Clinical trial NCT04848350: Use of Inhaler Aromatherapy During SWL
Official title: The Effect of Inhaler Lavender and Frankincense Aromatherapy on Pain and Anxiety in Patients Undergoing SWL.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural
Aromatherapy
Anxiety
Keywords: aromatherapy
lavender
frankincense
Lead sponsor: Mersin Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS score
timeFrame: 10 minutes
measure: Discomfort Intolerance Scale-Revised (DIS-R)
timeFrame: 10 minutes
measure: STAI form
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Barış Saylam
state: Mezitli
Study officials:
affiliation: Mersin University Scholl of Medicine
name: Erim Erdem, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gong M, Dong H, Tang Y, Huang W, Lu F. Effects of aromatherapy on anxiety: A meta-analysis of randomized controlled trials. J Affect Disord. 2020 Sep 1;274:1028-1040. doi: 10.1016/j.jad.2020.05.118. Epub 2020 May 26.