UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018409 |
|---|---|
| Receipt number | R000021207 |
| Scientific Title | Effectiveness of Warm Compresses for the Eyes as a Nursing Technique to Provide Comfort - A Pilot Study Involving Healthy Individuals - |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2023/08/08 16:30:56 |
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Basic information
Public title
Effectiveness of Warm Compresses for the Eyes as a Nursing Technique to Provide Comfort
- A Pilot Study Involving Healthy Individuals -
Acronym
Effectiveness of Warm Compresses for the Eyes as a Nursing Technique to Provide Comfort
- A Pilot Study Involving Healthy Individuals -
Scientific Title
Effectiveness of Warm Compresses for the Eyes as a Nursing Technique to Provide Comfort
- A Pilot Study Involving Healthy Individuals -
Scientific Title:Acronym
Effectiveness of Warm Compresses for the Eyes as a Nursing Technique to Provide Comfort
- A Pilot Study Involving Healthy Individuals -
Region
| Japan |
Condition
Condition
This study targets 50 medical workes (females in their twenties to sixties), who understand its objective and methods, and actively express their desire to participate in it. Those with a favorable health status in the absence of diseases requiring regular medical consultation or medications will be included. While postmenopausal females' participation is not particularly limited, premenopausal females are limited to those with a normal menstrual cycle, who are able to participate in the study within 10 days after the end of their period (hypothermic phase). Warm compresses are expected to be a widely applicable nursing technique to provide patients receiving long-term care with comfort.
Classification by specialty
| Medicine in general | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the mental and physical influences of warm compresses for the eyes, using physiological, biochemical, and psychological indices, in order to confirm their effectiveness as a nursing technique to provide comfort. Clinically used warm compresses aim to promote patients' comfort and enhance the effects of treatment. Warm compresses applied to the lower back, abdominal area, and posterior region of the neck have been shown to be useful for relaxation and pain-relief, as well as sleep induction, and are adopted in clinical nursing practice. Warm compresses for the eyes are being increasingly focused on as an effective method to treat VDT syndrome, as they have been reported to improve vision and accommodation-convergence reaction, with favorable relaxing effects. On the other hand, there have been no studies examining the effectiveness of such an approach as a nursing technique to provide comfort. Therefore, in the present study involving 50 medical workes(females in their twenties to sixties), warm compresses will be applied to their eyes for 10 minutes, and the mental and physical influences will be examined using physiological, biochemical, and psychological indices to clarify the effectiveness of this approach as a nursing technique to provide comfort. If the mental and physical influences of warm compresses for the eyes are clarified, and their effectiveness as a nursing technique to provide comfort is confirmed, they may be applicable as a useful technique to promote patients' comfort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the indexes before and after intervention.Blood pressure, pulse rate, heartbeat change analysis HF,LF/HF (LF:) diastolic as for the physiologic index for the axillary temperature, the shrinkage period blood pressure It is low frequency power and HF:high frequency power ratio), blood velocity.Three times ten minutes after the intervention measure these just after intervention before intervention.The biochemical index is Japanese edition POMS(Profile of Mood States) for saliva amylase, a psychological index.These measure twice ten minutes after the intervention before intervention.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
I leave the intervals more than one week to a person targeted for equivalence and I sit down when I use the hot compress around the eyes part and measure the case.After the measurement sitting down, and having kept rest for ten minutes, I have you fill out a writing by oneself-type question questionnaire and measure a physiologic index before the intervention, a biochemical index, a psychological index.I have you spend it you carry out the hot compress around the eyes part or sitting down and measure a physiologic index just after the end, a biochemical index.Furthermore, ten minutes later, I measure a physiologic index ten minutes after the intervention, a biochemical index, a psychological index, and I have you fill out a writing by oneself-type question questionnaire, and it is with the end.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
This study targets 50 nursing students or nurses (females in their twenties to forties), who understand its objective and methods, and actively express their desire to participate in it. Those with a favorable health status in the absence of diseases requiring regular medical consultation or medications will be included. While postmenopausal females' participation is not particularly limited, premenopausal females are limited to those with a normal menstrual cycle, who are able to participate in the study within 10 days after the end of their period (hypothermic phase).
Key exclusion criteria
Those with inflammation (abnormalities of the eye, such as eye disease, inflammation, a wound, swelling, or eczema of or around the eye), hemorrhage, or irritative symptoms due to pain, for which warm compresses are contraindicated, are not allowed to participate in the study even when meeting the inclusion criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Murota |
Organization
Kyoto Prefectural university of Medicine
Division name
School of Medicine, Department of Nursing
Zip code
602-0857
Address
410, Nakagoryocho, Kamigyo-ku Kyoto-shi, Kyoto, 602-0857, Japan
TEL
075-212-5437
murota@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Murota |
Organization
Kyoto Prefectural university of Medicine
Division name
School of Medicine, Department of Nursing
Zip code
602-0857
Address
410, Nakagoryocho, Kamigyo-ku Kyoto-shi, Kyoto, 602-0857, Japan
TEL
075-212-5437
Homepage URL
murota@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine School of Nursing
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Independent Ethics Committee
Address
465, Kajikcho, Kamigyo-ku Kyoto-shi, Kyoto, 602-8566, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2015 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://kpu-m.repo.nii.ac.jp/records/2760
Publication of results
Published
Result
URL related to results and publications
https://kpu-m.repo.nii.ac.jp/records/2760
Number of participants that the trial has enrolled
42
Results
The blood flow and axillary temperature values significantly increased and the LF / HF values and the pulse rates significantly decreased after the use of EM, HEM, or AHEM.
Results date posted
| 2023 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants in this study were 42 healthcare professionals (female, 20 - 60 years of age), who voluntarily consented to participate.
Participant flow
They participated in all three interventions with EM, HEM, and AHEM at an interval of at least 1 week between interventions.
Adverse events
Not applicable.
Outcome measures
Indicators used were low frequency to high frequency ratio, blood flow, axillary temperature, pulse rate, blood pressure, the salivary amylase activity, and the Profile of Mood States Second Edition. The POMS Total Mood Disturbance score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021207
