Breast CancerNCT07406165
Nonpharmacological Management of Pain and Fear During Hormone Injection in Breast Cancer Patients
A study testing ShotBlocker device and This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site. in people with Breast Cancer and Pain Management, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Pain Management, Fear
- What is being tested?
- ShotBlocker device and This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Batman Training and Research Hospital
Batman, Center
+90(488)2213065, batmandhs5@saglik.gov.tr
About this study
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
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.
Read the 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
- Being tested
- ShotBlocker device, This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.
- Keywords
- Breast cancer, Hormone therapy, Intramuscular injection, Pain, Injection fear
- Medical subject headings
- Breast Neoplasms, Agnosia, Iatrophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlocker deviceDevice
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.Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The scale will be administered twice: immediately before the injection (baseline) and immediately after the injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406165
- Sponsor's protocol ID
- INONU-BC-2026-01
- Other IDs
- 9222
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 22033000Agac 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.
PubMed 21198801Cocoman 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.
PubMed 18454829Malkin B. Are techniques used for intramuscular injection based on research evidence? Nurs Times. 2008 Dec 16-2009 Jan 12;104(50-51):48-51.
PubMed 19165987Small 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.
PubMed 15238123Ordu 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.
PubMed 39924365Savci 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.
PubMed 34628979
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07406165
- Acronym / sponsor ID
- INONU-BC-2026-01
- Conditions
- Breast Cancer, Pain Management, Fear, Injection Fear, Injection Pain Prevention
- Keywords
- Breast cancer, Hormone therapy, Intramuscular injection, Pain, Injection fear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker Group | Experimental | Device: ShotBlocker deviceShotblocker 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. |
| Helfer Skin Tap Technique Group | Active comparator | Procedure: This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShotBlocker deviceParticipants 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. | Device | ShotBlocker Group |
| 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. | Procedure or surgery | Helfer Skin Tap Technique Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 22033000Yaray 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.
- Background: PubMed 21198801Agac 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.
- Background: PubMed 18454829Cocoman 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.
- Background: PubMed 19165987Malkin B. Are techniques used for intramuscular injection based on research evidence? Nurs Times. 2008 Dec 16-2009 Jan 12;104(50-51):48-51.
- Background: PubMed 15238123Small 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.
- Background: PubMed 39924365Ordu 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.
- Background: PubMed 34628979Savci 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShotBlocker device and This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site. in people with Breast Cancer and Pain Management, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeliha Cengiz, Associate Professor (+905433277494, zeliha.cengiz@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Immediately after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07406165, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.