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Effect of Stress Ball Use on Pain, Anxiety, and Vital Signs During Ultrasound-Guided Tru-cut Biopsy (STRESS-BX)

2026年5月23日 更新者:Yagmur Berktas、Istanbul University

The Effect of Stress Ball Application on Pain, Anxiety, and Vital Signs During Ultrasound-Guided Tru-Cut Biopsy Procedures: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of stress ball application on pain, anxiety, and vital signs in adult patients undergoing ultrasound-guided tru-cut biopsy procedures. Tru-cut biopsy is a commonly performed invasive diagnostic procedure that may cause procedural pain and anxiety despite standard local anesthesia. Nonpharmacological interventions such as distraction techniques may improve patient comfort during the procedure.

Participants are randomly assigned to either an intervention group receiving a stress ball application during the biopsy procedure or a control group receiving standard care alone. Pain intensity is assessed using the Visual Analog Scale (VAS), anxiety levels are evaluated using the State-Trait Anxiety Inventory (STAI Form TX-I), and vital signs are recorded before and after the procedure.

The study is conducted at a single tertiary care training and research hospital and includes 79 adult participants. The primary objective of the study is to determine whether stress ball use reduces procedural pain and anxiety during Tru-Cut biopsy procedures. Secondary outcomes include changes in systolic blood pressure, diastolic blood pressure, heart rate, and procedure duration.

調査の概要

詳細な説明

A Tru-cut biopsy is a minimally invasive diagnostic procedure frequently used to evaluate suspicious lesions and tissue abnormalities. Although local anesthesia is routinely administered, patients commonly experience procedural pain, anxiety, and physiological stress responses during the procedure. Increased anxiety levels may negatively influence pain perception, procedural tolerance, and overall patient experience.

Nonpharmacological interventions have increasingly gained attention as supportive approaches for reducing pain and anxiety during invasive procedures. Among these interventions, distraction techniques are considered practical, low-cost, and easy to implement in clinical settings. Stress ball application is a simple distraction-based intervention that encourages active patient participation and may help redirect attention away from the procedure.

This study was designed as a prospective, single-center, parallel-group randomized controlled trial to evaluate the effect of stress ball application on pain, anxiety, and vital signs during ultrasound-guided Tru-Cut biopsy procedures. Participants were randomly assigned in a 1:1 ratio to either the intervention group, which received stress ball application during the procedure, or the control group, which received standard care alone.

Pain intensity was assessed using the Visual Analog Scale (VAS), and anxiety levels were evaluated using the State-Trait Anxiety Inventory (STAI Form TX-I). Vital signs, including systolic and diastolic blood pressure and heart rate, were recorded before and after the procedure. The study aimed to determine whether the use of stress balls could reduce procedural pain and anxiety and improve physiological responses during Tru-Cut biopsy procedures.

研究の種類

介入

入学 (実際)

79

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Istanbul
      • Istanbul、Istanbul、トルコ(Türkiye)、34000
        • Bakirkoy Dr. Sadi Konuk Training and Research Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

Aged 18 years or older Scheduled for an ultrasound-guided tru-cut biopsy procedure Conscious and able to communicate Able to understand and respond to the study forms Provided written informed consent Patients with or without previous biopsy experience

Exclusion Criteria:

Received sedation prior to the procedure Had cognitive impairment or communication difficulties Had upper extremity limitations preventing stress ball use Experienced complications during the procedure Refused to participate in the study

-

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Experimental: Stress Ball Application

Experimental Arm Description

Participants in the experimental group received stress ball application during the ultrasound-guided tru-cut biopsy procedure in addition to standard care. Patients were instructed to squeeze the stress ball continuously throughout the procedure as a distraction-based nonpharmacological intervention. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure.

Control Arm Description

Participants in the control group received routine standard care during the ultrasound-guided tru-cut biopsy procedure. No additional nonpharmacological intervention was applied. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure.

Participants in the intervention group received stress ball application during the ultrasound-guided tru-cut biopsy procedure in addition to routine standard care. Patients were instructed to continuously squeeze a medium-resistance stress ball throughout the procedure as a distraction-based nonpharmacological intervention aimed at reducing procedural pain and anxiety. The intervention was applied only during the biopsy procedure, and no pharmacological or additional behavioral intervention was administered as part of the study.
介入なし:No Intervention: Standard Care
Participants in the control group received routine standard care during the ultrasound-guided tru-cut biopsy procedure. No additional nonpharmacological intervention or distraction technique was applied. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Post-procedural Pain Intensity
時間枠:Immediately after the procedure
Pain intensity assessed after the ultrasound-guided tru-cut biopsy procedure using the Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.
Immediately after the procedure
Change in State Anxiety Level
時間枠:Before and immediately after the procedure
Change in anxiety level measured using the State-Trait Anxiety Inventory Form TX-I (STAI) before and after the ultrasound-guided tru-cut biopsy procedure. Higher scores indicate higher anxiety levels
Before and immediately after the procedure

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月15日

一次修了 (実際)

2026年4月15日

研究の完了 (実際)

2026年5月15日

試験登録日

最初に提出

2026年5月23日

QC基準を満たした最初の提出物

2026年5月23日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月23日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2026/39
  • BSKEAH-2026-39 (その他の識別子:Bakirkoy Dr. Sadi Konuk Training and Research Hospital)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

米国FDA規制機器製品の研究

いいえ

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