Use of Inhaler Aromatherapy During SWL

April 13, 2021 updated by: Barıs Saylam, Mersin Training and Research Hospital

The Effect of Inhaler Lavender and Frankincense Aromatherapy on Pain and Anxiety in Patients Undergoing SWL.

The study aims to determine the effects of inhalation aromatherapy on pain and anxiety during the SWL protocol. This study included 120 patients who were scheduled to undergo SWL. Patients were randomly assigned a control placebo group 1 (n=40), the lavender group 2 (n=40), and the frankincense group 3 (n=40). The nebulizer (a rate of 2%) was prepared and operated on in the SWL room before the procedure. Data were collected using the visual analog scale (VAS) and the State Anxiety Inventory (STAI-I).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Shock Wave Lithotripsy (SWL) is widely and effectively used in the treatment of urinary tract stone disease. In the first applied lithotriptors, the energy density and maximum energy application at the skin level revealed the need for anesthesia in terms of pain. Later, with the development of new devices, the physics parameters were changed and shock was applied with lower energy levels, using large ellipsoids, the area where shock waves enter the skin is reduced and anesthesia is restricted. During the SWL procedure, patients can identify pain in the form of a subjective sensation that is difficult to identify. Pain occurs for two reasons. The first is the trauma caused by shock waves moving towards the kidney as they pass through the skin and muscles, and the second is the deep organ pain due to the trauma caused by shock waves in the kidney Also, various patient-related and environmental factors affecting pain should be considered. The sedation of patients greatly facilitates SWL tolerance. However, it has been noted in various studies that patients with anxiety experience more pain during SWL. Aromatherapy is a TAT (Tapas Acupressure technique) method in which essential oils created from fragrant parts of plants are absorbed from the body and show their effects. The therapeutic, disease-relieving or preventive properties of essential oils are utilized. Essential oils can be applied to the body by topical, internal, oral, and inhalation methods. The fastest and easiest way of entry of essential oils into the body is inhalation. When applied through breathing, evaporating molecules reach the olfactory bulb through the nose and the limbic system in the brain. Aromatherapy provides control of pain and anxiety by affecting the amygdala and hippocampus, which regulate fear and aggressive behaviors in the limbic system. Aromatherapy by Inhaler is used in hemodialysis, dental procedures, intrauterine contraceptive placement, pain and anxiety control in patients with arthritis. The literature shows that Lavender (lavandula officinalis) and Frankincense (Boswellia) essential oils are used in pain and anxiety management in procedural pain and anxiety control.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Mezitli
      • Mersin, Mezitli, Turkey, 33240
        • Barış Saylam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing SWL
  • Ages between 18-60

Exclusion Criteria:

  • Patients with pain before the procedure (VAS value is non-zero)
  • Patients with respiratory disease (lung cancer, asthma, bronchitis, chronic obstructive pulmonary disease, etc.),
  • patients using painkillers in the last 3 hours,
  • patients who were disturbed by the smell of used essential oils
  • patients with a known allergy to used essential oils with a history of contact dermatitis against cosmetic odor.
  • Patients who used anxiolytic agents and narcotics were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
Only a saline solution was applied to the placebo group
Other: Lavender essential oil
Aromatherapy agents were added to the nebulizer at a rate of 2% (120 ml of water).The nebulizer was prepared and operated on in the SWL room before the procedure, The patients were taken to the room 5 minutes before the procedure and the nebulizer was operated on during the procedure
Other Names:
  • frankincense essential oil
Active Comparator: lavender group
The lavender essential oil was added to the nebulizer and operated on in the SWL room before the procedure,
Other: Lavender essential oil
Aromatherapy agents were added to the nebulizer at a rate of 2% (120 ml of water).The nebulizer was prepared and operated on in the SWL room before the procedure, The patients were taken to the room 5 minutes before the procedure and the nebulizer was operated on during the procedure
Other Names:
  • frankincense essential oil
Active Comparator: frankincense group
The frankincense essential oil was added to the nebulizer and operated on in the SWL room before the procedure,
Other: Lavender essential oil
Aromatherapy agents were added to the nebulizer at a rate of 2% (120 ml of water).The nebulizer was prepared and operated on in the SWL room before the procedure, The patients were taken to the room 5 minutes before the procedure and the nebulizer was operated on during the procedure
Other Names:
  • frankincense essential oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 10 minutes
Patients ' pain levels were measured using the VAS pain scale. This is a horizontal scale, ranging from 0 (no pain) on the left side to 10 (most severe pain) on the right side. Pain intensity can be categorized as mild (score, 1-3), moderate (score, 4-6), and severe (score, 7-10) according to the scale.
10 minutes
Discomfort Intolerance Scale-Revised (DIS-R)
Time Frame: 10 minutes
The scala assesses the perceived inability to tolerate physical discomfort, beliefs about physical discomfort, and responses to feelings of physical discomfort. The DIS-R consists of nine items (e.g., "I can't handle feeling physical discomfort") rated on a 7-point Likert-type scale (0=not at all like me to 6=extremely like me) with higher scores indicating greater discomfort intolerance. Confirmatory factor analysis revealed that the revised 9-item version was a good fit to the data and demonstrated good construct validity in both symptomatic (i.e., clinically-elevated levels of depression or anxiety) and non-symptomatic samples.
10 minutes
STAI form
Time Frame: 10 minutes
The STAI form was used to determine the transitory emotional state and anxiety level of the participants after the procedure. This scale, consisting of 20 items, uses a 4-point Likert scale in which items are scored from 1 (not at all) to 4 (very much). The assessment of the inventory is based on the total score ranging from 20 to 80. A score from1 to 20 is considered to indicate no anxiety, a score of 21 to 40 indicates mild anxiety, a score of 41 to 60 indicates moderate anxiety, and a score of 61 and higher indicates severe anxiety
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin Training and Research Hospital

Investigators

  • Principal Investigator: Erim Erdem, Prof., Mersin University Scholl of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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