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临床试验/NCT07063498
NCT07063498尚未招募不适用

The Effect of Fake Coughing and Stress Ball Application on Pain During Bone Marrow Aspiration and Biopsy

Firat University0 个研究点目标入组 80 人开始时间: 2026年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
Pain Intensity During Bone Marrow Aspiration and Biopsy

研究概览

简要总结

Hematology patients go through many difficult periods during the diagnosis process. One of the most commonly used methods in the diagnosis of hematological diseases is bone marrow aspiration and biopsy (BMAB). BMAB is an invasive procedure and may cause pain in patients. For this purpose, a local anesthetic agent is used during the procedure. However, no effective method has been developed to prevent pain in patients. Both pharmacological and non-pharmacological methods are used to manage pain. Among non-pharmacological methods, cognitive distraction techniques such as feigned coughing and stress balls are used to reduce pain and stress. Some studies have reported that "fake coughing" reduces pain during procedures that cause temporary, sharp pain, such as parenteral injections or venipuncture. A literature review revealed that patients undergoing bone marrow aspiration and biopsy experience intense stress and pain, but there are insufficient studies examining these concepts. This study is expected to contribute to the nursing literature. The aim of this study is to determine the effect of fake coughing and stress ball application on pain during bone marrow aspiration and biopsy.

详细描述

Hematology patients go through many difficult periods during the diagnostic process. One of the most commonly used methods in the diagnosis of hematological diseases is bone marrow aspiration and biopsy (BMAB). BMAB is an important examination performed to reveal the cellular characteristics of the bone marrow and the involvement of solid organs or hematological malignancies when there is suspicion in peripheral blood. This procedure plays an important role in the diagnosis of primary and secondary malignant diseases as well as hematological diseases. It can also assist in the staging and sometimes diagnosis of lymphoproliferative diseases, the investigation of unexplained fever, and the diagnosis of disseminated fungal infections and storage diseases. Furthermore, bone marrow aspirations and biopsies have proven useful in detecting non-hematological malignancies in cases where malignancies are not clinically suspected. When both procedures are performed simultaneously, they complement each other, providing more material to examine the morphology and distribution pattern of cells. BMB can be performed in both inpatient and outpatient settings. The posterior iliac crest is the preferred and most common target site for KİAB due to its superficial location, technical ease, and the absence of critical structures along the needle path. The excellent safety profile and high diagnostic yield of KİAB have been established in the literature, making this intervention a critical component of patient management in contemporary medical practice.

Due to its invasive nature, KİAB may cause pain in patients. For this purpose, a local anesthetic agent is used during the procedure. However, no effective method has been developed to prevent pain in patients. In addition to pain, these patients may experience anxiety symptoms such as worry and uncertainty before the procedure. The literature acknowledges the lack of information on pain reduction during the KİAB procedure. Since the importance of more information in this area is recognized, there are no clear guidelines on how to use data on pain-causing factors to prevent or manage pain in patients undergoing this type of biopsy. Nevertheless, the limited studies conducted to reduce procedure-related pain have not changed clinical practice, and pain continues to be a significant burden for many hematological patients.

There are many independent factors that have been investigated in relation to pain in KİAB. These include gender, age, body mass index (BMI), educational level, pre-procedure knowledge, previous KİAB experience, KİAB indication, KİAB site, operator experience, duration, and procedure difficulty. When considering separate characteristics such as BMI, age, or operator experience, study results are often inconsistent. The correlation between procedure duration and difficulty and pain has been documented in various studies. Both pharmacological and non-pharmacological methods are used in pain management. Among non-pharmacological methods, cognitive distraction techniques such as feigned coughing and stress balls are used to reduce pain and stress.

Some studies have reported that "fake coughing" reduces pain during procedures that cause temporary, sharp pain, such as parenteral injections or venipuncture. In this technique, the patient is instructed to cough during the injection or venipuncture procedure. There are several theories about how this maneuver reduces pain, including distraction, stimulation of the autonomic nervous system (coughing has been theorized for this purpose), and increased pressure activating segmental pain-blocking pathways in the subarachnoid space .

It is noted that stress is a result of being unable to cope with emotional or physical threats, and that a person's mental health is closely and directly related to perceived stress. Although there are many methods for reducing stress, it is thought that a stress ball, which is inexpensive and easily accessible, can be used as a method of distracting or redirecting attention. The use of stress balls during minimally invasive venous surgery has been found to reduce anxiety and pain levels.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with cancer at least 3 months ago
  • •Over 18 years of age
  • •Able to communicate adequately
  • •No psychiatric problems
  • •Willing to participate in the study

排除标准

  • •Patients with communication problems
  • •Patients with psychiatric problems

研究组 & 干预措施

Cough Group

Experimental

Voluntary Coughing Maneuver

干预措施: Coughing Maneuver (Behavioral)

control phase

No Intervention

Patients undergo biopsy without any additional intervention.

Stress Ball Group

Experimental

Stress Ball Intervention

干预措施: Stress ball (Behavioral)

结局指标

主要结局

Pain Intensity During Bone Marrow Aspiration and Biopsy

时间窗: Immediately after the procedure.

Patient-reported pain intensity during bone marrow aspiration and biopsy procedures measured by a 10-point Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain imaginable.

次要结局

未报告次要终点

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gui Dural

PhD

Firat University

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