Clinical trial NCT06842329: The Effect of Distraction Techniques Used in Intramuscular (IM) Injections on Pain in Adolescents Presenting to the Emergency Department With Dysmenorrhea: A Randomized Controlled Study
Official title: "The Effectiveness of Helfer Skin Tap Technique and ShotBlocker in Reducing Pain Severity During Intramuscular Injections in Adolescent Dysmenorrhea: A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysmenorrhea
Pain
Distraction Methods
Keywords: helfer skin tap
shotblocker
pain management
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2025-02-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial with a parallel assignment design. Participants will be randomly assigned to one of three groups: the Helfer Skin Tap technique group, the ShotBlocker technique group, and the control group (standard intramuscular injection). The effectiveness of non-pharmacological pain management techniques in reducing dysmenorrhea pain will be compared across these groups.
Primary purpose: TREATMENT

Brief summary: Brief Summary:

This study investigates the effectiveness of non-pharmacological techniques for managing dysmenorrhea (menstrual pain) in adolescents. The study focuses on methods such as Helfer Skin Tap Technique (HSTT) and ShotBlocker, which aim to reduce pain without medication. The goal is to determine how these techniques can help adolescents manage their pain more effectively.

The study targets adolescents aged 12-18 who experience menstrual pain. Participants will be monitored over several months to assess the impact of these techniques on their pain levels, emotional well-being, and daily activities.

Participation in the study poses minimal risks. However, the effectiveness of these pain management techniques may vary from person to person. By the end of the study, the aim is to improve pain management strategies for adolescents and gain a better understanding of the effectiveness of non-pharmacological treatments for dysmenorrhea.

Detailed description: Objective:

The purpose of this study is to evaluate the effectiveness of non-pharmacological pain management techniques, namely the Helfer Skin Tap Technique (HSTT) and ShotBlocker, in reducing pain intensity during intramuscular injections in adolescents who present with dysmenorrhea (menstrual pain) in the emergency department. This study compares these techniques with a control group receiving standard intramuscular (IM) injection procedures.

Study Design:

This is a randomized controlled trial (RCT) designed to assess the pain-reducing effects of two non-pharmacological techniques during intramuscular injections. The study took place at Ladik State Hospital Emergency Department from October 1, 2025, to April 1, 2025. Participants were adolescent girls aged 12-18 years presenting to the emergency department with dysmenorrhea. The study compares the following groups:

* Group 1: Participants who receive Helfer Skin Tap Technique (HSTT).
* Group 2: Participants who use the ShotBlocker device.
* Control Group: Participants who receive standard intramuscular injection without any pain management techniques.

Hypotheses:

1. First Hypothesis (H₁): The group receiving Helfer Skin Tap Technique (HSTT) will experience lower pain intensity during the intramuscular injection compared to the group receiving the ShotBlocker technique and the control group.
2. Second Hypothesis (H₂): The group using the ShotBlocker will experience lower pain intensity during the intramuscular injection compared to the control group.
3. Third Hypothesis (H₃): The group receiving Helfer Skin Tap Technique (HSTT) will experience lower pain intensity compared to the group using the ShotBlocker technique.
4. Fourth Hypothesis (H₄): The control group will experience higher pain intensity compared to the groups receiving Helfer Skin Tap Technique (HSTT) or ShotBlocker.

Study Procedure:

Adolescents aged 12-18 years experiencing dysmenorrhea were randomly assigned to one of three groups: Helfer Skin Tap Technique (HSTT), ShotBlocker, or the control group. The pain intensity during the intramuscular injection was assessed using the Visual Analog Scale (VAS), a widely used method for measuring pain intensity. Pain ratings were recorded immediately after the injection, and follow-up evaluations were conducted to assess the continued effects on pain and emotional well-being.

Expected Outcomes:

We anticipate that both the Helfer Skin Tap Technique and ShotBlocker will reduce pain intensity during the injection, with the Helfer Skin Tap Technique (HSTT) potentially offering the most significant reduction in pain compared to the ShotBlocker and the control group. Secondary outcomes include emotional well-being, quality of life related to menstrual pain, and any adverse events related to the techniques used.

Risk and Safety Considerations:

The risks associated with participation in this study are minimal. The primary risk is mild discomfort or temporary soreness from the techniques being applied, which is rare and usually resolves quickly. All participants will be monitored for any adverse effects during the study. The techniques used, including HSTT and ShotBlocker, are safe, non-invasive, and commonly used in clinical settings.

Data Collection and Analysis:

Pain levels will be measured using the Visual Analog Scale (VAS), and data will be statistically analyzed to compare the effectiveness of each technique. We will evaluate the difference in pain intensity between the three groups and assess the feasibility of these non-pharmacological techniques for managing dysmenorrhea in adolescent girls. Statistical methods, including ANOVA and t-tests, will be employed to analyze the data.

Conclusion:

This study aims to provide evidence on the effectiveness of non-pharmacological pain management techniques, specifically the Helfer Skin Tap Technique (HSTT) and ShotBlocker, in reducing pain intensity in adolescents with dysmenorrhea during intramuscular injections. If successful, the findings could lead to better pain management options for adolescents, offering them drug-free solutions for managing menstrual pain, thus improving their quality of life.

Eligibility criteria: nclusion Criteria:

* Adolescents aged 12-18 years.
* Experience of dysmenorrhea (menstrual pain) during at least one menstrual cycle.
* Adolescents presenting to the emergency department with dysmenorrhea.
* Written informed consent from participants or their legal guardians.

Exclusion Criteria:

* Individuals with severe cardiovascular, neurological, or other serious medical conditions.
* Pregnant individuals.
* Individuals undergoing regular hormonal therapy or using birth control methods.
* Individuals with significant psychological or physiological conditions related to pain sensitivity (e.g., hyperalgesia).
* Individuals receiving other pharmacological treatments or pain management medications during the study.

Primary outcomes:
measure: Reduction in Pain Perceived During Injection Using Helfer Skin Tap and ShotBlocker Techniques
timeFrame: within 5 minutes post-injection, 10 minutes, 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ladik Devlet Hastanesi
Study officials:
References: