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

NCT07583472 | Active Not Recruiting DMC

• 2 other identifiers: 2025/387E-51301208-605-298988011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PAIN, ANXIETY, AND COMFORT

Keywords

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

Outcome Measures

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

  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

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

Study Arms (2)

Helfer Skin Tap Technique applied before IM Diclofenac injection

EXPERIMENTAL

Helfer Skin Tap Technique applied before IM Diclofenac injection

Behavioral: Helfer Skin Tap Technique applied before IM Diclofenac injection

Control Group

NO INTERVENTION

Control Group

Interventions

Helfer Skin Tap Technique applied before IM Diclofenac injection BEHAVIORAL

Helfer Skin Tap Technique applied before IM Diclofenac injection

Helfer Skin Tap Technique applied before IM Diclofenac injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seyda Can: lead
• Yalova training and research hospital: collaborator

Study Sites (1)

Yalova University

Yalova, Yalova, 77100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this study, only the participants are blinded to their group assignment. No other parties (such as the administering nurse or data analysts) are blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: May 13, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-01

Locations

TU (1)