UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059244 |
|---|---|
| Receipt number | R000067758 |
| Scientific Title | Effects of Reiki Intervention on Stress Responses in Nurses: A Randomized Crossover Trial and Qualitative Analysis Through Semi-Structured Interviews in a Mixed-Methods Study |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/10/01 11:03:36 |
* 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
A study to examine the effects of Reiki treatment on stress among nurses
Acronym
REIKI for Nurses Study
Scientific Title
Effects of Reiki Intervention on Stress Responses in Nurses: A Randomized Crossover Trial and Qualitative Analysis Through Semi-Structured Interviews in a Mixed-Methods Study
Scientific Title:Acronym
Effects of Reiki Intervention on Stress Responses in Nurses
Region
| Japan |
Condition
Condition
Stress response (Occupational stress)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of a Reiki intervention on psychological and physiological stress responses in nurses using a convergent mixed-methods approach. Quantitatively, effects will be tested with psychological scales and physiological indices; qualitatively, experiences will be analyzed from semi-structured interviews. Hypothesis: stress responses will be lower under the intervention than under the control condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Profile of Mood States, 2nd Edition - Japanese Adult Short version (POMS 2 - Japanese Adult Short version)
Key secondary outcomes
Pulse rate, respiration rate, blood pressure, salivary alpha-amylase (sAA) activity, and qualitative data from semi-structured interviews
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reiki treatment (20 minutes) provided while resting in a reclining chair immediately after the end of a work shift.
Interventions/Control_2
Resting in a reclining chair for 20 minutes immediately after the end of a work shift, without receiving an intervention.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Nurses engaged in clinical practice
2. Those working in the following facilities: hospitals, clinics (with/without beds), home-visit nursing stations, and long-term care facilities (long-term care health facilities, long-term care medical facilities, special nursing homes, etc.)
3. Nurses working during daytime shifts
Key exclusion criteria
Exclusion criteria include any of the following:
1. Received Reiki from another practitioner within the past 6 weeks, or has received Reiki training in the past
2. Experienced major life events within the past 6 months (e.g., pregnancy, childbirth, bereavement of a close relative, relocation, job change)
3. Presence of physical or mental disorders that may affect stress responses (hypertension, heart disease, diabetes, chronic respiratory disease, thyroid dysfunction, depression, bipolar disorder, PTSD) with unstable treatment within 6 months of diagnosis
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Morimitsu |
Organization
Kyoto Koka Women's University
Division name
Department of Nursing, The Faculty of Nursing, Welfare and Rehabilitation Gerontological Nursing
Zip code
615-0882
Address
38, Katsunoucho, Nishikyogoku, Ukyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-366-2655
y-morimitsu@mail.koka.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Morimitsu |
Organization
Kyoto Koka Women's University
Division name
Department of Nursing, The Faculty of Nursing, Welfare and Rehabilitation Gerontological Nursing
Zip code
615-0882
Address
38, Katsunoucho, Nishikyogoku, Ukyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-366-2655
Homepage URL
y-morimitsu@mail.koka.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Yu Morimitsu
Funding Source
Organization
None
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
Tojinkai Hospital
Address
83-1 Momoyama-cho Iga, Fushimi-ku, Kyoto, Japan
Tel
075-622-1991
075-622-1991
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
桃仁会病院（京都府）、南港病院（大阪府）、桃仁会病院 附属診療所（京都府）、桃仁会クリニック（京都府）、老人保健施設 桃寿苑（京都府）、かつら透析クリニック（京都府）、からすま透析クリニック（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | 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
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067758
