Evaluation of the Effectiveness of Long-term Inhaled Lavender Applied to Hemodialysis Patients on Invasive Pain Experienced During Cannulation, Patient Comfort, and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from baseline invasive pain at one month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline invasive pain at one month
时间窗: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
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
Change from baseline comfort at one month
时间窗: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
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
Change from baseline anxiety at one month
时间窗: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
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.
次要结局
未报告次要终点
研究者
Nurten Ozen
Associate Professor
Istanbul Demiroglu Bilim University