Use of Inhaler Aromatherapy During SWL

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-09-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pain, Procedural Aromatherapy Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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placebo group

Only a saline solution was applied to the placebo group

Group Type PLACEBO_COMPARATOR

Lavender essential oil

Intervention Type OTHER

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

lavender group

The lavender essential oil was added to the nebulizer and operated on in the SWL room before the procedure,

Group Type ACTIVE_COMPARATOR

Lavender essential oil

Intervention Type OTHER

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

frankincense group

The frankincense essential oil was added to the nebulizer and operated on in the SWL room before the procedure,

Group Type ACTIVE_COMPARATOR

Lavender essential oil

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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frankincense essential oil

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes