UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006300 |
|---|---|
| Receipt number | R000007457 |
| Scientific Title | the effect of pleasure during hot compresses to the posterior region of the neck : a randomised controlled trial |
| Date of disclosure of the study information | 2011/09/07 |
| Last modified on | 2011/09/07 10:30:05 |
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Basic information
Public title
the effect of pleasure during hot compresses to the posterior region of the neck : a randomised controlled trial
Acronym
development of an effect model for the pleasure experienced during
application of hot compress to the posterior region of the neck
Scientific Title
the effect of pleasure during hot compresses to the posterior region of the neck : a randomised controlled trial
Scientific Title:Acronym
development of an effect model for the pleasure experienced during
application of hot compress to the posterior region of the neck
Region
| Japan |
Condition
Condition
nursing
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study was to elucidate the effects of application of a hot compress to the posterior region of the neck (PRN) in inpatients, and to develop an effect model using covariance structure analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a questionnaire on "subjective comfort" and "ease of living", skin temperature of the hands and feet, salivary amylase, and tympanic temperature were measured as "physiological indices", and diet, excretion, and sleep were investigated as part of an interview on lifestyle.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
a heat- and steam-generating sheet (intervention group) was applied to the posterior region of the neck for 10 minutes per day for three consecutive days.
Interventions/Control_2
a non-warming sheet (control group) was applied to the posterior region of the neck for 10 minutes per day for three consecutive days.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients who can understand the questionnaire.
Key exclusion criteria
1.patients with skin disease.
2.patients with inflammatory disorder.
3.patients with fortunetelling bleeding
4.women with climacteric symptoms.
5.disorientation patients.
6.patients who cannot do a conversation.
7.patients who take a beta-blocker.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kyori kato |
Organization
tokyo women's medical university
Division name
school of nursing
Zip code
Address
400-2, Shimohijikata Kakegawa-city Shizuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
tokyo women's medical university
Division name
school of nursing
Zip code
Address
TEL
Homepage URL
egami@nurs.twmu.ac.jp
Sponsor or person
Institute
tokyo women's medical university
Institute
Department
Personal name
Funding Source
Organization
Incorporated administrative agency Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 09 | Month | 07 | 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
excluding the patients who dropped out, the intervention and control groups included 27 and 25 patients,respectively.
there were no significant differences in attributes between the two groups.
the 52 subjects had a mean age of 68.7 years, and included 37 women (71%) and 44 orthopedic patients (85%).
intragroup comparison showed that palm and plantar skin temperature increased and tympanic temperature decreased in the intervention group following intervention, but no significant intergroup differences were observed.
as for questionnaire results, "pleasure during application of hot compress", "increased vitality", and "positive outlook on life" were significantly higher in the intervention group. regarding lifestyle, the intervention group had a significantly longer "subjective sleep time".
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
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 07 | Day |
Last modified on
| 2011 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007457
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
