UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059061 |
|---|---|
| Receipt number | R000067558 |
| Scientific Title | Impact of Silk Nightcap Use on Hair Manageability, Sleep Quality, and Psychological Well-being: A Crossover Randomized Comparative Study |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/14 08:27:57 |
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Basic information
Public title
Impact of Silk Nightcap Use on Hair Manageability, Sleep Quality, and Psychological Well-being: A Crossover Randomized Comparative Study
Acronym
Impact of Silk Nightcap Use on Hair Manageability, Sleep Quality, and Psychological Well-being: A Crossover Randomized Comparative Study
Scientific Title
Impact of Silk Nightcap Use on Hair Manageability, Sleep Quality, and Psychological Well-being: A Crossover Randomized Comparative Study
Scientific Title:Acronym
Impact of Silk Nightcap Use on Hair Manageability, Sleep Quality, and Psychological Well-being: A Crossover Randomized Comparative Study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of nightcap use on hair manageability and psychological well-being.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
To evaluate changes in morning hair combing ease resulting from the use of a silk nightcap using a five-point Likert scale.
Key secondary outcomes
1)The reduction in morning hair styling time (hair care time) will be evaluated using recorded data on the time required for hair setting.
2)The impact on psychological well-being will be evaluated using the WHO-5 Well-Being Index.
3)The stress-relieving effect of silk nightcap use will be evaluated using the State-Trait Anxiety Inventory (STAI), an assessment scale that measures both state and trait anxiety.
4)The stress-relieving effect of silk nightcap use will be evaluated by tracking psychological and physiological stress indicators using a smartwatch.
5)The influence of nightcap use on behavioral changes related to beauty consciousness will be evaluated using a five-point Likert scale to determine whether it contributes to the enhancement of beauty awareness.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Participants will use a silk nightcap at bedtime.
Interventions/Control_2
Control group: Participants will sleep at bedtime without using a silk nightcap.
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
| 28 | years-old | > |
Gender
Female
Key inclusion criteria
Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria
Exclusion criteria for study participation are as follows:
1) Individuals who decline to participate of their own will
2) Individuals judged to be ineligible by the principal investigator
3) Individuals who routinely use a silk nightcap
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Practical Education and Research Division
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee , Hoshi University of Pharmacy and Life Sciences
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 12 | 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 | 07 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067558
