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).
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
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- 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.
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.
- Conditions
- PAIN, ANXIETY, AND COMFORT
- 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 group | Role | What they receive |
|---|---|---|
| Helfer Skin Tap Technique applied before IM Diclofenac injection | Experimental | Helfer Skin Tap Technique applied before IM Diclofenac injection Receives: Behavioral: Helfer Skin Tap Technique applied before IM Diclofenac injection |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted13 May 2026
- Study start20 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAIN, ANXIETY, AND COMFORTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Seyda Can
- Sponsor type
- University, hospital or other
- Collaborators
- Yalova Training and Research Hospital
- Responsible party
- Sponsor-investigator, Seyda Can, University of Yalova
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Helfer Skin Tap Technique on Pain and Comfort Levels During Ventrogluteal Injection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07583472
- Acronym / sponsor ID
- 2025/387
- Conditions
- PAIN, ANXIETY, AND COMFORT
- Keywords
- Pain, Comfort,İntramusculer injection,patience,nurse,helfer skin tape
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seyda CanUniversity, hospital or other
- Collaborators
- Yalova Training and Research Hospital
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Helfer Skin Tap Technique applied before IM Diclofenac injection | Experimental | Behavioral: Helfer Skin Tap Technique applied before IM Diclofenac injectionHelfer Skin Tap Technique applied before IM Diclofenac injection |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helfer Skin Tap Technique applied before IM Diclofenac injectionHelfer Skin Tap Technique applied before IM Diclofenac injection | Behavioural | Helfer Skin Tap Technique applied before IM Diclofenac injection |
Primary outcome
Visual Analog Scale (VAS) Score for Pain
Time frame: 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
1 secondary outcome
Comfort Levels Assessed by Visual Analog Scale (VAS) Immediately and 5 Minutes After Ventrogluteal Intramuscular Injection
Time frame: Time Frame: Immediately (0 minute) and 5 minutes after the intramuscular injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided. The study process may vary depending on the workload.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.