ISRCTN ISRCTN95518107
DOI https://doi.org/10.1186/ISRCTN95518107
Secondary identifying numbers PL-202408015-M
Submission date
11/09/2025
Registration date
12/09/2025
Last edited
12/09/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study objectives
Nurses often work in high-stress environments, which may lead to poor sleep and mental health problems. This study aims to evaluate whether aromatherapy combined with chakra balancing can reduce stress, improve sleep quality, and support mental well-being in nurses.

Who can participate?
Registered nurses working in hospital settings who volunteer to join and meet the inclusion criteria can participate.

What does the study involve?
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive chakra-based aromatherapy sessions five times per week for 4 weeks. The control group will continue with routine care and will not receive aromatherapy intervention. Questionnaires and physiological measurements will be collected at the start and after 4 weeks.

What are the possible benefits and risks of participating?
The possible benefits include reduced stress, improved sleep, and better emotional well-being. The risks are minimal and may include mild skin sensitivity to essential oils or temporary discomfort from questionnaires.

Where is the study taking place?
Fu Jen Catholic University Hospital (Taiwan)

When is the study starting and how long will it last?
April 2024 to December 2024

Who is funding the study?
Fu Jen Catholic University Hospital (Taiwan) (Project No. PL-202408015)

Who is the main contact?
1. Hui-Ting Chung, ting9452@yahoo.com.tw
2. Zhi-Feng Hong, skin@mail.fju.edu.tw

Contact information

Mrs Hui Ting Chung
Public, Principal Investigator

No. 69, Guizi Road
Taishan Dist.
New Taipei City
24352
Taiwan

ORCiD logoORCID ID 0009-0004-0942-371X
Phone +886 (0)917625616
Email ting9452@yahoo.com.tw
Dr Chi-Feng Hung
Scientific

510 Zhongzheng Road
Xinzhuang Dist
New Taipei City
242062
Taiwan

ORCiD logoORCID ID 0000-0003-3478-5451
Phone +886 (0)970555820
Email skin@mail.fju.edu.tw

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific titleChakra-based aromatherapy reduces stress and improves sleep in nurses: a randomized controlled trial
Study objectivesIs chakra-based aromatherapy less invasive than non-invasive? Can it reduce stress and improve sleep quality in caregivers?
Ethics approval(s)

Approved 12/07/2024, Institutional Review Board of the Fu Jen Catholic University Hospital (No. 510, Zhongzheng Road, Xinzhuang Dist, New Taipei City, 242062, Taiwan; +886 (0) (02)29056234; IRB@mail.fjuh.fju.edu.tw), ref: FJUH113388

Health condition(s) or problem(s) studiedQuality of life of nursing staff
InterventionAfter participants signed the consent form, random numbers were drawn based on gender, with odd-numbered participants assigned to the experimental group and even-numbered participants assigned to the control group (41 participants each). The random sequence was generated and maintained by an assistant not involved in recruitment and intervention to ensure that allocation was concealed and minimize bias.

82 nurses were randomly divided into an experimental group and a control group, with 41 people in each group. The treatment lasted 30 minutes five times a week for four consecutive weeks.

Chakra-based aromatherapy:
Participants will receive chakra-based aromatherapy using essential oils applied with inhalation and massage, 30 minutes per session, 5 times per week, for 4 weeks.

Routine care:
Participants will continue with routine care and will not receive aromatherapy intervention. The control group was given a placebo.
Intervention typeOther
Primary outcome measureSleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) at baseline and 4 weeks
Secondary outcome measures1. Psychological status measured by the Depression Anxiety Stress Scales-21 (DASS-21) at baseline and 4 weeks
2. Stress index measured by Heart Rate Variability (HRV) analysis at baseline and 4 weeks
3. Chakra balance measured by the Chakra Psychological Assessment Test at baseline and 4 weeks
4. Autonomic nervous system activity measured by HRV parameters: Total Power (TP), High Frequency (HF), Low Frequency (LF), Root Mean Square of Successive Differences (RMSSD) at baseline and 4 weeks
Overall study start date01/04/2024
Completion date31/12/2024

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit20 Years
Upper age limit65 Years
SexBoth
Target number of participants82 (experimental group: 41 ; control group: 41)
Total final enrolment81
Key inclusion criteria1. Registered nurses working in hospital settings
2.Willing to participate and provide written informed consent
Key exclusion criteria1. Atopic dermatitis
2. Respiratory disease
3. Pregnancy or lactation
Date of first enrolment06/08/2024
Date of final enrolment01/10/2024

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Fu Jen Catholic University Hospital
No.69, Guizi Road
Taishan Dist.
New Taipei City
24352
Taiwan

Sponsor information

Funders

Funder type

Hospital/treatment centre

Fu Jen Catholic University Hospital
Private sector organisation / Other non-profit organizations
Alternative name(s)
天主教輔仁大學附設醫院, 輔仁大學附設醫院, FJCUH
Location
Taiwan

Results and Publications

Intention to publish date01/01/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planPlan to share individual participant data (IPD): The complete IPD will not be made publicly available. However, de-identified data may be shared upon reasonable request from qualified researchers.

Time frame: Data will be available from 6 months to 3 years after publication of the main results.

Data to be shared: De-identified individual-level questionnaire results (stress, mental health, sleep quality) and physiological indicators (HRV parameters).

Additional documents: Study protocol, informed consent form (template), and statistical analysis plan will be available.

Access criteria: Researchers interested in accessing the data should submit a formal request to the corresponding author. Data will be shared after review and upon signing a Data Use Agreement (DUA).

Editorial Notes

12/09/2025: Study's existence confirmed by the Institutional Review Board of the Fu Jen Catholic University Hospital.