UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049696 |
|---|---|
| Receipt number | R000056600 |
| Scientific Title | the effectiveness of acupressure combination of bergamot aromatherapy oil on anxiety, sleep quality and serotonin hormone levels in post-abortion mothers |
| Date of disclosure of the study information | 2023/08/30 |
| Last modified on | 2022/12/05 16:48:30 |
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Basic information
Public title
bergamot aromatherapy and acupressure for post abortion anxiety
Acronym
bergamot aromatherapy and acupressure for post abortion anxiety
Scientific Title
the effectiveness of acupressure combination of bergamot aromatherapy oil on anxiety, sleep quality and serotonin hormone levels in post-abortion mothers
Scientific Title:Acronym
bergamot aromatherapy and acupressure for post abortion anxiety
Region
| Asia(except Japan) |
Condition
Condition
Post abortion woman
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find out the effectiveness of the acupressure combination of bergamot aromatherapy oil in reducing anxiety levels, improving sleep quality and increasing levels of the hormone serotonin in post-abortion women?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Through this research it is hoped that it will be able to increase the knowledge and skills of health workers and can be used as an alternative reference in overcoming anxiety and sleep quality in post-abortion mothers.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acupressure action of bergamot aromatherapy oil combination
Interventions/Control_2
Health education
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
| 14 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Post-abortion mothers with anxiety and disturbed sleep quality on the first day.
2) Post-abortion mothers who have not received acupressure combination of bergamot aromatherapy after the procedure.
3) Do not consume alcoholic beverages or smoke.
5) Post-abortion mothers without congenital abnormalities
6) Post-abortion mothers who are willing
7) Mother does not like the aroma of aromatherapy oil
Key exclusion criteria
1) Mothers after abortion experience emergency complications
2) None at the time of the survey
3) Mothers who have not completed medical action
4) Unprepared mother after abortion
5) Mothers who are allergic to massage oil
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | MUSYORRAFA |
| Middle name | |
| Last name | MUSTAFA |
Organization
HEALTH POLYTECHNIC MINISTRY OF HEALTH SEMARANG
Division name
MASTER OF MIDWIFERY
Zip code
50268
Address
Jl. Tirto Agung, Pedalangan, Kec. Banyumanik, Kota Semarang, Jawa Tengah
TEL
0247460274
poltekkes-smg@poltekkes-smg.ac.id
Public contact
Name of contact person
| 1st name | MUSYORRAFA |
| Middle name | |
| Last name | MUSTAFA |
Organization
HEALTH POLYTECHNIC MINISTRY OF HEALTH SEMARANG
Division name
MASTER OF MIDWIFERY
Zip code
91511
Address
JL. JENDERAL AHMAD YANI NO. 19 MAMUJU
TEL
085237314822
Homepage URL
affah.mustafa86@gmail.com
Sponsor or person
Institute
HEALTH POLYTECHNIC MINISTRY OF HEALTH SEMARANG
Institute
Department
Personal name
Funding Source
Organization
HEALTH POLYTECHNIC MINISTRY OF HEALTH SEMARANG
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
HEALTH POLYTECHNIC MINISTRY OF HEALTH SEMARANG
Address
Jl. Tirto Agung, Pedalangan, Kec. Banyumanik, Kota Semarang, Jawa Tengah
Tel
024 - 7460274
poltekkes-smg[at]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
| 2023 | Year | 08 | Month | 30 | 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
| 2022 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056600
