AnxietyNCT04971668
Aromatherapy Versus Gum Chewing on Preoperative Anxiety
A study testing Aromatherapy and Gum Chewing in people with Anxiety, run by Assiut University at 1 site in Egypt.
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 \&… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- Aromatherapy and Gum Chewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2021to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Aromatherapy, Gum Chewing, Controlled
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
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 ChewingOther
Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
ControlledOther
Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | Designated blend aromatherapy (ginger \& lavender) and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes. Receives: Other: Aromatherapy |
| Gum Chewing | Experimental | Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes. Receives: Other: Gum Chewing |
| Placebo | Other | Patient will simulate like chewing gum and inhale deeply with inert gauze for 5 minutes. Receives: Other: Controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative 15 minutes
Secondary outcomes (2)
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.
Measured: Postoperative 24 hour
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.
Measured: Postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start12 Jul 2021
- Primary completion2 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
- Investigators
- Omar Soliman, MD, Study director, Omar makram
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971668
- Sponsor's protocol ID
- 17300635
- Status last verified
- Dec 2021
- First submitted
- 12 Jul 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29624026
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04971668
- Acronym / sponsor ID
- 17300635
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: AromatherapyDesignated blend aromatherapy (ginger \& lavender) and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes. |
| Gum Chewing | Experimental | Other: Gum ChewingPatients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes. |
| Placebo | Other | Other: ControlledPatient will simulate like chewing gum and inhale deeply with inert gauze for 5 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyThree 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. | Other | Aromatherapy |
| Gum ChewingPatients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes. | Other | Gum Chewing |
| ControlledPatients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes. | Other | Placebo |
Primary outcome
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
2 secondary outcomes
Postoperative sore throat (POST) score
Time frame: Postoperative 24 hour
Postoperative nausea and vomiting (PONV) score
Time frame: Postoperative 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Results publication: PubMed 29624026Stamenkovic 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Soliman, MD study director
Omar makram
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Gum Chewing in people with Anxiety, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety scale assessed by STAI questionnaire (time frame: Preoperative 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.