"The Effectiveness of Helfer Skin Tap Technique and ShotBlocker in Reducing Pain Severity During Intramuscular Injections in Adolescent Dysmenorrhea: A Randomized Controlled Trial"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Reduction in Pain Perceived During Injection Using Helfer Skin Tap and ShotBlocker Techniques
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
"In this study, both the participants and the investigators are aware of the intervention being applied. Participants in the Helfer Skin Tap Technique (HSTT) group, ShotBlocker group, and control group are informed about the specific treatment they receive."
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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.
Arms & Interventions
1. Helfer Skin Tap Technique Group
This group will receive the Helfer Skin Tap Technique (HSTT) as a non-pharmacological pain management intervention during intramuscular injection for dysmenorrhea. The effectiveness of this technique in reducing pain will be evaluated.
Intervention: Halfer Skin Tape Technique (Behavioral)
2.ShotBlocker Technique Group
This group will receive the ShotBlocker technique during intramuscular injection for dysmenorrhea as a non-pharmacological pain management intervention. The effectiveness of this technique in reducing pain will be evaluated.
Intervention: ShotBlocker Technique (Behavioral)
3. Control Group
This group will receive a standard intramuscular injection (IM) without any additional pain management technique. The pain intensity in this group will be compared to the other intervention groups.
Intervention: Standard Intramusculer injection (Other)
Outcomes
Primary Outcomes
Reduction in Pain Perceived During Injection Using Helfer Skin Tap and ShotBlocker Techniques
Time Frame: within 5 minutes post-injection, 10 minutes, 30 minutes
Reduction in Pain Intensity During Injection Using Helfer Skin Tap and ShotBlocker Techniques Pain intensity will be measured immediately after the intramuscular injection using the Visual Analog Scale (VAS), which ranges from 0 ("no pain") to 10 ("worst pain imaginable").
Secondary Outcomes
No secondary outcomes reported
Investigators
Duygu MEZDE
Principal Investigator
Ondokuz Mayıs University