【ChiCTR2500114232】Effect of Combined Stress Ball and Lavender Oil on Pain and Anxiety during Arteriovenous Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

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基本信息

登记号

ChiCTR2500114232

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-12-09

临床申请受理号

靶点

适应症

End-stage renal disease (ESRD) on maintenance hemodialysis

试验通俗题目

Effect of Combined Stress Ball and Lavender Oil on Pain and Anxiety during Arteriovenous Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

试验专业题目

Effect of Combined Stress Ball and Lavender Oil on Pain and Anxiety during Arteriovenous Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

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联系人邮编

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临床试验信息

试验目的

1.To evaluate the effect of a combination stress ball and lavender oil on pain during arteriovenous cannulation in hemodialysis patients. 2.To evaluate the effect of a combination stress ball and lavender oil on anxiety during arteriovenous cannulation in hemodialysis patients.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Simple randomization was used based on the pre-assigned hemodialysis schedule. Patients attending sessions on Saturday, Monday, and Wednesday were allocated to the intervention group, while those dialyzing on Sunday, Tuesday, and Thursday were assigned to the control group. The allocation process was not influenced by the researcher; the distribution was determined naturally by the dialysis unit schedule. A nurse from the dialysis unit, who was not involved in the intervention or outcome assessment, supervised the grouping process to ensure unbiased and independent allocation.

盲法

Single-blind (participant-blind) study. Participants were unaware of their group allocation, while the nurse collecting outcome data was not involved in delivering the intervention to ensure unbiased assessment.

试验项目经费来源

Self-funded by the investigator

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-12-08

试验终止时间

2026-03-07

是否属于一致性

入选标准

1. The subject must be 18 years of age or older. 2. Be receiving regular and continuous hemodialysis sessions via a valid vascular access (fistula) at least three months 3. Be able to understand the study details, provide informed consent, and accurately report their own pain or anxiety levels. 4. Have sufficient physical ability to use a stress ball in the hand or limb opposite their vascular access site. 5. Have no known allergies to lavender oil or its carrier ingredient. They must also be free of any active respiratory conditions that could be affected by inhaling the scent.；

排除标准

1. Have a history of allergic reactions to lavender oil or any components of the preparation used in this study. 2. Have an active infection or severe complication at the vascular access site, or any other unstable medical condition that could place the participant at increased risk. 3. Taking painkillers, sedatives, or anti-anxiety medications during three-hour prior HD 4. Severe cognitive impairment, severe psychiatric disorder, or language impairment that impedes informed consent or reliable self-reporting. 5. Physical inability to use a stress ball (such as amputation or paralysis), or any other condition that the study administrators deem a contraindication to participation.；

研究者信息

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试验机构

College of Nursing, University of Baghdad

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