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临床试验/NCT07825974
NCT07825974进行中(未招募)不适用

Effect of Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain During Needle Insertion and Anxiety in Hemodialysis Patients

University of Baghdad1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2026年8月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
190
试验地点
1
主要终点
Pain Intensity Measured by Visual Analogue Scale (VAS)

研究概览

简要总结

This randomized controlled trial aims to evaluate the effect of deep breathing relaxation combined with lemongrass aromatherapy on pain during arteriovenous fistula needle insertion and anxiety in hemodialysis patients. Participants will be randomly assigned to receive either the combined relaxation intervention or standard care. Pain intensity and anxiety levels will be assessed before and after needle insertion.

详细描述

Hemodialysis patients experience recurrent pain and anxiety during arteriovenous fistula cannulation, which can negatively affect treatment adherence and quality of life. Non-pharmacological interventions such as deep breathing relaxation and aromatherapy have shown potential in reducing procedure-related pain and anxiety. Lemongrass (Cymbopogon citratus) essential oil contains citral and other compounds with reported anxiolytic and analgesic properties. However, the combined effect of deep breathing relaxation with lemongrass aromatherapy has not been well studied in this population. This study will recruit hemodialysis patients who require arteriovenous fistula cannulation. The intervention group will receive deep breathing relaxation instruction combined with lemongrass aromatherapy inhalation before needle insertion. The control group will receive standard care. The primary outcomes are pain intensity measured by the Visual Analogue Scale (VAS) and anxiety measured by the State-Trait Anxiety Inventory (STAI). Secondary outcomes include physiological parameters (heart rate, blood pressure) and patient satisfaction. Data will be collected during three consecutive hemodialysis sessions to assess consistency of effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • receiving hemodialysis three times per week for at least 3 months; stable arteriovenous fistula or graft access; baseline pain score ≥4 on the Visual Analog Scale (VAS) during previous cannulation; ability to understand and perform breathing exercises; and willingness to participate.

排除标准

  • (1)known allergy to lemongrass or essential oils; (2) history of asthma or severe respiratory disease; (3) cognitive impairment or psychiatric disorders; (4) use of analgesic or anxiolytic medications within 24 hours prior to intervention; (5) active infection or skin lesions at the access site; and (6) pregnancy or lactation

研究组 & 干预措施

expermental

Experimental

Participants receive deep breathing relaxation instruction combined with lemongrass essential oil inhalation for a specified duration before each needle insertion, across three hemodialysis sessions.

干预措施: Deep Breathing Relaxation (Behavioral)

expermental

Experimental

Participants receive deep breathing relaxation instruction combined with lemongrass essential oil inhalation for a specified duration before each needle insertion, across three hemodialysis sessions.

干预措施: Lemongrass Aromatherapy (Other)

control

No Intervention

Participants receive standard care and routine needle insertion procedure without the study interventions

结局指标

主要结局

Pain Intensity Measured by Visual Analogue Scale (VAS)

时间窗: Immediately after needle insertion, during three consecutive hemodialysis sessions

VAS score (0-100 mm, where 0 = no pain and 100 = worst imaginable pain) assessed immediately after needle insertion.

Anxiety Measured by State-Trait Anxiety Inventory (STAI)

时间窗: Before and immediately after needle insertion

State anxiety subscale score of the STAI, a validated 20-item self-report instrument. Higher scores indicate greater anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maitham abed Shawwat

Dr. Maitham Abed Shawwat (PhD)

University of Baghdad

研究点 (1)

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