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

Hemodialysis Clinical Trial

Official title:

Evaluation of the Effectiveness of Long-term Inhaled Lavender Applied to Hemodialysis Patients on Invasive Pain Experienced During Cannulation, Patient Comfort, and Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666363
• Other study ID #: 20978
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: August 2021
• Source: Istanbul Demiroglu Bilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients. In this regard, in various studies, different pharmacological and non-pharmacological approaches have been used to alleviate the pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 18 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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Other:
• Lavender oil
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.

Locations

Country	Name	City	State
Turkey	Demiroglu Bilim University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View Citation

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. Erratum in: Complement Ther Med. 2020 Mar;49:102363. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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))
Primary	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))