The Effect of Distraction Techniques Used in Intramuscular (IM) Injections on Pain in Adolescents… (NCT06842329) | Clinical Trial Compass
RecruitingNot Applicable
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
Turkey (Türkiye)90 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Pain Perceived During Injection Using Helfer Skin Tap and ShotBlocker Techniques
Timeframe: within 5 minutes post-injection, 10 minutes, 30 minutes