Use of Inhaler Aromatherapy During SWL

NCT04848350 | Completed

• 1 other identifier: 2020376
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Procedural; Aromatherapy; Anxiety

Keywords

aromatherapy; lavender; frankincense

Outcome Measures

Primary Outcomes (3)

• 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.

  10 minutes

• 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.

  10 minutes

• 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

  10 minutes

Study Arms (3)

placebo group

PLACEBO COMPARATOR

Only a saline solution was applied to the placebo group

Other: Lavender essential oil

lavender group

ACTIVE COMPARATOR

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

Other: Lavender essential oil

frankincense group

ACTIVE COMPARATOR

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

Other: Lavender essential oil

Interventions

Lavender essential oil 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

Also known as: frankincense essential oil

frankincense group; lavender group; placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing SWL
• Ages between 18-60

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin Training and Research Hospital: lead

Study Sites (1)

Barış Saylam

Mersin, Mezitli, 33240, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 27878109 BACKGROUND

• 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.

  PMID: 32267044 BACKGROUND

• 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.

  PMID: 32874088 BACKGROUND

• 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.

  PMID: 30205934 RESULT

• 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.

  PMID: 29547610 RESULT

• 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.

  PMID: 32663929 RESULT

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Erim Erdem, Prof.

  Mersin University Scholl of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)