An interventional study of ShotBlocker in Pain and Intramuscular Injection, sponsored by Bornova No. 25 Mevlana Family Health Center. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Bornova No. 25 Mevlana Family Health Center · Not applicable, Interventional, and Supportive care
Among 1,712 studies in Pain with a site in Turkey — 322 open to participants now, 372 under way, none of them phase 3. Pain · Turkey.
Among the 1,712 studies in Pain with a site in Turkey, this one is the 98th largest by enrollment of the 1,489 interventional ones that give a count, is one of 81 that started in 2018, is one of 1,447 with no phase, and was the 483rd registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
Browse Pain studies →322 of the 1,712 studies in Pain with a site in Turkey are open now. Recruiting first, the newest first:
Mersin University · Sites in Turkey
Artvin Coruh University · Sites in Turkey
Mersin University · Sites in Turkey
Bahçeşehir University · Sites in Turkey
Istanbul University · Sites in Turkey
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,712 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 6 · Phase 4 34
First in 2006; this study’s year is marked. 81 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 146 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Median enrollment 70 across the 1,489 interventional studies, 84 across the 223 observational. Of the 1,268 that completed or were terminated, 7 (1%) have results posted.
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4 of 1,712 have an industry lead sponsor. The 10 most frequent:
Bornova No. 25 Mevlana Family Health Center is the lead sponsor of 2 studies on the registry; none are open to participants now.
Bornova No. 25 Mevlana Family Health Center has 2 studies filed under Pain — fewer than ten, so there is no comparison to draw.
84 of the studies in Pain with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07707726Ankara City Hospital BilkentVirtual Reality in Ingrown Toenail Surgery | 2026-11-15 |
| NCT07846098Cumhuriyet UniversityComparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars | 2026-11-20 |
| NCT07404163Tarsus UniversityWalkway Used in Postoperative Mobilization | 2026-11-30 |
| NCT07915804Istanbul UniversityPerfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy | 2026-11-30 |
| NCT07892196Antalya Training and Research HospitalDoes Chronic Pain Change Over Time in Children With Duchenne Muscular Dystrophy? | 2026-11-30 |
Among the 1,712 studies in Pain with a site in Turkey, from their registry updates:
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Shotblocker is an effective approach to reduce injection pain. Generally, injection pain has been studied in children, but reducing injection pain in adults is an important issue. This study investigates the effect of ShotBlocker on pain and satisfaction levels associated with diphtheria-tetanus vaccination in pregnant women.
The sample of this prospective, single-blind randomized controlled experimental study consists of 146 pregnant women registered to the Family Health Center between October 2018 and June 2019. Women were assigned to ShotBlocker and control groups with 73 women in each group. The women's pulse rate was taken one minute before the injection by the researcher. In the ShotBlocker group was used ShotBlocker. The control group used the steps of administering a normal intramuscular injection. The pain and satisfaction related to the injection were evaluated using the Visual Analog Scale and Visual Patient Satisfaction Scale after the vaccination. Pulse rates of the women were taken again by the researcher one minute after the injection.
As the rate of vaccination increases, preventable diseases and their negative effects decrease; Nevertheless, the significance of vaccine-related side effects is increasing. The most prevalent complications in vaccine applications are local reactions such as pain, swelling, and erythema at the injection site. The most frequent pain in these reactions develops after diphtheria-tetanus vaccine in which aluminum is used as an adjuvant. Diphtheria-tetanus vaccine is generally administered to the deltoid region by intramuscular injection (IM), and most pregnant women complain about the pain that they experience during and after administration of diphtheria-tetanus vaccine. Nurses have a great responsibility in reducing and eliminating the pain felt by patients during operations. The success of pain management is related to nurses' knowledge and skills. If the pain that an individual will feel due to the piercing of the skin with a needle during intramuscular injection application is decreased or reduced to minimum, the anxiety and fear that the person will experience may abate. Therefore, to reduce pain and anxiety in individuals during injection; nurses use many non-pharmacological methods. ShotBlocker (Bionix, Toledo, OH) is one of the methods that can be used to reduce pain caused by IM injections. This small, flat, U-shaped plastic device used by holding it on the skin surface during injection did not have any side effects. ShotBlocker has a surface of 2 mm thick with rounded nubs to stimulate the skin. The surface of the plastic device is placed on the skin just before the injection; there is a hole in the center where the injection is administered. The rounded nubs on the surface of the plastic device do not damage the skin, these rounded nubs that create a slight pressure provide a warning for the Gate Control Theory. ShotBlocker's mechanism of action is thought to reduce pain by stimulating nerve endings faster with pressure of rounded nubs on the device. This stimulation decreases pain by blocking pain signals temporarily during injections and by inhibiting the central nervous system.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In the ShotBlocker group, ShotBlocker was placed on the previously determined injection site before vaccination, and the vaccination was performed by holding it on the surface of the skin and pressing lightly with the fingertips. All vaccinations were carried out by an experienced nurse. ShotBlocker was removed after removing the needle.
Other: ShotBlocker
In the control group, the steps of administering a normal intramuscular injection were used. Except for this, no additional method was used. All vaccinations were carried out by an experienced nurse.
ShotBlocker (Bionix, Toledo, OH) is one of the methods that can be used to reduce pain caused by IM injections. This small, flat, U-shaped plastic device used by holding it on the skin surface during injection did not have any side effects \[5\]. ShotBlocker has a surface of 2 mm thick with rounded nubs to stimulate the skin (Figure 1). The surface of the plastic device is placed on the skin just before the injection; there is a hole in the center where the injection is administered \[6\]. The rounded nubs on the surface of the plastic device do not damage the skin, these rounded nubs that create a slight pressure provide a warning for the Gate Control Theory \[7\]
Visual analog scale
The VAS is used to assess the severity of acute pain. It is mostly a horizontal or vertical line 100 mm long, starting with "no pain" and ending with "unbearable pain". It is used to convert some values that cannot be measured numerically to a numerically usable form \[10\].
Time frame: 6 month
Visual patient satisfaction scale
The visual patient satisfaction scale combines the characteristics of the well-known VAS. At one end of the scale is the phrase "I am not satisfied at all", and at the other end is the phrase "I am very satisfied".
Time frame: 6 month
Plan to share: No
Ran from Nov 2018 to primary completion in Nov 2018, 0 months.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 0 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Bornova No. 25 Mevlana Family Health Center