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NCT Number: NCT05541809

Peppermint Aroma and Physiological Parameters

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.

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Key information

Conditions

Mechanical Ventilation Complication

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of nursing

Alexandria, 21523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy

Other

Peppermint aroma inhalation

Placebo

Other

Water inhalation

Primary outcomes

  1. Heart rate

    Time frame: Change from baseline heart rate at one hour.

    The number of heart beats in one minute. It will be reported in beat per minute.

  2. Respiratory rate

    Time frame: Change from baseline respiratory rate at one hour.

    The number of breaths in one minute. It will be reported in breath per minute.

  3. Mean blood pressure

    Time frame: 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).

  4. Pain score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 15, 2022
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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