Peppermint Aroma and Physiological Parameters

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication
• Interventions: Other: Aromatherapy; Other: Placebo

• Registration Number: NCT05541809
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-14
• Primary Completion: 2022-09-15
• Study First Posted: 2022-09-15
• Study Completion: 2022-09-30
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peppermint group	Aromatherapy	This group will receive peppermint oil aroma
Water group	Placebo	This group will receive water as an aroma oil

Primary Outcome Measures

Name	Time	Method
Respiratory rate	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	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	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.
Heart rate	Change from baseline heart rate at one hour.	The number of heart beats in one minute. It will be reported in beat per minute.

Trial Locations

Locations (1)

Alexandria University, Faculty of nursing; 🇪🇬 Alexandria, Egypt