Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aromatherapy Versus Gum Chewing on Preoperative Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04971668
Recruitment Status : Completed
First Posted : July 21, 2021
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Omar Makram Soliman, 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.

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971668


Locations
Layout table for location information
Egypt
Assiut university hospital
Assiut, Assuit, Egypt, Assuit universi
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: Omar Soliman, MD Omar makram
Publications of Results:
Layout table for additonal information
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    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders