Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

6 maggio 2026 aggiornato da: Seyda Can

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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:

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

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Gruppo di controllo
Sperimentale: Helfer Skin Tap Technique applied before IM Diclofenac injection
Helfer Skin Tap Technique applied before IM Diclofenac injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analog Scale (VAS) Score for Pain
Lasso di tempo: Immediately (0 minute) and 5 minutes after the intramuscular injection.
Description: Patient's pain level Time Frame: From the initiation of the intramuscular injection until the completion of the procedure
Immediately (0 minute) and 5 minutes after the intramuscular injection.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Comfort Levels Assessed by Visual Analog Scale (VAS) Immediately and 5 Minutes After Ventrogluteal Intramuscular Injection
Lasso di tempo: Time Frame: Immediately (0 minute) and 5 minutes after the intramuscular injection.

Description:

Patient Comfort Level Description: patient's comfort level

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 gennaio 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

21 gennaio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2025/387
  • E-51301208-605-298988011 (Altro identificatore: Republic of Türkiye, Yalova Provincial Directorate of Health)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The study process may vary depending on the workload.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi