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

NCT06842329 | Recruiting

• 2 other identifiers: E-26521195-604.01-256976619not yet assignet
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea; Pain; Distraction Methods

Keywords

helfer skin tap; shotblocker; pain management

Outcome Measures

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").

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

Study Arms (3)

1. Helfer Skin Tap Technique Group

EXPERIMENTAL

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.

Behavioral: Halfer Skin Tape Technique

2.ShotBlocker Technique Group

EXPERIMENTAL

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.

Behavioral: ShotBlocker Technique

3. Control Group

PLACEBO COMPARATOR

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.

Other: Standard Intramusculer injection

Interventions

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.

1. Helfer Skin Tap Technique Group

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.

2.ShotBlocker Technique Group

Standard Intramusculer injection OTHER

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

3. Control Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duygu MEZDE: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Ladik Devlet Hastanesi

Samsun, 55760, Turkey (Türkiye)

RECRUITING

Related Links

• This study was conducted to evaluate the effects of ShotBlocker and Palm Stimulator, developed by researchers, on reducing pain during intramuscular injections in 7-10 years old children.Material and Method: The study was conducted with three groups usin
• The Effect of Buzzy Method on Reducing Pain During Intramuscular Injection in Children. Hasan Kalyoncu University, Graduate Education Institute, Department of Nursing, Master Thesis, Gaziantep, 2022. There search was carried out as a randomized controlle
• The effects of vibration and pressure methods on the level of fear, anxiety, and pain of pediatric patients who were admitted to the emergency department for intramuscular injection were evaluated.
• The study purpose was to determine the decrease of dysmenorrhea pain rate after being given abdominal stretching exercise on nursing students at STIKES TanawaliPersada, Takalar, Indonesia.

MeSH Terms

Conditions

Dysmenorrhea; Pain; Agnosia

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Duygu Mezde, MSN

CONTACT

+905418848596; duygu.mezde@hotmail.com

Esra Tural Büyük, Prof Dr

CONTACT

+905052795196; esratural55@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: "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."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 24, 2025
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)