Dysmenorrhea"HSTT-SB DysmeNCT06842329
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
A study testing Halfer Skin Tape Technique, ShotBlocker Technique and Standard Intramusculer injection in people with Dysmenorrhea and Pain, run by Duygu MEZDE at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Dysmenorrhea, Pain, Distraction Methods
- What is being tested?
- Halfer Skin Tape Technique, ShotBlocker Technique and Standard Intramusculer injection
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ladik Devlet Hastanesi
Samsun, 55760
About this 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"
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.
Read more
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.
Read the 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:
- 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.
- Second Hypothesis (H₂): The group using the ShotBlocker will experience lower pain intensity during the intramuscular injection compared to the control group.
- Third Hypothesis (H₃): The group receiving Helfer Skin Tap Technique (HSTT) will experience lower pain intensity compared to the group using the ShotBlocker technique.
- 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.
- Conditions
- Dysmenorrhea, Pain, Distraction Methods
- Being tested
- Halfer Skin Tape Technique, ShotBlocker Technique, Standard Intramusculer injection
- Keywords
- helfer skin tap, shotblocker, pain management
- Medical subject headings
- Dysmenorrhea, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halfer Skin Tape TechniqueBehavioural
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 TechniqueBehavioural
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 injectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Standard Intramusculer injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: within 5 minutes post-injection, 10 minutes, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Oct 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duygu MEZDE
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Sponsor-investigator, Duygu MEZDE, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842329
- Sponsor's protocol ID
- E-26521195-604.01-256976619
- Other IDs
- not yet assignet
- Acronym
- "HSTT-SB Dysme
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "IPD will not be shared due to privacy and confidentiality concerns. All participant data will be anonymized and kept confidential in accordance with ethical guidelines and institutional review board (IRB) requirements. Additionally, there are no plans to share the data with other researchers as it is not necessary for the goals of this study."
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT06842329
- Acronym / sponsor ID
- "HSTT-SB Dysme / E-26521195-604.01-256976619
- Conditions
- Dysmenorrhea, Pain, Distraction Methods
- Keywords
- helfer skin tap, shotblocker, pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Duygu MEZDEUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Second Hypothesis (H₂): The group using the ShotBlocker will experience lower pain intensity during the intramuscular injection compared to the control group.
- Third Hypothesis (H₃): The group receiving Helfer Skin Tap Technique (HSTT) will experience lower pain intensity compared to the group using the ShotBlocker technique.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1. Helfer Skin Tap Technique Group | Experimental | Behavioral: Halfer Skin Tape TechniqueThis 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. |
| 2.ShotBlocker Technique Group | Experimental | Behavioral: ShotBlocker TechniqueThis 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. |
| 3. Control Group | Placebo comparator | Other: Standard Intramusculer injectionThis 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Halfer Skin Tape TechniqueHelfer 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. | Behavioural | 1. Helfer Skin Tap Technique Group |
| ShotBlocker TechniqueShotBlocker 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. | Behavioural | 2.ShotBlocker Technique Group |
| Standard Intramusculer injectionThe 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 | Other | 3. Control Group |
Primary outcome
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").
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- 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 usinLink provided by the sponsor.
- 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 controlleLink provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. "IPD will not be shared due to privacy and confidentiality concerns. All participant data will be anonymized and kept confidential in accordance with ethical guidelines and institutional review board (IRB) requirements. Additionally, there are no plans to share the data with other researchers as it is not necessary for the goals of this study."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Halfer Skin Tape Technique, ShotBlocker Technique and Standard Intramusculer injection in people with Dysmenorrhea and Pain, run by Duygu MEZDE at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duygu Mezde, MSN (+905418848596, duygu.mezde@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Pain Perceived During Injection Using Helfer Skin Tap and ShotBlocker Techniques (time frame: within 5 minutes post-injection, 10 minutes, 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.