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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 The device will be removed once the injection is completed and the needle is withdrawn.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Pain Level — 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 — 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.

Trial sites (1)

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