Clinical trial NCT04666363: Inhaled Lavender Applied at Hemodialysis Patients and Effect on Pain, Comfort, and Anxiety
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline invasive pain at one month
timeFrame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
measure: Change from baseline comfort at one month
timeFrame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
measure: Change from baseline anxiety at one month
timeFrame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
References:
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.
citation: 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.
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.