Peppermint Aroma and Physiological Parameters

NCT ID: NCT05541809

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-09-30

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.

Conditions

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Peppermint group

This group will receive peppermint oil aroma

Group Type EXPERIMENTAL

Aromatherapy

Intervention Type OTHER

Peppermint aroma inhalation

Water group

This group will receive water as an aroma oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Water inhalation

Interventions

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Aromatherapy

Peppermint aroma inhalation

Intervention Type OTHER

Placebo

Water inhalation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* (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

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alexandria University, Faculty of nursing

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1532020

Identifier Type: -

Identifier Source: org_study_id

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