Peppermint Aroma and Physiological Parameters

NCT05541809 | Completed

• 1 other identifier: 1532020
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

Peppermint group

EXPERIMENTAL

This group will receive peppermint oil aroma

Other: Aromatherapy

Water group

PLACEBO COMPARATOR

This group will receive water as an aroma oil

Other: Placebo

Interventions

Aromatherapy OTHER

Peppermint aroma inhalation

Peppermint group

Placebo OTHER

Water inhalation

Water group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University, Faculty of nursing

Alexandria, 21523, Egypt

Location

MeSH Terms

Interventions

Aromatherapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 15, 2022
• Study Start: June 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 30, 2022
• Last Updated: October 24, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)