 10, 2021

Arms and Interventions

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.	Other: Aromatherapy; 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.	Other: Gum Chewing; Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
Placebo; Patient will simulate like chewing gum and inhale deeply with inert gauze for 5 minutes.	Other: Controlled; Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Assiut university hospital

Assiut, Assuit, Egypt, Assuit universi

Sponsors and Collaborators

Assiut University

Investigators

• Study Director: Omar Soliman, MD; Omar makram

More Information

Publications of Results:

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. Review.

• Responsible Party: Omar Makram Soliman, Lecturer of anesthesia and ICU, Assiut University
• ClinicalTrials.gov Identifier: NCT04971668
• Other Study ID Numbers: 17300635
• First Posted: July 21, 2021
• Last Update Posted: December 28, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders