ShotBlocker and Helfer Technique in the Management of Pain and Fear During Hormone Injection in Patients With Breast Cancer: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Inonu University
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Pain Level
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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).
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Outcomes
Primary Outcomes
Pain Level
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Zeliha CENGİZ
Associate Professor
Inonu University