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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-18
SponsorDuygu MEZDE

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Halfer Skin Tape Technique

    Behavioral

    Helfer Skin Tap Technique (HSTT) is a non-pharmacological pain management method that involves a series of gentle taps on the skin prior to an intramuscular injection. This technique is intended to distract the patient from the pain of the injection and reduce perceived pain intensity by stimulating different sensory pathways.

  • ShotBlocker Technique

    Behavioral

    ShotBlocker is a non-pharmacological device that applies pressure to the skin at the injection site to disrupt pain signals and reduce the pain perception during intramuscular injections. The pressure stimulates the sensory nerve fibers, which helps block the sharp pain from the needle insertion.

  • Standard Intramusculer injection

    Other intervention

    The control group will receive a standard intramuscular injection without the use of any pain management techniques (such as HSTT or ShotBlocker). This group serves as a baseline to compare the effect

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: 1. Helfer Skin Tap Technique GroupExperimental treatment 1 intervention
Group B: 2.ShotBlocker Technique GroupExperimental treatment 1 intervention
Group C: 3. Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in Pain Perceived During Injection Using Helfer Skin Tap and ShotBlocker Techniques

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").

Time frame
within 5 minutes post-injection, 10 minutes, 30 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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Duygu MEZDE

Lead sponsor

Ondokuz Mayıs University

Sponsor institution

Ondokuz Mayıs University

Collaborator