UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031100 |
|---|---|
| Receipt number | R000035518 |
| Scientific Title | Effect of aroma massage on quality of sleep in the palliative care ward: a randomized trial |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2019/08/05 08:39:18 |
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Basic information
Public title
Effect of aroma massage on quality of sleep in
the palliative care ward: a randomized trial
Acronym
Effect of aroma massage on quality of sleep in
the palliative care ward
Scientific Title
Effect of aroma massage on quality of sleep in
the palliative care ward: a randomized trial
Scientific Title:Acronym
Effect of aroma massage on quality of sleep in
the palliative care ward
Region
| Japan |
Condition
Condition
palliative care
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effect of aroma massage on quality of sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quality of sleep evaluated by Richards Campbell Sleep Questionnaire on the day of aroma massage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
30-minute aroma massage on the limbs before bedtime
Interventions/Control_2
nontreatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are hospitalized in the palliative care ward
Subjects who have been in the ward for 3 days or more
Key exclusion criteria
Subjects who are not able to answer questionnaires
Subjects who change sleep medications on the procedure day
Subjects who had changed steroids < 7 days prior to study treatment
Subjects with any known mass, inflammation, pain and open wound on the massage regions
Prior treatment with aroma massage
Subjects with prior hypersensitivity to aroma essential oil
Subjects who are discharged within four days
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
National Hospital Organization Kyoto medical center
Division name
Palliative care
Zip code
6128555
Address
1-1 Fukakusamukaihata-cho Fushimi-ku Kyoto city, Kyoto
TEL
075-641-9161
off.kawabata@gmail.com
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Palliative care
Zip code
6128555
Address
1-1 Fukakusamukaihata-cho Fushimi-ku Kyoto city, Kyoto
TEL
075-641-9161
Homepage URL
off.kawabata@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
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
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusamukaihata-cho Fushimi-ku Kyoto city, Kyoto
Tel
075-641-9161
off.kawabata@gmail.com
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
| 2018 | Year | 02 | Month | 01 | 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
74
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
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 25 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035518
