UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060868 |
|---|---|
| Receipt number | R000068631 |
| Scientific Title | The Effect of Distraction During Blood Collection on Pain and Emotional Responses in Neurological Patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/03 14:24:27 |
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Basic information
Public title
Study on the effect of attention diversion (distraction) during blood collection on pain and anxiety in neurology patients
Acronym
Distraction Effects on Emotional Responses and Pain
Scientific Title
The Effect of Distraction During Blood Collection on Pain and Emotional Responses in Neurological Patients: A Randomized Controlled Trial
Scientific Title:Acronym
Distraction Effects on Emotional Responses and Pain
Region
| Japan |
Condition
Condition
Neurological Disorders
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale (VAS) Score for Pain : Administered within 3 minutes immediately following venipuncture.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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."
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kakeda |
Organization
Kawasaki City College of Nursing
Division name
Graduate School of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ku, Kawasaki-shi, Kanagawa
TEL
044-587-3500
kakeda-t@kawasaki-cn.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Okayama |
Organization
Kawasaki City College of Nursing
Division name
Graduate School of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ku, Kawasaki-shi, Kanagawa
TEL
044-587-3500
Homepage URL
MN2025101pk@kawasaki-cn.ac.jp
Sponsor or person
Institute
Kawasaki City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Kawasaki City College of Nursing
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kinki University Faculty of Medicine Ethics Committee
Address
1-14-1 Miharadai, Minami Ward, Sakai City, Osaka Prefecture
Tel
072-288-7222
zizen@med.kindai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
近畿大学病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 08 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068631
