UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045446
Receipt number R000051883
Scientific Title A study on breath feedback system using lamp shade for palliative care
Date of disclosure of the study information 2021/09/13
Last modified on 2023/09/25 11:47:08

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Basic information

Public title

A study on breath feedback system using lamp shade for palliative care

Acronym

Breath feedback system using lamp shade

Scientific Title

A study on breath feedback system using lamp shade for palliative care

Scientific Title:Acronym

Breath feedback system using lamp shade

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The goal of this study is to contribute to pain and stress relief in patients receiving palliative care using an easily wearable pulse sensor and a self-made Japanese-paper lampshade. To this end, the purpose of this study is to investigate the effectiveness of the developed lampshade by conducting experiments using lampshades for healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pulse wave

Key secondary outcomes

Salivary amylase, Visual analog scale, State trait anxiety inventory


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Measurement of pulse wave when watching the lamp shade.
Up to 1 hour including preparation (waiting time).

Interventions/Control_2

Measurement of pulse wave during eye closing.
Up to 1 hour including preparation (waiting time).

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

29 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adult. Recruit and request applicants.

Key exclusion criteria

Nothing in particular.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yoshinobu
Middle name
Last name Maeda

Organization

Niigata University

Division name

Faculty of Engineering

Zip code

950-2181

Address

2-8050 Ikarashi, Nishi-ku, Niigata

TEL

025-262-6754

Email

maeda@eng.niigata-u.ac.jp


Public contact

Name of contact person

1st name Yoshinobu
Middle name
Last name Maeda

Organization

Niigata University

Division name

Faculty of Engineering

Zip code

950-2181

Address

2-8050 Ikarashi, Nishi-ku, Niigata

TEL

025-262-6754

Homepage URL


Email

maeda@eng.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Niigata University

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata-shi 951-8510, Japan

Tel

025-227-2625

Email

ethics@adm.niigata-u.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

2021 Year 09 Month 13 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

9

Results

The results interpreted from these data suggest that the lamp system developed in this study is unlikely to impose a burden on the participant, and that it may take about five minutes for the effects to become apparent.

Results date posted

2023 Year 03 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 01 Month 27 Day

Baseline Characteristics

Healthy university students (5 males, 4 females, mean age 24 years)

Participant flow

Participants in the experiment were recruited randomly from among university students.

Adverse events

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2021 Year 09 Month 01 Day

Date of IRB

2021 Year 08 Month 25 Day

Anticipated trial start date

2021 Year 09 Month 21 Day

Last follow-up date

2023 Year 02 Month 25 Day

Date of closure to data entry

2025 Year 02 Month 28 Day

Date trial data considered complete

2025 Year 03 Month 31 Day

Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 09 Month 10 Day

Last modified on

2023 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name