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Study on the effect of attention diversion (distraction) during blood collection on pain and anxiety in neurology patients

The Effect of Distraction During Blood Collection on Pain and Emotional Responses in Neurological Patients: A Randomized Controlled Trial - Distraction Effects on Emotional Responses and Pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060868
Enrollment
45
Registered
2026-03-10
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Disorders

Interventions

Intervention group: The nurse facilitates attention redirection (distraction) through casual conversation. The nurse delivers the following standardized verbal prompts at each phase. Application of
I am going to apply a tourniquet to help visualize your vein. Please make a fist with your thumb tucked in.&quot
Disinfection and selection of the puncture site: &quot
Did you sleep well last night? / Is there anything you are having trouble with during your hospital stay?&quot
During needle insertion and blood collection: &quot
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 abo
Needle removal and hemostasis: &quot
re finished. Thank you for your cooperation. Please wait a moment until the bleeding stops.&quot
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 standardi
We will collect blood from this site. / I&#39
m going to disinfect the area where the needle will be inserted, so it may feel cold.&quot
I am going to insert the needle now, so it may be painful. If you feel strong pain or a tingling

Sponsors

Kawasaki City College of Nursing
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (VAS) Score for Pain : Administered within 3 minutes immediately following venipuncture.

Secondary

MeasureTime frame
Visual Analogue Scale (VAS) for Pleasantness/Unpleasantness : Administered within 3 minutes immediately following venipuncture. Visual Analogue Scale (VAS) for Satisfaction with Venipuncture : Administered within 3 minutes immediately following venipuncture. State-Trait Anxiety Inventory (STAI) (New Japanese Edition, Form JYZ) : Administered between enrollment and prior to venipuncture. Profile of Mood States, 2nd Edition (POMS 2): Japanese Adult Short Form : Administered immediately before and within 10 minutes following venipuncture.

Countries

Japan

Contacts

Public ContactTakafumi Okayama

Kawasaki City College of Nursing Graduate School of Nursing

MN2025101pk@kawasaki-cn.ac.jp044-587-3500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026