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Peppermint Aroma and Physiological Parameters

Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05541809
Enrollment
106
Registered
2022-09-15
Start date
2022-06-01
Completion date
2022-09-30
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

Brief 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.

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.

Interventions

OTHERAromatherapy

Peppermint aroma inhalation

OTHERPlacebo

Water inhalation

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Patients with * (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.

Exclusion criteria

Patients with * (1) respiratory asthma * (2) chronic obstructive pulmonary disease * (3) acute respiratory distress syndrome, * Sniffin' Sticks-test score of smell less than 17

Design outcomes

Primary

MeasureTime frameDescription
Heart rateChange from baseline heart rate at one hour.The number of heart beats in one minute. It will be reported in beat per minute.
Respiratory rateChange from baseline respiratory rate at one hour.The number of breaths in one minute. It will be reported in breath per minute.
Mean blood pressureChange 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 scoreChange 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026