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

NCT07406165 | Not Yet Recruiting

• 2 other identifiers: INONU-BC-2026-019222
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear; Injection Fear; Injection Pain Prevention; Breast Cancer; Pain Management

Keywords

Breast cancer; Hormone therapy; Intramuscular injection; Pain; Injection fear

Outcome Measures

Primary Outcomes (2)

• Pain Level

  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.

  Immediately after injection

• Injection Fear Scale

  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.

  The scale will be administered twice: immediately before the injection (baseline) and immediately after the injection.

Study Arms (3)

ShotBlocker Group

EXPERIMENTAL

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.

Device: ShotBlocker device

Helfer Skin Tap Technique Group

ACTIVE COMPARATOR

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.

Procedure: This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.

Control Group

NO INTERVENTION

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.

Interventions

ShotBlocker device 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.

ShotBlocker Group

This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site. PROCEDURE

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.

Helfer Skin Tap Technique Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Batman Training and Research Hospital

Batman, Center, Turkey (Türkiye)

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Agnosia; Iatrophobia; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zeliha Cengiz, Associate Professor

CONTACT

+905433277494; zeliha.cengiz@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to three parallel groups: ShotBlocker, Helfer Skin Tap Technique, and Control. Each group will receive only its assigned intervention during the study period.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)