Clinical Research Directory

Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss

This study will examine whether virtual reality can reduce pain and anxiety in women undergoing surgical uterine evacuation after early pregnancy loss at Tarsus State Hospital, Türkiye. Ninety women will be randomly assigned to two groups of 45 participants each. One group will receive virtual reality in addition to routine care, while the other group will receive routine care alone. Researchers will compare pain, anxiety, and vital signs between the groups to assess the effects of virtual reality.

Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children

This single-center, parallel-group, randomized experimental study will compare the effects of two active non-pharmacological interventions - distraction-card use and emotion-regulation toy squeezing - on procedural pain and pain-related fear during intramuscular tetanus vaccination in children aged 4-7 years. Eligible children will be randomized to either the distraction-card group or the emotion-regulation toy-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after the intramuscular injection procedure. Hypotheses * H1a: There is a difference between the groups in mean Wong-Baker FACES scores during the procedure. * H1b: There is a difference between the groups in mean Children's Fear Scale scores during the procedure.

ShotBlocker and Warm Gel Pack During Neonatal Heel Prick (HEAL)

This study evaluated the effects of ShotBlocker and a warm gel pack on pain, comfort, and physiological parameters during heel prick testing in healthy term newborns. A three-arm randomized controlled trial was conducted at a city hospital between October 2024 and October 2025. Newborns were randomly assigned to the ShotBlocker group, warm gel pack group, or routine care group. Pain was assessed using the Neonatal Infant Pain Scale (NIPS), and comfort was assessed using the COMFORTneo. Heart rate, respiratory rate, oxygen saturation, and heel temperature were also measured before and after the procedure. The study aimed to compare the effectiveness of these non-pharmacological interventions during routine heel prick testing.

Effects of Binaural Beats on Pain and Anxiety During Flexible Cystoscopy

This prospective, single-center, three-group clinical study aims to evaluate the effects of binaural beat stimulation on pain and anxiety in adult patients undergoing flexible cystoscopy. A total of 120 patients aged 18 to 80 years are planned to be included. Participants will be evaluated in three groups according to the auditory stimulation received during flexible cystoscopy: 5 Hz theta binaural beats (n = 40), 10 Hz alpha binaural beats (n = 40), and a control group without binaural beat stimulation (n = 40). The primary outcome will be pain intensity during flexible cystoscopy, assessed using the Visual Analog Scale (VAS). Secondary outcomes will include anxiety levels measured using the State-Trait Anxiety Inventory-State (STAI-S) before and after the procedure, as well as patient comfort and satisfaction. The study aims to determine whether binaural beat stimulation may provide a simple, non-invasive approach to improving patient comfort during flexible cystoscopy.

Comparison of Ketorolac and Dexmedetomidine as An Adjunct to Lignocaine in Prevention of Tourniquet Induced Pain During Intravenous Regional Anesthesia

This study compared ketorolac and dexmedetomidine when added to lignocaine to prevent pain caused by a tourniquet during intravenous regional anesthesia. This technique involved injecting a local anesthetic into a vein to numb an arm or leg for surgery. A tourniquet, a tight cuff placed around the limb, restricted blood flow but could cause pain during the procedure. The study was conducted at Mayo Hospital, Lahore, and was designed to include 70 patients aged 18-60 years undergoing surgery on the lower part of an arm or leg. Two treatment groups of 35 patients each received lignocaine with either dexmedetomidine or ketorolac. Pain was assessed on a scale from 0 to 10 at 15, 30, and 45 minutes after tourniquet application. Additional pain relief was administered when the pain score reached 4 or higher.

E-MOHS Trial of TENS and Vibration During Local Anesthesia

The E-MOHS Trial is a randomized controlled trial evaluating whether active vibration plus transcutaneous electrical nerve stimulation reduces pain during local anesthetic infiltration in adults undergoing Mohs micrographic surgery or dermatologic excision. Participants will be randomized to active vibration:TENS or sham TENS during the first local anesthetic administration. The primary outcome is patient-reported infiltration pain during active local anesthetic infiltration, measured using the 11-point Numeric Rating Scale. Secondary outcomes include infiltration pain measured using a Visual Analog Scale, perioperative anxiety, participant satisfaction, willingness to reuse the device, operator-rated ease of use and sterile-field compatibility, blinding integrity, and adverse events.

The Effect of Using a Stress Ball on Pain, Anxiety, and Vital Signs During Breast Biopsy

Breast biopsy is an invasive diagnostic procedure commonly performed for the histopathological diagnosis of breast lesions and can be associated with anxiety and pain. Procedural anxiety and pain may also influence physiological responses, including changes in blood pressure and heart rate. Therefore, non-pharmacological nursing interventions that are simple, low-cost, and easy to implement may be useful in managing procedural distress. This study aims to investigate the effect of stress ball use during breast biopsy on patients' pain, anxiety, and vital signs. Participants will be assigned to an intervention group using a stress ball during the biopsy procedure or a control group receiving standard care. Pain and anxiety levels, as well as vital signs, will be assessed and compared between the two groups.

Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates

Neonates, particularly those hospitalized in neonatal intensive care units (NICUs), are subjected to numerous painful procedures essential for their diagnosis and monitoring. Heel lance, performed for routine blood sampling, stands as one of the most frequently encountered painful experiences for these vulnerable infants, as robust neurobiological evidence confirms that even preterm infants possess the anatomical and functional capacity to perceive pain, manifesting measurable physiological, hormonal, and behavioral responses. The daily average of acute painful events can reach up to 10-15 procedures in the NICU, and repeated exposure to inadequately managed procedural pain has been associated with immediate physiological instability as well as longer-term alterations in stress regulation, somatosensory processing, and neurodevelopmental outcomes. These vulnerabilities are further compounded in preterm and low birth weight infants who require prolonged hospitalization and specialized care.

Stress-Ball Distraction for Pain and Anxiety During Painful Procedures in Critically Ill Patients

This study will examine whether using a small hand-held stress ball during painful procedures can help critically ill adult patients feel less pain and anxiety. Painful procedures may also temporarily increase heart rate, blood pressure, and breathing rate. Participants will be randomly assigned, like flipping a coin, to one of two groups. One group will receive usual care during the procedure. The other group will receive usual care and will be asked to squeeze a stress ball as a distraction technique during the procedure. The study team will measure participants' pain and anxiety before, during, and 15 minutes after the procedure. The team will also record heart rate, blood pressure, respiratory rate, oxygen saturation, procedure-related events, use of additional pain medicine or sedation, and satisfaction with care. The findings may help health care providers understand whether stress-ball distraction is a safe, simple, non-drug method for improving comfort during painful procedures in critically ill patients.

Topical Lidocaine for Digital Nerve Block Pain

The goal of this clinical trial is to determine whether topical lidocaine spray applied to the wound before digital nerve block can reduce injection-related pain in patients with finger lacerations. The study will also evaluate whether topical lidocaine spray affects the success of the nerve block. The main questions it aims to answer are: Does topical lidocaine spray reduce pain during digital nerve block injection? Does topical lidocaine spray improve first-pass success of the digital nerve block? Researchers will compare topical lidocaine spray with a placebo spray to determine whether lidocaine provides better pain control during the procedure. Participants will: Receive either topical lidocaine spray or placebo spray applied to the wound before the digital nerve block. Undergo a standard digital nerve block with lidocaine. Rate their pain during the procedure. Be assessed for block success, procedure duration, satisfaction, willingness to undergo the procedure again if needed, and adverse events.

Intravenous Magnesium Sulfate for Post-Endoscopic Symptoms After Upper Gastrointestinal Endoscopy With Biopsy

This randomized placebo-controlled clinical trial evaluated whether intravenous magnesium sulfate reduces esophageal symptoms after upper gastrointestinal endoscopy (UGIE) with biopsy in adult patients. Participants were randomly assigned in a 1:1 ratio to receive either intravenous magnesium sulfate or 0.9% sodium chloride placebo. Post-endoscopic esophageal symptoms were assessed using the Modified Esophageal Symptoms Questionnaire (M-ESQ) at 1, 4, 24, and 48 hours after the procedure. Serum interleukin-6 (IL-6) and total calcium concentrations were measured before the procedure and 1 hour after the procedure to evaluate inflammatory and pharmacodynamic responses to magnesium sulfate.

The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety

This research will be conducted as a pre-test-post-test parallel group randomized controlled experimental study to determine the effects of two different types of hourglasses (liquid gel-based hourglass and sand-based hourglass) used for distraction during blood collection in children aged 5-10 years on pain, fear, and anxiety and the comparative effectiveness of these methods. Research Hypotheses H1: The mean pain, fear, and anxiety scores of children who used a liquid gel-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H2: The mean pain, fear, and anxiety scores of children who used a sand-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H3: The use of a liquid gel-based hourglass and a sand-based hourglass during blood collection had different effects on the mean pain, fear, and anxiety scores of children.

Buzzy® and Cognitive Behavioral Intervention Package During Blood Draw in Children

This study evaluated the effects of Buzzy® and a Cognitive Behavioral Intervention Package on pain and fear/anxiety during blood draw in children aged 7-12 years. Blood draw is a common procedure in children, but it may cause pain, fear, and anxiety. Non-pharmacological methods may help children cope better with this procedure. Children were randomly assigned to one of three groups: a control group, a Cognitive Behavioral Intervention Package group, or a Buzzy® group. Children in the control group received routine blood draw care. Children in the Cognitive Behavioral Intervention Package group received preparation, age-appropriate information, distraction, supportive guidance, parent support, and positive reinforcement. Children in the Buzzy® group received cold and vibration application before and during the blood draw procedure. Pain and fear/anxiety levels were assessed by child self-report before and immediately after the blood draw. The study aimed to determine whether Buzzy® and the Cognitive Behavioral Intervention Package reduce pain and fear/anxiety compared with routine care.

VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).

Cartoon Watching Versus Ball Squeezing During Venous Blood Sampling in Children

This single-center, parallel-group, randomized experimental study will compare the effects of two non-pharmacological distraction/coping interventions - cartoon watching and ball squeezing - on procedural pain and pain-related fear during venous blood sampling in children aged 6-9 years. The study will be conducted in the Pediatric Blood Collection Unit of Mersin University Hospital. Eligible children will be randomized to either the cartoon-watching group or the ball-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after venous blood sampling. Hypotheses * H1a: There is a difference between groups in mean WB-FACES scores during the procedure. * H1b: There is a difference between groups in mean CFS scores during the procedure.

Virtual Reality Versus Game Card Distraction During Pediatric Wound Care

This completed randomized study compared two distraction approaches with standard care during pediatric open wound care. Ninety children aged 5-10 years were assigned to standard care alone, standard care plus distraction game cards, or standard care plus immersive audiovisual virtual reality. Fear, state anxiety, pain, heart rate, and peripheral oxygen saturation were assessed immediately before and shortly after wound care. The purpose was to compare psychological and physiological responses among the three groups and to assess whether virtual reality provided additional benefit compared with game cards.

Three Distraction Techniques for Pain and Anxiety in Children During Allergy Skin Prick Testing

This randomized controlled trial compared three distraction techniques-animated cartoons, DistrACTION® Cards, and interactive video games-with standard care for reducing procedural pain and anxiety in children aged 6-10 years undergoing allergy skin prick testing. A total of 161 children were randomly assigned to four groups. Pain was rated by the child, a parent, and the researcher with the Wong-Baker FACES Pain Rating Scale during and after the procedure, and anxiety was rated by the parent and the researcher with the Children's Fear Scale before, during, and after the procedure.

VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.

Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures

This is a single-site randomized controlled pilot study at Mount Sinai Hospital evaluating the effect of virtual reality on procedural pain and anxiety in obstetric patients undergoing ultrasound-guided needle procedures. Patients will be randomized to receive either VR or standard care during the procedure and complete validated questionnaires assessing pain, anxiety, intervention acceptability, and satisfaction.

Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol

The Trauma-Informed Procedural Pain Intervention (TIPPI-R) has been developed as a standardized way to provide education and teach evidence-based strategies for managing pain and distress that may occur during pediatric cancer treatment. The purpose of this clinical trial study is to test how helpful TIPPI-R is in supporting children and families manage pain and distress during the initial stages of cancer treatment. The main questions this study aims to answer are: * Does TIPPI-R increase use of helpful pain coping strategies for pediatric cancer patients? * Does TIPPI-R help lower perceived pain intensity during initial stages of cancer treatment? * Does TIPPI-R increase patient and family confidence in coping with pain and distress during cancer treatment? Researchers will compare pain experiences and use of pain coping strategies for families who receive the TIPPI-R intervention and families who receive standard of care to see if TIPPI-R decrease pain and distress during the initial stages of cancer treatment. Participants will: * Complete surveys to measure pain and distress within 5 weeks of initial diagnosis (Time 1) * Either receive the TIPPI-R intervention or standard of care * Complete surveys to measure pain and distress 4 weeks after initial consent or TIPPI-R intervention delivery (Time 2)

Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants

The management of pain related to venipuncture remains insufficient in very preterm infants (VPI. The separation between the mother (father) and her(his) child can aggravate the short-term painful experience of the newborn. Accurate diagnosis and treatment of pain is necessary to preserve the well-being and brain development of VPI. A better understanding of the development of pain pathways and the cortical integration of nociceptive messages is essential to reach this goal.

Virtual Reality (VR) Audiovisual Distraction to Reduce Pain and Anxiety for Prone Pain Procedures

This study evaluates whether virtual reality (VR) audiovisual distraction can reduce pain, anxiety, and the need for pain and anxiety medications during prone pain procedures, compared to standard care alone. The trial design is a two-arm, parallel assignment, randomized controlled trial at a single site, the UC Davis Pain Medicine Clinic. Patients will be randomized in a 1:1 allocation to the intervention (commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support) vs control (standard medical care). The primary outcome will be a composite outcome analyzed using the Win Ratio method comparing opioid/sedative medication use, intra-procedural pain scores, and intra-procedural anxiety scores between groups. Approximately 230 people at UC Davis are expected to participate (Up to 20 patients for the preliminary run-in period to acclimatize research and clinical staff and 210 total for the randomized clinical trial). Each participant's involvement consists of one visit, estimated at 30 minutes.

Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination

This randomized controlled experimental study aims to evaluate the effects of cold spray and the Helfer Skin Tap technique on pain levels during intramuscular pneumococcal conjugate vaccine administration in 12-month-old infants. Vaccination is one of the most common painful procedures during infancy. Pain experienced during injections may cause distress in infants and anxiety in families. Therefore, simple, safe, non-pharmacological methods that can reduce injection-related pain are important in pediatric nursing and primary health care. The study will be conducted at Çorum Söğütlüevler Family Health Center between March 2026 and March 2027. The study population will consist of 12-month-old infants who attend the family health center for intramuscular pneumococcal conjugate vaccination. A total of 120 infants are planned to be included in the study. Participants will be assigned to one of three groups by stratified block randomization: cold spray group, Helfer Skin Tap group, or control group. Each group will include 40 infants. Infants in the control group will receive routine vaccination without any additional intervention. In the cold spray group, cold spray will be applied to the injection site before vaccination. In the Helfer Skin Tap group, the technique will be applied before and during the injection by gently tapping near the injection site in coordination with needle insertion. Data will be collected using a Child Information Form, an Application Record Form, and the Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC). Pain responses will be evaluated before, during, and after vaccination. Crying duration and physiological parameters such as pulse, oxygen saturation, and body temperature will also be recorded. The findings of this study are expected to contribute to evidence-based pediatric nursing practices by identifying whether cold spray or the Helfer Skin Tap technique is effective in reducing pain during infant vaccination.

Effects of Robotic Pet and Video-Based Distraction on Pain, Fear, and Anxiety in Children During Venipuncture

The goal of this randomized controlled clinical trial is to evaluate the effects of robotic pet and video-based distraction on pain, fear, and anxiety in children aged 5-10 years undergoing venipuncture. The main questions it aims to answer are: * Does robotic pet distraction reduce pain, fear, and anxiety in children during venipuncture? * Does video-based distraction reduce pain, fear, and anxiety in children during venipuncture? * Are there differences in pain, fear, and anxiety among children receiving robotic pet distraction, video-based distraction, and routine care? Children who met the eligibility criteria were randomly assigned to one of three groups the robotic pet group, video-based distraction group, or control group using simple randomization. The randomization sequence was computer-generated using RANDOM.ORG and prepared by an independent statistician. The uploaded randomization record confirms that a random sequence of participant numbers from 1 to 81 was generated. Allocation concealment was maintained using sequentially numbered, sealed, opaque envelopes, which were opened after each participant was enrolled in the study. Participants: Robotic pet group: interacted with a robotic pet as a distraction intervention during venipuncture. Video-based distraction group: watched an animal video as a distraction intervention during venipuncture. Control group: received routine care during venipuncture without an additional distraction intervention. Researchers compared the three groups to determine the effects of robotic pet and video-based distraction on children's pain, fear, and anxiety during venipuncture.