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Aromatherapy Versus Gum Chewing on Preoperative Anxiety

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aromatherapy
Gum Chewing
Controlled
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Aromatherapy

Gum Chewing

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 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.

Full Information

First Posted
July 12, 2021
Last Updated
December 27, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04971668
Brief Title
Aromatherapy Versus Gum Chewing on Preoperative Anxiety
Official Title
Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aromatherapy
Arm Type
Experimental
Arm Description
Designated blend aromatherapy (ginger & lavender) and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes.
Arm Title
Gum Chewing
Arm Type
Experimental
Arm Description
Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
Arm Title
Placebo
Arm Type
Other
Arm Description
Patient will simulate like chewing gum and inhale deeply with inert gauze for 5 minutes.
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gum Chewing
Intervention Description
Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
Intervention Type
Other
Intervention Name(s)
Controlled
Intervention Description
Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.
Primary Outcome Measure Information:
Title
Preoperative anxiety scale assessed by STAI questionnaire
Description
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
Time Frame
Preoperative 15 minutes
Secondary Outcome Measure Information:
Title
Postoperative sore throat (POST) score
Description
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.
Time Frame
Postoperative 24 hour
Title
Postoperative nausea and vomiting (PONV) score
Description
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.
Time Frame
Postoperative 24 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Omar makram
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29624026
Citation
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.
Results Reference
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Aromatherapy Versus Gum Chewing on Preoperative Anxiety

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