Peppermint Aroma and Physiological Parameters

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Other: Aromatherapy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peppermint group<br>This group will receive peppermint oil aroma | Other: Aromatherapy<br>* Peppermint aroma inhalation<br>|
| Placebo Comparator: Water group<br>This group will receive water as an aroma oil | Other: Placebo<br>* Water inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | The number of heart beats in one minute. It will be reported in beat per minute. | 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. | 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). | 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. | Change from baseline pain score at one hour. |