UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018409
Receipt No. 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 2019/07/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email murota@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine School of Nursing
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 42
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 No longer recruiting
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
2019 Year 06 Month 10 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
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021207

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.