ShotBlocker and Helfer Technique in the Management of Pain and Fear During Hormone Injection in Patients With Breast Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Pain Level
研究概览
简要总结
This randomized controlled study will compare the effects of the ShotBlocker device and the Helfer Skin Tap Technique on pain and fear during intramuscular hormone injections in premenopausal and postmenopausal breast cancer patients. Ninety-nine participants will be randomly assigned to three groups (ShotBlocker, Helfer, control). All injections will be administered by the same nurse using standardized procedures. Pain will be assessed with the Visual Analog Scale, and fear with the Injection Fear Scale. The study aims to identify effective nonpharmacological methods to enhance patient comfort, support treatment adherence, and improve nursing care quality.
详细描述
Objective This study aims to comparatively evaluate the effects of the ShotBlocker device and the Helfer Skin Tap Technique on pain and fear during intramuscular (IM) injection of premenopausal and postmenopausal hormone medications used in breast cancer patients. The study aims to increase patient comfort, support treatment compliance, and improve the quality of nursing care.
Type of Research This research will be conducted using a randomized controlled experimental design. Participants will be randomly assigned to three groups: the ShotBlocker group, the Helfer Skin Tap Technique group, and the control group.
Location and Time of the Study The study will be conducted in the oncology unit of Batman Training and Research Hospital between February and April 2026.
Participants/Sample The study population consists of premenopausal and postmenopausal breast cancer patients who apply to the hospital for hormone injection during the specified dates. Power analysis calculated a minimum of 93 patients; considering possible losses, a total of 99 patients is targeted. Participants will be distributed equally among the groups (ShotBlocker=33, Helfer=33, Control=33).
Method / Intervention ShotBlocker Group: The ShotBlocker device will be placed in the gluteal region prior to injection.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years.
- •Patients diagnosed with breast cancer.
- •Requirement of intramuscular (IM) injection of premenopausal or postmenopausal hormonal medications as part of their prescribed treatment.
- •Cognitive competence to provide informed consent for the injection procedure. Intact skin integrity and normal sensory perception at the injection site (gluteal region).
排除标准
- •History of chronic pain disorders, neuropathic pain syndrome, or any disease requiring regular analgesic use.
- •Presence of neurological or cognitive disorders that may alter pain or fear perception.
- •Use of analgesics within the last 24 hours (or a specific timeframe relevant to your study).
研究组 & 干预措施
ShotBlocker Group
Shotblocker Group: The Shotblocker device will be positioned at the gluteal injection site using aseptic techniques immediately before the administration of hormonal medications. Standard intramuscular (IM) injection protocols will be followed while the device is in situ to mitigate injection-related pain.
干预措施: ShotBlocker device (Device)
Helfer Skin Tap Technique Group
Helfer Skin Tap Group: Rhythmic skin tapping will be performed at points near the gluteal injection site immediately before and during the procedure. Standard intramuscular (IM) injection of hormonal medications will be administered following the Helfer Skin Tap protocol to reduce procedural pain and muscle tension.
干预措施: This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site. (Procedure)
Control Group
Control Group: Standard intramuscular (IM) injection of hormonal medications will be administered to participants in this group without any supportive technique. The procedure will follow routine clinical nursing protocols.
结局指标
主要结局
Pain Level
时间窗: Immediately after injection
Pain will be measured using the Visual Analog Scale (VAS) immediately after intramuscular hormone injection in premenopausal and postmenopausal breast cancer patients. Higher scores indicate higher pain levels.
Injection Fear Scale
时间窗: The scale will be administered twice: immediately before the injection (baseline) and immediately after the injection.
The scale developed by Yıldız and Çiftçi (2023) will be used to assess the fear levels of participants regarding the injection procedure. The scale consists of 14 items, rated on a 5-point Likert scale (1 = No fear, 5 = Extreme fear). The total score is calculated as the mean of the item scores, ranging from a minimum of 1 to a maximum of 5. Higher scores indicate higher levels of injection-related fear. The Cronbach's alpha coefficient of the scale was reported as 0.92 in the original study.
次要结局
未报告次要终点
研究者
Zeliha CENGİZ
Associate Professor
Inonu University