Aromatherapy Versus Gum Chewing on Preoperative Anxiety

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Aromatherapy; Other: Gum Chewing; Other: Controlled

• Registration Number: NCT04971668
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-21
• Status Verified: 2021-12
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aromatherapy	Aromatherapy	Designated blend aromatherapy (ginger \& lavender) and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes.
Gum Chewing	Gum Chewing	Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
Placebo	Controlled	Patient will simulate like chewing gum and inhale deeply with inert gauze for 5 minutes.

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety scale assessed by STAI questionnaire	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

Name	Time	Method
Postoperative nausea and vomiting (PONV) score	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 sore throat (POST) score	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.

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Assuit, Egypt