Peppermint Aroma and Physiological Parameters

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Other: Aromatherapy; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21523
    • Alexandria University, Faculty of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peppermint group; This group will receive peppermint oil aroma	Other: Aromatherapy; Peppermint aroma inhalation
Placebo Comparator: Water group; This group will receive water as an aroma oil	Other: Placebo; Water inhalation

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1532020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing of the patient data was planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No