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

ConditionsBreast Cancer Pain Management Fear Injection Fear Injection Pain Prevention

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorInonu University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

99 Participants

are divided into 3 treatment groups

Group A: ShotBlocker GroupExperimental treatment 1 intervention

Group B: Helfer Skin Tap Technique GroupActive comparator 1 intervention

Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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

Sponsors and contacts

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Inonu University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: