Aromatherapy Versus Gum Chewing on Preoperative Anxiety

Anxiety Clinical Trial

Official title:

Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971668
• Other study ID #: 17300635
• Status: Completed
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 10, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.
• Gum Chewing
Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
• Controlled
Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative sore throat (POST) score	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
Secondary	Postoperative nausea and vomiting (PONV) score	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