NCT07406165

Nonpharmacological Management of Pain and Fear During Hormone Injection in Breast Cancer Patients

ShotBlocker and Helfer Technique in the Management of Pain and Fear During Hormone Injection in Patients With Breast Cancer: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Inonu University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. Helfer Skin Tap Technique Group: Points close to the injection site will be stimulated with rhythmic taps prior to injection. Control Group: The standard IM injection protocol will be applied. All injections will be administered by the same nurse, using the same technique, in a standardized manner. Pain will be assessed using the Visual Analog Scale (VAS) after the injection, and fear will be assessed using the Injection Fear Scale before and after the injection. Data Collection Tools Individual Identification Form: Participants' demographic characteristics and injection history. Injection Fear Scale: 14-item Likert-type scale, 1-5 point range. Visual Analog Scale (VAS): Measurement of pain level after injection using a 0-10 cm line. Expected Results/Significance The study is expected to determine and compare the effectiveness of ShotBlocker and the Helfer Technique in reducing injection-related pain and fear. The results have the potential to support the use of nonpharmacological methods in clinical practice, thereby increasing patient comfort, ensuring treatment compliance, and improving the quality of nursing care.

Conditions

• Breast Cancer
• Pain Management
• Fear
• Injection Fear
• Injection Pain Prevention

Interventions

Type	Name	Description
DEVICE	ShotBlocker device	Participants in this group will receive intramuscular (IM) injections of premenopausal or postmenopausal hormonal medications. Immediately prior to the procedure, the Shotblocker device (a plastic, butterfly-shaped tool with blunt contact points) will be applied to the gluteal muscle injection site following aseptic techniques. The device will be pressed firmly against the skin to saturate the sensory signals through the gate control mechanism. While the device is in place, the IM injection will be administered according to standard clinical protocols. The device will be removed once the injection is completed and the needle is withdrawn.
PROCEDURE	This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.	Participants in this group will receive intramuscular (IM) injections of premenopausal or postmenopausal hormonal medications. Prior to and during the injection, the Helfer Skin Tap (HST) technique will be applied. This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site. The tapping starts just before the needle insertion and continues rhythmically to promote muscle relaxation and utilize the gate control theory of pain management. The IM injection will be administered according to standard clinical protocols while maintaining the rhythmic tapping.

Timeline

• Start date: 2026-02-10
• Primary completion: 2026-05-30
• Completion: 2026-07-01
• First posted: 2026-02-12
• Last updated: 2026-02-13

Locations

1 site across 1 country: Turkey (Türkiye)