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

2026年5月6日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

-

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:対照群
実験的:Helfer Skin Tap Technique applied before IM Diclofenac injection
Helfer Skin Tap Technique applied before IM Diclofenac injection

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Visual Analog Scale (VAS) Score for Pain
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Comfort Levels Assessed by Visual Analog Scale (VAS) Immediately and 5 Minutes After Ventrogluteal Intramuscular Injection
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月20日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2028年1月1日

試験登録日

最初に提出

2026年1月21日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月13日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2025/387
  • E-51301208-605-298988011 (その他の識別子:Republic of Türkiye, Yalova Provincial Directorate of Health)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

The study process may vary depending on the workload.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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