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PAIN, ANXIETY, AND COMFORTNCT07583472

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

A study testing Helfer Skin Tap Technique applied before IM Diclofenac injection in people with PAIN, ANXIETY, AND COMFORT, run by Seyda Can at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
PAIN, ANXIETY, AND COMFORT
What is being tested?
Helfer Skin Tap Technique applied before IM Diclofenac injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jan 2026to Jan 2028
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

  • 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,
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Yalova University

    Yalova, Yalova, 77100

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
Helfer Skin Tap Technique applied before IM Diclofenac injection
Keywords
Pain, Comfort,İntramusculer injection,patience,nurse,helfer skin tape
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Helfer Skin Tap Technique applied before IM Diclofenac injectionBehavioural

    Helfer Skin Tap Technique applied before IM Diclofenac injection

Study groups in NCT07583472
Study groupRoleWhat they receive
Helfer Skin Tap Technique applied before IM Diclofenac injectionExperimentalHelfer Skin Tap Technique applied before IM Diclofenac injection
Receives: Behavioral: Helfer Skin Tap Technique applied before IM Diclofenac injection
Control GroupNo interventionControl Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (1)
  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start20 Jan 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

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 are randomly assigned to one of two parallel groups: one group receives the Helfer Skin Tap Technique prior to injection, and the other group receives the standard injection procedure.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583472
Sponsor's protocol ID
2025/387
Other IDs
E-51301208-605-298988011
Status last verified
Jan 2026
First submitted
21 Jan 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The study process may vary depending on the workload.

Questions about this trial

What is this clinical trial studying?

A study testing Helfer Skin Tap Technique applied before IM Diclofenac injection in people with PAIN, ANXIETY, AND COMFORT, run by Seyda Can 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 May 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) Score for Pain (time frame: Immediately (0 minute) and 5 minutes after the intramuscular injection.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 May 2026.

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