UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050766 |
|---|---|
| Receipt number | R000057820 |
| Scientific Title | Does music listening reduce pain and anxiety in patient undergoing outpatient cystoscopy? A randomized prospective trial |
| Date of disclosure of the study information | 2023/04/06 |
| Last modified on | 2025/07/22 15:25:48 |
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Basic information
Public title
Does music listening reduce pain and anxiety in patient undergoing outpatient cystoscopy? A randomized prospective trial
Acronym
Does music listening reduce pain and anxiety in patient undergoing outpatient cystoscopy? A randomized prospective trial
Scientific Title
Does music listening reduce pain and anxiety in patient undergoing outpatient cystoscopy? A randomized prospective trial
Scientific Title:Acronym
Does music listening reduce pain and anxiety in patient undergoing outpatient cystoscopy? A randomized prospective trial
Region
| Japan |
Condition
Condition
Patients who undergo cystoscopy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of music listening on pain and anxiety perception during outpatient cystoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of pain scale(VAS) and anxiety scale(STAI) at pre-, post-procedural point between patients listening music and those not.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
music listening during cystoscopy
Interventions/Control_2
no music listening during cystoscopy
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
Key inclusion criteria
(1)Patients who undergo diagnostic cystoscopy on outpatient basis.
(2)Patients who are 18 years old or older male.
(3)Patients who are competent to provide informed consent.
Key exclusion criteria
(1)Patients who are not Japanese-speaking
(2)Patients who have active anxiety disorder.
(3)Patients who have current urinary tract infection.
(4)Patients who have anatomic urinary anomalies.
(5)Patients who have allergy to lidocaine.
(6)Patients who are considered as inappropriate to participate in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Wanifuchi |
Organization
Kushiro red cross hospital
Division name
Department of urology
Zip code
0858512
Address
21-14, Shinei-Cho, Kushiro, Hokkaido
TEL
0154-22-7171
a06m100@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Wanifuchi |
Organization
Kushiro red cross hospital
Division name
Department of urology
Zip code
0858512
Address
21-14, Shinei-Cho, Kushiro, Hokkaido
TEL
0154-22-7171
Homepage URL
a06m100@yahoo.co.jp
Sponsor or person
Institute
Kushiro red cross hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kushiro red cross hospital
Address
21-14, Shinei-Cho, Kushiro, Hokkaido
Tel
0154-22-7171
a06m100@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
https://urologyresearchandpractice.org/en/is-there-a-role-for-music-intervention-in-reducing-anxiety
Publication of results
Published
Result
URL related to results and publications
https://urologyresearchandpractice.org/en/is-there-a-role-for-music-intervention-in-reducing-anxiety
Number of participants that the trial has enrolled
93
Results
The music group showed significantly lower pain and higher satisfaction on VAS after cystoscopy compared with the control group.
By contrast, the change of physiological parameters was comparable between the groups.
Results date posted
| 2025 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 100 male patients undergoing outpatient flexible cystoscopy from
May to November 2023 were randomly assigned to the music intervention group or
control group.
Participant flow
Between May and November 2023, a total of 100 patients were
enrolled in the study. All patients were eligible and randomly assigned
to receive either cystoscopy alone (non-music group, n = 50) or cystoscopy
plus music intervention (music group, n = 50). Of these, the
full cystoscopy procedure was completed in 94 patients, but not in 6
because of urethral stricture. One patient with incomplete data was
excluded in the study. Thus, the remaining 93 patients were included
in the final analysis
Adverse events
none
Outcome measures
State-Trait Anxiety Inventory (STAI) was used to assess the
anxiety. The primary outcome was difference in the change of STAIS level before and
after the flexible cystoscopy between the groups. The secondary outcomes were pain
and satisfaction measured by visual analogue scale (VAS). In addition, physiological
change was assessed between the groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057820
