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Aromatherapy Versus Gum Chewing on Preoperative Anxiety

NCT ID: NCT04971668

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2021-12-10

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Aromatherapy

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

Group Type EXPERIMENTAL

Aromatherapy

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Gum Chewing

Intervention Type OTHER

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.

Group Type OTHER

Controlled

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Gum Chewing

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

Intervention Type OTHER

Controlled

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Makram Soliman

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Soliman, MD

Role: STUDY_DIRECTOR

Omar makram

Locations

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Assiut university hospital

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 29624026 (View on PubMed)

Other Identifiers

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17300635

Identifier Type: -

Identifier Source: org_study_id