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

Official title

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

Overview

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.

Interventions

• 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
• 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 inj

Primary outcome measures

• Pain Level [Time frame: Immediately after injection]
• Injection Fear Scale [Time frame: The scale will be administered twice: immediately before the injection (baseline) and immediately after the injection.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Batman Training and Research Hospital — Batman

Publications

• Yaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528. PMID 22033000
• Agac E, Gunes UY. Effect on pain of changing the needle prior to administering medicine intramuscularly: a randomized controlled trial. J Adv Nurs. 2011 Mar;67(3):563-8. doi: 10.1111/j.1365-2648.2010.05513.x. Epub 2010 Dec 28. PMID 21198801
• Cocoman A, Murray J. Intramuscular injections: a review of best practice for mental health nurses. J Psychiatr Ment Health Nurs. 2008 Jun;15(5):424-34. doi: 10.1111/j.1365-2850.2007.01236.x. PMID 18454829
• Malkin B. Are techniques used for intramuscular injection based on research evidence? Nurs Times. 2008 Dec 16-2009 Jan 12;104(50-51):48-51. PMID 19165987
• Small SP. Preventing sciatic nerve injury from intramuscular injections: literature review. J Adv Nurs. 2004 Aug;47(3):287-96. doi: 10.1111/j.1365-2648.2004.03092.x. PMID 15238123
• Ordu Y, Polat HT, Kucukceran K. Effects of cold needle and ShotBlocker applied in the emergency department on pain and satisfaction in intramuscular injection pain: A randomized controlled trial. Australas Emerg Care. 2025 Sep;28(3):157-162. doi: 10.1016/j.auec.2025.02.001. Epub 2025 Feb 8. PMID 39924365
• Savci C, Ozkan B, Aciksari K, Solakoglu GA. Effectiveness of Two Different Methods on the Perceived Pain and Satisfaction During Intramuscular Antibiotic Injection: ShotBlocker and Local Vibration. Clin Nurs Res. 2022 Jun;31(5):812-819. doi: 10.1177/10547738211051877. Epub 2021 Oct 11. PMID 34628979

Identifiers

NCT: NCT07406165 · INONU-BC-2026-01 · 9222

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗