UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

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

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

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

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

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

Institute

Kyoto Prefectural University of Medicine School of Nursing

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

01

Day

URL releasing protocol

https://kpu-m.repo.nii.ac.jp/records/2760

Publication of results

Published

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

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 related 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