UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000062996
Receipt number R000072117
Scientific Title Effects of Reiki Intervention on Stress Responses in Nurses: A Mixed Methods Study Using a Randomized Crossover Trial and Qualitative Analysis of Semi-Structured Interviews
Date of disclosure of the study information 2026/09/19
Last modified on 2026/09/19 16:12:07

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Basic information

Public title

A Study of the Effects of Reiki on Stress Responses in Nurses

Acronym

Reiki Study for Nurses

Scientific Title

Effects of Reiki Intervention on Stress Responses in Nurses: A Mixed Methods Study Using a Randomized Crossover Trial and Qualitative Analysis of Semi-Structured Interviews

Scientific Title:Acronym

Reiki Intervention Study for Nurses

Region

Japan


Condition

Condition

Occupational stress

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effects of Reiki intervention on nurses psychological and physiological stress responses using a mixed methods approach with a convergent design.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mood states measured using the Profile of Mood States 2nd Edition (POMS 2).
POMS 2 will be used to assess the effects of the Reiki intervention on mood states. Measurements will be conducted four times: before and after the intervention condition and before and after the control condition.

Key secondary outcomes

1. Physiological measures: Salivary amylase activity, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be measured four times, before and after the intervention condition and before and after the control condition, to evaluate physiological responses related to stress.

2. Qualitative data: Semi structured interviews will be conducted to understand experiences after the Reiki intervention.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Period 1 Reiki intervention: Participants will wear earplugs and rest in a reclining chair with towels placed over the head and eyes shoulders and body. Hands will be lightly placed on four areas including the eyes, head, ears and temporal regions, and shoulders for 5 minutes each, for a total of 20 minutes.

Washout period: 6 weeks or longer

Period 2 Control condition: Participants will wear earplugs and rest for 20 minutes in a reclining chair under the same environmental conditions as the Reiki intervention with towels placed over the head and eyes shoulders and body.

Interventions/Control_2

Period 1 Control condition: Participants will wear earplugs and rest for 20 minutes in a reclining chair under the same environmental conditions as the Reiki intervention with towels placed over the head and eyes shoulders and body.

Washout period: 6 weeks or longer

Period 2 Reiki intervention: Participants will wear earplugs and rest in a reclining chair with towels placed over the head and eyes shoulders and body. Hands will be lightly placed on four areas including the eyes, head, ears and temporal regions, and shoulders for 5 minutes each, for a total of 20 minutes.

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Participants must meet all of the following criteria. There are no restrictions based on full time or part time employment status.

1. Hold a nursing license
2. Female
3. Work 8 hours or more during a day shift
4. Work in Kyoto Prefecture, Shiga Prefecture, Osaka Prefecture, or Hyogo Prefecture
5. Work in one of the following facilities: hospital clinic with beds clinic without beds home visit nursing station long term care health facility long term care medical facility or special nursing home for older adults

Key exclusion criteria

Have previous experience of education or training in Reiki practice or previous experience of practicing Reiki

Target sample size

38


Research contact person

Name of lead principal investigator

1st name Michiyo
Middle name
Last name Oka

Organization

Gunma University

Division name

Graduate School of Health Sciences

Zip code

371-8514

Address

3-39-22 Showa-machi, Maebashi, Gunma, Japan

TEL

027-220-8926

Email

michiyooka@gunma-u.ac.jp


Public contact

Name of contact person

1st name Yu
Middle name
Last name Morimitsu

Organization

Gunma University

Division name

Graduate School of Health Sciences

Zip code

371-8514

Address

3-39-22 Showa-machi, Maebashi, Gunma, Japan

TEL

075-366-2655

Homepage URL


Email

h252a007@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Kyoto Koka University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma University

Address

3-39-15 Showa-machi, Maebashi, Gunma, Japan

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-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

京都光華大学


Other administrative information

Date of disclosure of the study information

2026 Year 09 Month 19 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


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

Preinitiation

Date of protocol fixation

2026 Year 06 Month 03 Day

Date of IRB

2026 Year 06 Month 22 Day

Anticipated trial start date

2026 Year 11 Month 01 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2026 Year 09 Month 19 Day

Last modified on

2026 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072117