UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045995 |
|---|---|
| Receipt number | R000052495 |
| Scientific Title | Effect of tiny beaded tape on the lower abdominal wall against menstrual pain |
| Date of disclosure of the study information | 2021/11/08 |
| Last modified on | 2023/11/14 15:47:19 |
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Basic information
Public title
Effect of tiny beaded tape on the lower abdominal wall against menstrual pain
Acronym
Effect of tiny beaded tape on the lower abdominal wall against menstrual pain
Scientific Title
Effect of tiny beaded tape on the lower abdominal wall against menstrual pain
Scientific Title:Acronym
Effect of tiny beaded tape on the lower abdominal wall against menstrual pain
Region
| Japan |
Condition
Condition
Menstrual pain
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of slight tactile stimulation on the lower abdominal wall against menstrual pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analogue scale of pain
(Assess once in the follicular phase and once in each of the two menstrual periods, respectively)
Key secondary outcomes
1. Pain degree recorded by PAIN VISION 2100 (NIPRO, Osaka)
2. SF-MPQ (Melzack, 1987; Yamaguchi, et al., 2007)
3. Face Scale (Hics, et al., 2001)
4. Behavioral assessment scale of pain (Strong, 2002)
5. Heptagon profile of pain (Sato, et al., 1990)
6. SF-POMS-J (Yokoyama, 2005)
(These key secondary outcomes will be assessed once in the follicular phase and once in each of the two menstrual periods, respectively)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1. Apply the beaded tape to the lower abdomen during menstruation
2. Do not apply anything to the lower abdomen during the subsequent menstrual period
Interventions/Control_2
1. Do not apply anything to the lower abdomen during the menstrual period
2. Apply the beaded tape to the lower abdomen during the subsequent menstrual period
Interventions/Control_3
1. Apply the non-beaded tape to the lower abdomen during menstruation
2. Do not apply anything on the lower abdomen during the subsequent menstrual period
Interventions/Control_4
1. Do not apply anything to the lower abdomen during the menstrual period
2. Apply the non-beaded tape to the lower abdomen during the subsequent menstrual period
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy nonparous women
Women with moderate menstrual pain but not treated for dysmenorrhea
Key exclusion criteria
Women who are prone to skin irritation and redness with tapes
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kiyoko |
| Middle name | |
| Last name | Fukai |
Organization
The Jikei University
Division name
School of Nursing
Zip code
182-8570
Address
8-3-1, Kokuryo-cho, Chofu-city, Tokyo, 182-8570, Japan
TEL
03-3480-1151(2741)
scully@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoko |
| Middle name | |
| Last name | Fukai |
Organization
The Jikei University
Division name
School of Nursing
Zip code
182-8570
Address
8-3-1
TEL
09094675980
Homepage URL
scully@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of The Jikei University
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111(2134)
rinri@jikei.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
| 2021 | Year | 11 | Month | 08 | 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
27
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052495
