Mechanical Ventilation ComplicationNCT05541809
Peppermint Aroma and Physiological Parameters
A study testing Aromatherapy in people with Mechanical Ventilation Complication, run by Alexandria University at 1 site in Egypt.
Trial summary
Three drops of peppermint oil will be dropped on a cotton ball that will be fixed in the patient's collar. In the placebo group, peppermint oil will be replaced with water. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Sep 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) endotracheal tube (ETT)
- (2) mechanical ventilation with spontaneous breathing modes which are CPAP, PIPAP and PSV
- (3) FOUR score equal to or more than 13,
- (4) RASS score from -1 to +4.
Who cannot join
- (1) respiratory asthma
- (2) chronic obstructive pulmonary disease
- (3) acute respiratory distress syndrome,
- Sniffin' Sticks-test score of smell less than 17
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients
Three drops of peppermint oil will be dropped on a cotton ball that will be fixed in the patient's collar. In the placebo group, peppermint oil will be replaced with water.
Read the detailed description
Mechanical ventilathetion increases the anxiety of critically ill patients. The physiological parameters of those patients are affected by stress. Peppermint inhalation reduces stress and improves physiological parameters in many studies, but none of these studies used peppermint inhalation on mechanically ventilated patients.
Patients who are conscious on mechanical ventilation via endotracheal via tube will be randomly assigned to two groups. Patients will be kept intubated and mechanically ventilated. Nothing will be changed in patients' mechanical ventilation data. The intervention group will receive peppermint inhalation intervention, and the placebo group received water inhalation intervention. Patients in both groups will be assessed for their smell ability by Sniffin Sticks-test before starting the interventions.
Three drops of undiluted peppermint oil will be dropped on a cotton ball. Then it will be placed about 20 cm from the patient's nose. It will be fixed on the patient's collar. In the placebo group, the cotton ball will be soaked in water. Then, patients will be monitored for one hour.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Aromatherapy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Peppermint aroma inhalation
PlaceboOther
Water inhalation
| Study group | Role | What they receive |
|---|---|---|
| Peppermint group | Experimental | This group will receive peppermint oil aroma Receives: Other: Aromatherapy |
| Water group | Placebo comparator | This group will receive water as an aroma oil Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
The number of heart beats in one minute. It will be reported in beat per minute.
Measured: Change from baseline heart rate at one hour.
Respiratory rate
The number of breaths in one minute. It will be reported in breath per minute.
Measured: Change from baseline respiratory rate at one hour.
Mean blood pressure
Mean blood pressure equal diastolic blood pressure + 1/3 [systolic blood pressure - diastolic blood pressure]. It will be reported in millimeters of mercury (mmHg).
Measured: Change from baseline mean blood pressure at one hour.
Pain score
It will be measured using non verbal pain assessment scale. It consists of five categories; face, movement, guarding, physiology, and respiratory items. It will be reported in score. The maximum score of the scale is 10 which means extremely sever pain, and the minimum score is zero which means no pain.
Measured: Change from baseline pain score at one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jun 2022
- Primary completion15 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541809
- Sponsor's protocol ID
- 1532020
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of the patient data was planned
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT05541809
- Acronym / sponsor ID
- 1532020
- Conditions
- Mechanical Ventilation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Sep 2022 (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.
Three drops of peppermint oil will be dropped on a cotton ball that will be fixed in the patient's collar. In the placebo group, peppermint oil will be replaced with water.
Detailed description
Mechanical ventilathetion increases the anxiety of critically ill patients. The physiological parameters of those patients are affected by stress. Peppermint inhalation reduces stress and improves physiological parameters in many studies, but none of these studies used peppermint inhalation on mechanically ventilated patients.
Patients who are conscious on mechanical ventilation via endotracheal via tube will be randomly assigned to two groups. Patients will be kept intubated and mechanically ventilated. Nothing will be changed in patients' mechanical ventilation data. The intervention group will receive peppermint inhalation intervention, and the placebo group received water inhalation intervention. Patients in both groups will be assessed for their smell ability by Sniffin Sticks-test before starting the interventions.
Three drops of undiluted peppermint oil will be dropped on a cotton ball. Then it will be placed about 20 cm from the patient's nose. It will be fixed on the patient's collar. In the placebo group, the cotton ball will be soaked in water. Then, patients will be monitored for one hour.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peppermint group | Experimental | Other: AromatherapyThis group will receive peppermint oil aroma |
| Water group | Placebo comparator | Other: PlaceboThis group will receive water as an aroma oil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- (1) endotracheal tube (ETT)
- (2) mechanical ventilation with spontaneous breathing modes which are CPAP, PIPAP and PSV
- (3) FOUR score equal to or more than 13,
- (4) RASS score from -1 to +4.
Key exclusion criteria (4 listed)
- (1) respiratory asthma
- (2) chronic obstructive pulmonary disease
- (3) acute respiratory distress syndrome,
- Sniffin' Sticks-test score of smell less than 17
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 |
|---|---|---|
| AromatherapyPeppermint aroma inhalation | Other | Peppermint group |
| PlaceboWater inhalation | Other | Water group |
Primary outcome
Heart rate
Time frame: Change from baseline heart rate at one hour.
The number of heart beats in one minute. It will be reported in beat per minute.
Respiratory rate
Time frame: Change from baseline respiratory rate at one hour.
The number of breaths in one minute. It will be reported in breath per minute.
Mean blood pressure
Time frame: Change from baseline mean blood pressure at one hour.
Mean blood pressure equal diastolic blood pressure + 1/3 [systolic blood pressure - diastolic blood pressure]. It will be reported in millimeters of mercury (mmHg).
Pain score
Time frame: Change from baseline pain score at one hour.
It will be measured using non verbal pain assessment scale. It consists of five categories; face, movement, guarding, physiology, and respiratory items. It will be reported in score. The maximum score of the scale is 10 which means extremely sever pain, and the minimum score is zero which means no pain.
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 24 Oct 2023.
- Individual participant dataSharing planned: No. No sharing of the patient data was planned
Related trials for Mechanical Ventilation Complication
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Not yet recruitingObservational study
Enteral Feeding in Mechanically Ventilated Children
Critical Illness, Mechanical Ventilation Complication
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Mechanical Ventilation Complication, run by Alexandria 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 4 inclusion and 4 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 24 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Heart rate (time frame: Change from baseline heart rate at one hour.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2023; AzTrials last refreshed its copy on 2 Nov 2026.