Inhaled Lavender Applied at Hemodialysis Patients and Effect on Pain, Comfort, and Anxiety

NCT04666363 | Completed

• 1 other identifier: 20978
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The procedure of puncturing during needle insertion and moving needles within the tissues, the insertion angle, diameter of needles, and insertion techniques all lead the patient to experience pain. However, patients tolerate needle insertion more easily when the pain is managed well. Therefore, pharmacological and non-pharmacological methods are needed in pain control in order to improve comfort when undergoing hemodialysis (HD), and to facilitate patient's compliance to treatment over a longer period. Being one of the non-pharmacological practices, aromatherapy is a part of phototherapy, which means "therapy with plants" and also aims to manage symptoms such as pain as well as the treatment itself.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (3)

• Change from baseline invasive pain at one month

  It will be assessed at the end of the dialysis session with Visual Analogue Scale. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. The high point describes bad outcome

  Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))

• Change from baseline comfort at one month

  It will be assessed first dialysis session and at the end of the 12th dialysis session by the nurse. The lowest point is one, the highest point is five. The high point describes good comfort

  Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))

• Change from baseline anxiety at one month

  It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.

  Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))

Study Arms (2)

Lavender oil

EXPERIMENTAL

On the first day (before intervention), the intensity of needle insertion-related pain was measured. The experimental group inhaled lavender essence (12 consecutive hemodialysis seasons).

Other: Lavender oil

Control group

NO INTERVENTION

The patients will not smell lavender oil.

Interventions

Lavender oil OTHER

the essence was diluted 1:10 with sweet almond oil. A cotton ball soaked in 3 drops of diluted lavender essence was kept at a 10 cm distance from the patients' nose and they were asked to breathe slowly for 5 min.

Lavender oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• On maintenance hemodialysis three times per week for four hours per session
• Receiving hemodialysis therapy for a least six moths at the time of the study
• Having the ability to smell
• Able to communicate in Turkish
• Willing to participate to the study

You may not qualify if:

• years of age younger
• Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis
• Pregnant women, patients with a history of allergies, respiratory diseases, neuropathy and peripheral vascular diseases
• Administered with painkillers in the past 3 hours
• Having infection at the fistula area
• Requiring more than one attempt for fistula puncturing
• Unwilling to to participate to the study

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (3)

• Jafari-Koulaee A, Moosazadeh M, Bagheri Nesami M, Goudarzian AH. Effect of cryotherapy on arteriovenous fistula puncture-related pain in hemodialysis patients: A systematic review and meta-analysis. Complement Ther Med. 2020 Mar;49:102326. doi: 10.1016/j.ctim.2020.102326. Epub 2020 Jan 22.

  PMID: 32147063 BACKGROUND

• Bouya S, Ahmadidarehsima S, Badakhsh M, Balouchi A, Koochakzai M. Effect of aromatherapy interventions on hemodialysis complications: A systematic review. Complement Ther Clin Pract. 2018 Aug;32:130-138. doi: 10.1016/j.ctcp.2018.06.008. Epub 2018 Jun 13.

  PMID: 30057040 BACKGROUND

• Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.

  PMID: 28070420 BACKGROUND

MeSH Terms

Interventions

lavender oil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: February 15, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)