Tokyo, March 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060868) titled 'Study on the effect of attention diversion (distraction) during blood collection on pain and anxiety in neurology patients' on March 10.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Kawasaki City College of Nursing

Condition: Condition - Neurological Disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to investigate the effect of distraction induced by nurses' verbal instruction during venipuncture on pain intensity and emotional response in hospitalized neurology patients. Additionally, this study aims to clarify whether this intervention contributes to the alleviation of pain and negative emotions such as anxiety. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention group: The nurse facilitates attention redirection (distraction) through casual conversation. The nurse delivers the following standardized verbal prompts at each phase.

Application of the tourniquet: "I am going to apply a tourniquet to help visualize your vein. Please make a fist with your thumb tucked in."

Disinfection and selection of the puncture site: "Did you sleep well last night? / Is there anything you are having trouble with during your hospital stay?"

During needle insertion and blood collection: "Do you remember what you ate last night? / Were there any hospital meals that you particularly enjoyed? / Are you able to eat? / Is the seasoning to your taste? / What topics have you been talking about most recently during visits or phone calls? / Have you noticed any changes in how you are feeling physically?"

Needle removal and hemostasis: "We're finished. Thank you for your cooperation. Please wait a moment until the bleeding stops." Interventions/Control_2 - Control group: Blood collection is performed according to the standard procedure, with only routine explanations related to venipuncture. In each phase, the nurse provides only the following standardized information, and no casual conversation (distraction) is conducted.

Application of the tourniquet: "I am going to apply a tourniquet to help visualize your vein. Please make a fist with your thumb tucked in."

Disinfection and selection of the puncture site: "We will collect blood from this site. / I'm going to disinfect the area where the needle will be inserted, so it may feel cold."

During needle insertion and blood collection: "I am going to insert the needle now, so it may be painful. If you feel strong pain or a tingling sensation like an electric shock, please let me know immediately. The needle has been inserted - did you feel any pain or numbness?"

Needle removal and hemostasis: "We're finished. Thank you for your cooperation. Please wait a moment until the bleeding stops."

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Inpatients at the Department of Neurology, Kindai University Hospital, who are aged 18 years or older and are right-handed. 2. Capable of communicating in Japanese, understanding the study details, and providing written informed consent. 3. Scoring 20 points or higher on the Revised Hasegawa's Dementia Scale (HDS-R). 4. Expected hospital stay of 5 days or more. Key exclusion criteria - 1. HDS-R score < 20 2. Inability to communicate in Japanese 3. Hearing impairment that makes normal conversation difficult even with hearing aids 4. Expected length of hospital stay at enrollment < 5 days 5. Clinically confirmed hypoalgesia 6. Acute or unstable psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depressive disorder) 7. Skin abnormalities at the venipuncture site or medically inappropriate for upper-limb venipuncture (e.g., post-mastectomy, vascular shunt) 8. Failure to complete venipuncture on the first attempt 9. STAI (Form JYZ): Stage 5 on either STAI-S or STAI-T 10. Use of medications that may acutely affect pain or affective-state assessments Exclusion: opioid analgesics; regular use of antipsychotics (excluding PRN use); steroid pulse therapy or within 3 days after completion Rescheduling: NSAIDs or acetaminophen within 5 hours; benzodiazepine anxiolytics within 24 hours; PRN antipsychotics within 72 hours Target Size - 45

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 29 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068631

Disclaimer: Curated by HT Syndication.