CClinicalTrials.gg
Active, not recruitingNCT07583472Updated May 13, 2026

Impact of the Helfer Skin Tap Technique on Pain and Comfort Levels During Ventrogluteal Injection: A Randomized Controlled Trial

An interventional study of Helfer Skin Tap Technique applied before IM Diclofenac injection in PAIN, ANXIETY, AND COMFORT, sponsored by Seyda Can. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Seyda Can · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This randomized controlled study evaluates the effect of the Helfer Skin Tap Technique on pain and comfort during ventrogluteal intramuscular injections in adults.

Participants aged 18-65 receiving diclofenac sodium injections at the Emergency Department of Yalova Training and Research Hospital will be randomly assigned to the intervention group (Helfer technique) or control group (standard injection). Pain and comfort will be measured using visual analog scales (VAS) before and after the injection.

The study aims to provide evidence for improving injection pain management and patient comfort. Participation is voluntary, and all procedures follow ethical guidelines.

Read the detailed description

The implementation of high-risk treatments and interventions in healthcare has increasingly highlighted the concept of patient safety in recent years. Patient safety is an indicator of quality in healthcare services and has become one of the fundamental elements of providing qualified and high-quality care (Korkmaz, 2018). The growing complexity of healthcare services, changing healthcare needs, and rapid technological advancements in the field introduce multiple risks for both healthcare professionals and patients (Yıldız \& Yıldız, 2020).

In the healthcare process, after medications are prescribed by the physician, nurses administer these drugs and are responsible for preparing the correct medication and delivering it to the right patient, at the right time, via the right route, in the correct dose, and for monitoring its effects (Apaydın \& Öztürk, 2021). Medications can be administered via oral, topical, or parenteral routes (Turan et al., 2019). Parenteral drug administration, one of the important medication routes, involves invasive procedures and carries multiple risks (Okuroğlu et al., 2019).

Intramuscular (IM) injection, one of the parenteral routes, has been used in nursing practice for over a century and is applied by delivering the drug into deep muscle tissue (Korkmaz et al., 2018). Because muscles have a rich vascular supply, IM injections allow better absorption of the drug (Turan et al., 2019). Accordingly, the absorption and bioavailability of drugs via IM injection are higher compared to oral or other parenteral routes (Ayinde et al., 2021). IM injections require nurses to have strong knowledge in anatomy, physiology, and pharmacology, as well as good psychomotor skills (Eraydın \& Karagözoğlu, 2022). Additionally, determining needle depth, syringe length, and injection speed is highly important (Turan et al., 2019).

If IM injections are not properly administered, they can cause nerve (sciatic nerve), muscle, vascular, and bone injury; abscess, erythema, scar tissue formation, hematoma, bleeding, persistent pain, cellulitis, tissue necrosis, granuloma, muscle fibrosis, contracture, and infection (Eraydın \& Karagözoğlu, 2022; Tok Aydın, 2019). Nerve damage can occur directly from needle impact or indirectly due to edema or hematoma at the injection site, which exerts mechanical pressure on the nerve, or via diffusion of the drug into the nerve causing toxic effects. Antibiotics and analgesics are the most frequent causes (Bostan, 2016). The World Health Organization reports that approximately 12 billion injections are administered globally each year, with 50% given unsafely (Turan et al., 2019). Therefore, safety in IM injection administration is critically important (Turan et al., 2019).

After IM injection, pain at the injection site, anxiety, fear, dissatisfaction, or loss of privacy can reduce the acceptability of treatment for patients. Awareness that IM injections are painful may affect clinicians' preference for this route. Despite this, due to its importance in treatment, pain at the injection site remains a key concern (Ayinde et al., 2021; Eraydın \& Karagözoğlu, 2022).

When individuals experience pain, how the painful stimulus is transmitted to the brain, perceived, and responded to is influenced by socio-cultural factors such as family, gender, age, anxiety, previous pain experiences, race, culture, and ethnicity (Shah \& Narayanan, 2016). Injection-related fear and anxiety are commonly encountered by nurses, and supporting patients during IM injections can reduce pain and anxiety (Eraydın \& Karagözoğlu, 2022).

Pain management in healthcare settings is a fundamental component of nursing care, and nurses must be competent in this area, as it is part of their professional responsibility (Shah \& Narayanan, 2016). A systematic review examining pain management during IM injections found that techniques such as manual pressure, Helfer Skin Tap Technique, post-injection massage, acupressure, air-lock technique, and ice application may be potentially effective in reducing injection pain (Ayinde et al., 2021).

Nurses are expected to apply interventions based on evidence, and the ventrogluteal region is preferred for IM injection due to its safety (Tosunöz, 2023). Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used medications for pain, fever, and inflammation, with diclofenac sodium being one of the widely prescribed analgesics, used to treat inflammatory diseases, dysmenorrhea, and other conditions (Çiltaş, 2014; Bhadra et al., 2016). IM administration of 75 mg diclofenac sodium reaches peak plasma levels within approximately 20 minutes (Çiltaş, 2014).

Previous studies have used the Helfer Skin Tap Technique with various drugs and samples (Shaban et al., 2021; Güven \& Çalbayram, 2023; Kurt et al., 2024). However, there is insufficient evidence on the effect of the technique on pain and comfort during IM diclofenac sodium injection. This study was therefore designed to evaluate the effectiveness of the Helfer Skin Tap Technique on pain and comfort during IM diclofenac injection in the ventrogluteal region (Tosunöz, 2023).

The study aims to determine the effectiveness of the Helfer Skin Tap Technique, with the expectation that the findings will contribute to evidence-based nursing practices, reduce injection-related pain, improve patient comfort, and positively influence treatment adherence and quality of life.

02

Conditions studied

  • PAIN, ANXIETY, AND COMFORT

Keywords

  • Pain, Comfort,İntramusculer injection,patience,nurse,helfer skin tape
03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

This is the only study on the registry with Seyda Can as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Individuals who can speak and understand Turkish,

Individuals who are willing to participate in the study and have provided written informed consent,

Aged between 18 and 65 years,

Body Mass Index (BMI) between 18-24 kg/m²,

Individuals without sensory-motor deficits, diabetes, peripheral vascular disease, or neuropathy,

Individuals who have not received oral or parenteral analgesic treatment before the injection,

Individuals without ecchymosis, redness, or swelling at the injection site,

Individuals without orthopedic issues preventing internal rotation of extremities,

Individuals with intact orientation to time and place,

Individuals without visual or hearing impairments.

Exclusion criteria

Exclusion Criteria:

Individuals who refuse to undergo the technique applied within the study after being enrolled,

Individuals who voluntarily withdraw from the study,

Individuals for whom less than 24 hours have passed since their last injecti

-

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Helfer Skin Tap Technique applied before IM Diclofenac injection

    Helfer Skin Tap Technique applied before IM Diclofenac injection

    Behavioral: Helfer Skin Tap Technique applied before IM Diclofenac injection

  • No intervention
    Control Group

    Control Group

Interventions

  • BehavioralHelfer Skin Tap Technique applied before IM Diclofenac injection

    Helfer Skin Tap Technique applied before IM Diclofenac injection

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale (VAS) Score for Pain

    Description: Patient's pain level Time Frame: From the initiation of the intramuscular injection until the completion of the procedure

    Time frame: Immediately (0 minute) and 5 minutes after the intramuscular injection.

Secondary outcomes

  1. Comfort Levels Assessed by Visual Analog Scale (VAS) Immediately and 5 Minutes After Ventrogluteal Intramuscular Injection

    Description: Patient Comfort Level Description: patient's comfort level

    Time frame: Time Frame: Immediately (0 minute) and 5 minutes after the intramuscular injection.

07

Study locations

1 site
  • Yalova University
    Yalova, Yalova 77100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided — The study process may vary depending on the workload.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07583472
Lead sponsor
Seyda Can
Collaborators
Yalova training and research hospital
Responsible party
Seyda Can (Associate Professor, PhD, University of Yalova) — Sponsor-investigator
First posted
May 13, 2026
Start date
Jan 20, 2026
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
May 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion