UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054500 |
|---|---|
| Receipt number | R000061671 |
| Scientific Title | Relationship between oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding: A quasi-experimental study |
| Date of disclosure of the study information | 2024/05/29 |
| Last modified on | 2024/05/28 18:41:36 |
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Basic information
Public title
Relationship between oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding: A quasi-experimental study
Acronym
Relationship between oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding: A quasi-experimental study
Scientific Title
Relationship between oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding: A quasi-experimental study
Scientific Title:Acronym
Relationship between oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding oral hygiene management after meals and salivary secretions for patients undergoing nasogastric tube feeding: A quasi-experimental study
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aim is to clarify the effect of oral hygiene management after meals on the salivary secretions of patients undergoing nasogastric tube feeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of oral hygiene management for patients in the study sample will be evaluated.
Oral hygiene management is an academic term that refers to actions related to oral hygiene, such as improving the oral environment by cleaning the oral cavity, for example, with a toothbrush or sponge. It is considered hygiene care and daily oral care involving full assistance from nurses. Salivary secretions should be measured before oral hygiene management, immediately after, and one and two hours after. Sterile gauze (20 cm long x 3 cm wide) will be used to measure salivary secretions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The results of oral hygiene management for patients in the study sample will be evaluated. Oral hygiene management is an academic term that refers to actions related to oral hygiene, such as improving the oral environment by cleaning the oral cavity, for example, with a toothbrush or sponge. It is considered hygiene care and daily oral care involving full assistance from nurses.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have received permission from their attending physician to be evaluated and are deemed as requiring nasogastric tube feeding
Patients undergoing intermittent injections
Key exclusion criteria
Patients who do not have permission from their attending physician to be evaluated
Patients or their families who do not consent to participate in this study
Patients with extremely poor general conditions
Patients with an obvious progression of cerebrovascular disease
Patients with strong occlusal reflexes that make it difficult to measure oral moisture levels
Patients with oral cancer, head and neck cancer, or a history of radiation therapy or surgery for oral cavity-related areas
Patients with salivary gland diseases or Sjogren syndrome that organically affect saliva secretions
Patients with severe dementia and mental illness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Yamashita |
Organization
Kagoshima University
Division name
Faculty of Medicine, School of Health Sciences
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-6757
aya-yama@health.nop.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Yamashita |
Organization
Kagoshima University
Division name
Faculty of Medicine, School of Health Sciences
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-6757
Homepage URL
aya-yama@health.nop.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima 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
Kagoshima University Hospital Clinical Research Management Center
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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
| 2024 | Year | 05 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 05 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061671
