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Use of Inhaler Aromatherapy During SWL

Primary Purpose

Pain, Procedural, Aromatherapy, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavender essential oil
Sponsored by
Mersin Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Procedural focused on measuring aromatherapy, lavender, frankincense

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Barış Saylam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo group

lavender group

frankincense group

Arm Description

Only a saline solution was applied to the placebo group

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

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

Outcomes

Primary Outcome Measures

VAS score
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.
Discomfort Intolerance Scale-Revised (DIS-R)
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.
STAI form
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

Secondary Outcome Measures

Full Information

First Posted
April 9, 2021
Last Updated
April 13, 2021
Sponsor
Mersin Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04848350
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural, Aromatherapy, Anxiety
Keywords
aromatherapy, lavender, frankincense

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Only a saline solution was applied to the placebo group
Arm Title
lavender group
Arm Type
Active Comparator
Arm Description
The lavender essential oil was added to the nebulizer and operated on in the SWL room before the procedure,
Arm Title
frankincense group
Arm Type
Active Comparator
Arm Description
The frankincense essential oil was added to the nebulizer and operated on in the SWL room before the procedure,
Intervention Type
Other
Intervention Name(s)
Lavender essential oil
Other Intervention Name(s)
frankincense essential oil
Intervention Description
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
Primary Outcome Measure Information:
Title
VAS score
Description
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.
Time Frame
10 minutes
Title
Discomfort Intolerance Scale-Revised (DIS-R)
Description
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.
Time Frame
10 minutes
Title
STAI form
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erim Erdem, Prof.
Organizational Affiliation
Mersin University Scholl of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barış Saylam
City
Mersin
State/Province
Mezitli
ZIP/Postal Code
33240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27878109
Citation
Barati F, Nasiri A, Akbari N, Sharifzadeh G. The Effect of Aromatherapy on Anxiety in Patients. Nephrourol Mon. 2016 Jul 31;8(5):e38347. doi: 10.5812/numonthly.38347. eCollection 2016 Sep.
Results Reference
background
PubMed Identifier
32267044
Citation
Cai H, Xi P, Zhong L, Chen J, Liang X. Efficacy of aromatherapy on dental anxiety: A systematic review of randomised and quasi-randomised controlled trials. Oral Dis. 2021 May;27(4):829-847. doi: 10.1111/odi.13346. Epub 2020 May 26.
Results Reference
background
PubMed Identifier
32874088
Citation
Tabatabaeichehr M, Mortazavi H. The Effectiveness of Aromatherapy in the Management of Labor Pain and Anxiety: A Systematic Review. Ethiop J Health Sci. 2020 May;30(3):449-458. doi: 10.4314/ejhs.v30i3.16.
Results Reference
background
PubMed Identifier
30205934
Citation
Jaruzel CB, Gregoski M, Mueller M, Faircloth A, Kelechi T. Aromatherapy for Preoperative Anxiety: A Pilot Study. J Perianesth Nurs. 2019 Apr;34(2):259-264. doi: 10.1016/j.jopan.2018.05.007. Epub 2018 Sep 8.
Results Reference
result
PubMed Identifier
29547610
Citation
Ozkaraman A, Dugum O, Ozen Yilmaz H, Usta Yesilbalkan O. Aromatherapy: The Effect of Lavender on Anxiety and Sleep Quality in Patients Treated With Chemotherapy. Clin J Oncol Nurs. 2018 Apr 1;22(2):203-210. doi: 10.1188/18.CJON.203-210.
Results Reference
result
PubMed Identifier
32663929
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.
Results Reference
result

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Use of Inhaler Aromatherapy During SWL

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