An interventional study of Multisensory stimulation in Multisensory Stimulation, Pain and Venipuncture Pain, sponsored by Bilecik Seyh Edebali Universitesi. Suspended at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Bilecik Seyh Edebali Universitesi · Not applicable, Interventional, and Health services research
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Among 1,714 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 1,714 studies in Pain with a site in Turkey, this one is the 704th largest by planned enrollment of the 1,491 interventional ones that give a count, is one of 280 that started in 2025, is one of 1,449 with no phase, and was the 1,646th registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →322 of the 1,714 studies in Pain with a site in Turkey are open now. Recruiting first, the newest first:
Mersin University · Sites in Turkey
Ages 18+
Artvin Coruh University · Sites in Turkey
Ages 6–12
Mersin University · Sites in Turkey
Ages 18+
Bahçeşehir University · Sites in Turkey
Ages 45–65
Istanbul University · Sites in Turkey
Ages 1–12
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: 5 Years to 10 Years · all sexes · healthy volunteers too.
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1,714 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. 280 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is close to the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 70 across the 1,491 interventional studies, 84 across the 223 observational. Of the 1,270 that completed or were terminated, 7 (1%) have results posted.
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4 of 1,714 have an industry lead sponsor. The 10 most frequent:
Bilecik Seyh Edebali Universitesi is the lead sponsor of 62 studies on the registry; 27 are open to participants now.
Bilecik Seyh Edebali Universitesi has 3 studies filed under Pain — fewer than ten, so there is no comparison to draw.
85 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 |
Add all 85 to your calendar (.ics) → With an account.
Among the 1,714 studies in Pain with a site in Turkey, from their registry updates:
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Venipuncture is one of the most common and distressing needle-related procedures for children, often causing significant pain, fear, and anxiety. To minimize this procedural distress, effective non-pharmacological interventions are essential in pediatric nursing care.
Children encounter many situations in the hospital environment that trigger pain, fear, and anxiety. The unfamiliarity of the physical environment, the appearance of medical devices, interventions by healthcare professionals, and the unpredictability of routine procedures are cited as important factors that increase children's levels of pain, fear, and anxiety. Children with chronic illnesses, in particular, face numerous painful procedures during diagnosis, treatment, and follow-up, while healthy children also experience pain due to reasons such as venipuncture and repeated invasive procedures. Venipuncture, one of the most commonly used and fundamental procedures in healthcare delivery, can be a traumatic experience, especially for children.This procedure can cause intense pain, anxiety, and fear in children, leading to negative psychological reactions in the short term and the development of negative attitudes toward healthcare services in the long term.The literature indicates that such negative attitudes not only adversely affect the success of the procedure but also manifest themselves in the child as physical resistance, crying, avoidance behavior, and increased physiological stress indicators.These behavioral and physiological responses can lead to problems for healthcare professionals, such as prolonged procedure times, multiple attempts, and increased procedural complexity; this situation can cause anxiety for both the child and the healthcare worker. Furthermore, it has been reported that negative experiences during painful procedures such as venipuncture can lead to psychosocial consequences in children, including long-term fear, avoidance of medical procedures, needle phobia, and the formation of traumatic memories. The high levels of anxiety and fear experienced by children during this process can reduce their compliance with healthcare services in later years and lead to mistrust of healthcare professionals. Numerous studies in the literature have determined that the anxiety and fear experienced by children during venipuncture are among the key factors that significantly affect the quality of the procedural process .Therefore, reducing pain, fear, and anxiety that may develop during venipuncture in children is critically important for both protecting the child's short- and long-term well-being and increasing the effectiveness of clinical practice. Although venipuncture is a painful medical procedure, it is one of the situations that causes significant anxiety and fear in children in a hospital setting.Research in the literature on non-pharmacological methods to control pain and reduce anxiety and fear suggests the use of multisensory stimulation to distract children and create a happy and motivating atmosphere.
Multisensory stimulation is a non-pharmacological method that aims to support a child's developmental stages using stimulating materials targeting the senses of sight, hearing, smell, and touch, with the goal of reducing behavioral problems, pain, and fear.The basic mechanism of multisensory stimulation is to provide multiple stimuli by continuously activating the tactile, thermal, and emotional systems. This simultaneous stimulation of various sensory systems leads to sensory saturation. This activates the gate control mechanism to close the gates, thereby weakening or suppressing nociceptive transmission. Thus, the gate control mechanism reduces or eliminates pain by closing the gates to prevent the entry of nociceptive signals. Multiple sensory stimulation practices include mother-infant communication, skin-to-skin contact, breastfeeding that activates skin sensory receptors and the sense of taste, and allowing the infant to smell familiar scents such as breast milk, amniotic fluid, or aromatic scents. Establishing eye contact with the infant, speaking in a soft tone of voice, massage, swaddling, and using the parent's scent are also among the multisensory stimulation practices.
Non-pharmacological methods are known to be effective in reducing pain in children and to increase the effectiveness of medications when used in combination with analgesics.Non-pharmacological methods are preferred because they are easy to apply and inexpensive, reducing the need for medication and thus the risk of side effects. Knowing the effects of pain and the associated fear and anxiety on children, developing appropriate pain control strategies is both a medical and ethical responsibility. A review of the literature reveals that there is very little scientific evidence that multisensory stimulation is an effective intervention for reducing pain, fear, and anxiety in children during venipuncture.Recent research in the literature on non-pharmacological methods for pain control and reducing anxiety and fear recommends the use of multisensory stimulation in children. Some studies have examined the effects of multisensory stimulation applications on children's health. These studies have mostly focused on the effects during the neonatal period.Although there are a limited number of studies aimed at reducing pain, fear, and anxiety during venipuncture in children, these studies are limited to methods that focus on only one sense or at most two sensory stimuli.Therefore, our study contributes to the limited literature evaluating the effect of multisensory stimulation by using Happy Senso Therapy foam, which simultaneously stimulates the senses of touch, sight, hearing, and smell. In this context, the aim of our study is to examine the effect of multisensory stimulation applied during venipuncture in children on pain, anxiety, and fear.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A Randomized Controlled Trial
Other: Multisensory stimulation
Happy Senso Therapy foam is a gel with multisensory properties. It stimulates the senses of touch, sight, hearing, and smell simultaneously in a fun way. It is a material used for sensory stimulation. It provides a cooling and fun effect that feels like "popping candy" on your skin. It evaporates at the end of the ses-sion, leaving no residue. It does not require washing. It has been dermatologically tested. It is paraben-free and hypoallergenic. It is used in therapy applications, as a work, play, and educational material. It is noted to be useful for increasing the child's attention span to the ac-tivity, boosting motivation, and reducing pain and fear. It helps increase interaction between the nurse and the child.
Child's Pain Level
Wong Baker Facial Pain Rating Scale The scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 2013. This scale is used to assess pain in children aged 3-18 years. The scale is rated from 0 to 10. 0 indicates no pain, while 10 indicates the most severe pain. Pain is assessed based on facial expression.
Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Child's Anxiety Level
It assesses children's anxiety in clinical settings and before medical procedures. The Child Anxiety Meter (CAM) is drawn like a thermometer with a bulb at the bottom and also contains horizontal lines spaced upward. Children are asked to mark how they feel "right now" to measure state anxiety (CAM-S).Scores range from 0 to 10. It has been validated in children aged 4-10 years during an intravenous procedure. CAM-S scores were significantly correlated with all parent measures and observed distress ratings. The psychometric properties of CAM in the Turkish population were examined by Özalp Gerçeker and colleagues (2018), who found a significant negative correlation between children's anxiety scores and their age.
Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Child's Fear Level
The Child Fear Scale (CFS), the validity and reliability of which was conducted by Gerçeker et al. (2018), is used to measure the child's anxiety level. The PSS is a 0-4 scale consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to scared face (4=severe anxiety). It can be used by families and researchers to assess pain and anxiety in children before and during the procedure and is intended for children aged 5-10 years (McMurtry et al., 2011). The CQS was created based on the Faces Anxiety Scale developed by McKinley et al. (2003) to measure the fear or anxiety of adults hospitalized in the intensive care unit. It is a scale consisting of one item and five gender-neutral faces. The facial muscle changes in fearful expressions were drawn by a graphic artist based on photographs of the faces. For the ACS, the total size of the Faces Anxiety Scale was reduced to match the size of the Child Anxiety and Pain Scale, but the drawings were not changed.
Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Plan to share: No — Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol. Specifically: Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories. Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity. De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.
Started Oct 2025 (actual). Primary completion is estimated for Aug 2026, 10 months after the start.
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Bilecik Seyh Edebali Universitesi