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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemodialysis

Intervention / Treatment
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* Other: Lavender oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender oil<br>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<br>* 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.<br>|
| No Intervention: Control group<br>The patients will not smell lavender oil. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) |