Clinical Research Directory

THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE

What is this study about, in short? This study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested: * A nurse lightly and rhythmically tapping with their fingertips just above the spot where the needle will go ("rhythmic skin tapping"). * The child making an "mmmm" humming sound while the blood is being drawn ("internal vibration" or "humming"). These methods need no medicine and no device, so they can be used easily in any hospital. The study aims to find out whether these two methods really reduce pain and fear, by comparing them with a group that receives no extra method. Why is this study being done? Drawing blood is one of the most common painful procedures in children. Fear of needles is very common and can even lead a person to avoid health care later in life. So it matters to make the blood-draw experience easier for children. Some methods used to reduce pain have practical limits: * Numbing creams must be applied 30-60 minutes before the procedure; they are not practical in urgent situations and add cost. * Special devices that give cold and vibration can work, but they can be expensive, are not always available, and need care for hygiene. For these reasons, there is a need for simple methods that cost nothing, need no device, and can be applied easily in any setting. This study tests exactly that. How do the methods work? (Simple science) Both methods rest on an idea called the "Gate Control Theory": in our body, the sense of touch and vibration competes with the sense of pain on the way to the brain. Gentle touch or mild vibration can act like a "gate" that partly blocks the pain signal from reaching the brain. * Rhythmic skin tapping: Gentle, rhythmic tapping with the fingers may help "close the gate," so the pain is felt less. * Internal vibration (humming): The "mmmm" sound creates a mild vibration in the body. It can also stimulate the calming part of the nervous system, which may lower the heart rate and stress. Taking an active part in the procedure also gives the child a sense of control. Who can take part in the study? Can take part: * Children aged 6-12 years * Children who will have a blood draw * Children whose parent has given written permission and who themselves agree verbally * Children who can understand and speak Turkish * Children whose cognitive development is appropriate for their age * Children who do not have an ongoing (chronic) pain condition Cannot take part, or will be withdrawn: * Children who do not want to take part, or wish to withdraw at any stage * Children who develop a complication (an unexpected medical problem) during the procedure * Children who have used a painkiller within the last 24 hours * Children who have already taken part in this study before * Children whose skin is broken at the site where the needle will go * Children who have a neurological or psychiatric diagnosis What will happen if my child takes part? The blood draw will happen anyway because it is medically needed. The study only adds the method used during the draw and a short measurement afterward. Step by step: * Your child is placed by computer, at random (like drawing lots), into one of three groups. No one can choose the group in advance; this is called "randomization" and it keeps the comparison fair. * The blood draw is done as usual. The only difference is the method used, depending on your child's group. * Right after the procedure, the child is shown two short picture scales: one for pain, with faces ranging from smiling to crying (0-10), and one for fear, also made of faces (0-4). * A short form collects details such as age, sex, and any previous blood-draw experience. * No extra needle, medicine, or laboratory test is done beyond the routine blood draw. The three groups are: Group What is done in this group? 1. Rhythmic skin tapping Gentle, rhythmic tapping with the fingertips just above the needle site. 2. Internal vibration (humming) The child is asked to make an "mmmm" humming sound during the blood draw. 3. Control group The blood draw is done as usual, with no extra method. This group is the comparison point used to measure the effect of the other two methods. Where and when will the study take place? * Place: Kepez State Hospital Blood Collection Outpatient Clinic (Antalya, Türkiye). * Data collection period: June 2026 - June 2027. The total study duration is about 12 months. * Planned number of participants: 126 children in total (42 in each group). This number was set in advance by a statistical calculation so the results would be reliable. Taking part is completely voluntary * Your child does not have to take part. Even if you agree, you may withdraw at any time without giving a reason. * Not taking part, or withdrawing, will not affect the health care your child receives in any way. * Your child may also say they do not want the method; the child's decision is

Early vs. Late Tourniquet Release and Phlebotomy-Induced Hemolysis in the Emergency Department: TOURNI-ED

BACKGROUND: Hemolysis is the most common preanalytical error in emergency department (ED) laboratories, affecting 17-26% of blood samples collected in the ED and leading to test cancellations, repeat venipuncture, delayed diagnoses, and increased healthcare costs. Venous stasis created by tourniquet application during phlebotomy is a recognized contributing factor to hemolysis. While clinical guidelines recommend releasing the tourniquet once blood flow is established, the optimal timing of tourniquet release in relation to tube filling sequence has not been systematically evaluated. OBJECTIVE: The primary objective of this trial is to determine whether early release of sphygmomanometer-applied venous stasis (released after the first tube fills) reduces hemolysis rates compared to late release (released after the last tube fills) during routine phlebotomy in ED patients triaged as green or yellow category. DESIGN: Single-center, parallel-group, superiority randomized controlled trial with 1:1 allocation ratio. The trial was prospectively registered prior to the enrollment of the first participant. PARTICIPANTS: Adult patients (≥18 years) presenting to the emergency department with triage category green (semi-urgent) or yellow (urgent), for whom blood collection is indicated as part of routine clinical care. Patients requiring blood collection from an intravenous catheter, those with known coagulation disorders, and those who decline to participate are excluded. INTERVENTIONS: Group A (Early Release): Sphygmomanometer inflated to 60 mmHg for venous stasis; tourniquet released immediately after the first tube (sodium citrate, blue cap) completes filling. Remaining tubes (SST/gel, yellow cap; K2-EDTA, purple cap) are collected after release. Group B (Late Release): Sphygmomanometer inflated to 60 mmHg; tourniquet maintained throughout all tube filling and released only after the last tube (K2-EDTA, purple cap) completes filling. Tube collection order follows the CLSI H03-A6 standard for both groups. PRIMARY OUTCOME: Hemolysis rate, defined as the proportion of serum separator tube (SST/yellow cap) samples with a Hemolysis Index (HI) ≥ 1+ (corresponding to free hemoglobin ≥50 mg/dL), is assessed by the clinical chemistry laboratory analyzer. The outcome assessor (laboratory technician) is blinded to group assignment. SECONDARY OUTCOMES: (1) Distribution of ordinal hemolysis index categories (-, 1+, 2+, 3+, 4+, 5+) in SST samples; (2) Proportion of hemolyzed samples requiring repeat blood collection; (3) Total blood collection duration (seconds) from sphygmomanometer inflation to last tube filling completion; (4) Complication rate (hematoma, nerve injury, vasovagal reaction, arterial puncture, multiple puncture attempts). SAMPLE SIZE: A total of 792 participants (396 per group) are required based on an assumed hemolysis rate of 12% in the late release group and 6% in the early release group (50% relative risk reduction), α=0.05 (two-tailed), 80% power (Fleiss with pooled variance), plus 10% dropout buffer. RANDOMIZATION: Simple randomization using a computer-generated random number list (randomizer.org). The allocation sequence is maintained by a designated person not involved in enrollment or data collection. Allocation is revealed sequentially at the point of care. STATISTICAL ANALYSIS: Primary analysis: Chi-square test comparing hemolysis rates between groups (intention-to-treat population). Secondary analyses: Mann-Whitney U test for ordinal HI distribution; logistic regression for adjusted odds ratio. Bonferroni correction applied to multiple secondary comparisons (adjusted α = 0.017). Per-protocol analysis performed as a sensitivity analysis. Missing data handled using complete case analysis with sensitivity analysis.

Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project

The goal of this clinical trial is to determine if implementing a controlled blood removal protocol (i.e. hypovolemic phlebotomy \[HP\] where approximately 10% of the patient's blood is removed and reinfused following hepatic resection as described in the PRICE-2 clinical trial) will reduce the rate of blood transfusions in liver resection surgery at Kingston Health Sciences Centre. Our goals (not included in the PRICE-2 trial) are as follows: * Improved monitoring of how the body responds during surgery following controlled blood removal. We will conduct blood tests to look at oxygen, carbon dioxide, lactate, and acid (pH) levels in the blood as well as urine output. * Standardized guidelines for how fluids and blood pressure medications are used during surgery to reduce blood loss and keep hemodynamics stable. * Monitor patients' recovery following surgery to track complications, injury to the heart, length of hospital stay, and outcomes for up to 90 days. We will also compare long-term recurrence rate of liver cancer compared to patients in the past at our site who did not receive the controlled blood removal (i.e., HP) prior to surgery.

Autonomous Blood Drawing Optimization and Performance Testing

The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device). The study consists of several phases (A, B1, B2, C1, C2, C3, 0). Phase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawing. Phases A, B2, B3, C1, C2, C3 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection). The study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers can be included in a non-hospital site (Vitestro Site).