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

February 11, 2026 updated by: Zeliha CENGİZ, Inonu University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after injection
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.
The scale will be administered twice: immediately before the injection (baseline) and immediately after the injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INONU-BC-2026-01
  • 9222 (Other Identifier: Inonu University Health Sciences Scientific Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect the privacy and confidentiality of the study participants. The informed consent and ethical approval obtained for this study do not cover the public sharing of raw individual-level data with third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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