UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057553 |
|---|---|
| Receipt number | R000065742 |
| Scientific Title | THE EFFECT OF MINDFULNESS BASED STRESS REDUCTION (MBSR) ON STRESS LEVELS, PREMENSTRUAL SYNDROME, AND SEROTONIN HORMONE IN ADOLESCENTS |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2025/04/08 15:11:02 |
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Basic information
Public title
THE EFFECT OF MINDFULNESS BASED STRESS REDUCTION (MBSR) ON STRESS LEVELS, PREMENSTRUAL SYNDROME, AND SEROTONIN HORMONE IN ADOLESCENTS
Acronym
MBSR
Scientific Title
THE EFFECT OF MINDFULNESS BASED STRESS REDUCTION (MBSR) ON STRESS LEVELS, PREMENSTRUAL SYNDROME, AND SEROTONIN HORMONE IN ADOLESCENTS
Scientific Title:Acronym
THE EFFECT OF MINDFULNESS BASED STRESS REDUCTION (MBSR) ON STRESS LEVELS, PREMENSTRUAL SYNDROME, AND SEROTONIN HORMONE IN ADOLESCENTS: MBSR
Region
| Asia(except Japan) |
Condition
Condition
PREMENSTRUAL SYNDROME
Classification by specialty
| Psychosomatic Internal Medicine | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of Mindfulness Based Stress Reduction (MBSR) consisting of 8 sessions with 2 meetings per week on stress level scores, premenstrual syndrome scores, and serotonin hormone levels in adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decreased stress levels, premenstrual syndrome, and increased serotonin hormone in adolescents experiencing premenstrual syndrome
Key secondary outcomes
Increased knowledge related to the management of premenstrual syndrome for adolescents
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness Based Stress Reduction (MBSR) consisting of 8 sessions with 2 meetings a week
Interventions/Control_2
No Treatment
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
| 17 | years-old | < |
Age-upper limit
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
A. Women who experience premenstrual syndrome for at least 3 consecutive months
B. Women aged 17-25 years who are willing to be respondents
C. Women who have never been married and have never been pregnant
Key exclusion criteria
a. Women who are menstruating
b. Women who forget their menstrual date
c. Women who have been diagnosed with gynecological diseases (eg: uterine myoma, cysts, ovarian tumors, PCOS, hysterectomy, etc.)
Target sample size
81
Research contact person
Name of lead principal investigator
| 1st name | Kharisma |
| Middle name | Dwi |
| Last name | Anggraini |
Organization
Poltekkes Kemenkes Semarang
Division name
Midwifery
Zip code
64183
Address
Kab Kediri, Jawa Timur, Indonesia
TEL
+6285707563320
kharismadwi.anggraini@gmail.com
Public contact
Name of contact person
| 1st name | Kharisma |
| Middle name | Dwi |
| Last name | Anggraini |
Organization
Poltekkes Kemenkes Semarang
Division name
Midwifery
Zip code
64183
Address
Kab Kediri, Jawa Timur, Indonesia
TEL
+6285707563320
Homepage URL
kharismadwi.anggraini@gmail.com
Sponsor or person
Institute
Poltekkes Kemenkes Semarang
Institute
Department
Personal name
Funding Source
Organization
Personal Funds
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
Komite Etik Poltekkes Kemenkes Semarang
Address
Semarang, Jawa Tengah, Indonesia
Tel
-
kepk@poltekkes-smg.ac.id
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 | 04 | 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
36
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
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 10 | 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 | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065742
