Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058689) titled 'Development of new intervention methods to reduce stress and improve autonomic nervous function in nurses' on Aug. 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Akita University
Condition:
Condition - Female nurses working in shifts
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim is to reduce stress among nurses working in shifts. We will clarify the current state of stress and autonomic nervous function in nurses who work in shifts, and further clarify whether heart rate variability biofeedback is effective in reducing stress and activating the parasympathetic nervous system.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - After instructing the intervention group on how to use the heart rate variability biofeedback device, the device will be loaned to them, and they will perform heart rate variability biofeedback at home for a period of four weeks.
Interventions/Control_2 - The control group did not receive heart rate variability biofeedback intervention and continued their normal lifestyles.
Eligibility:
Age-lower limit - 22
years-old
Gender - Female
Key inclusion criteria - 1. Individuals who can obtain written consent from the individual to participate in the study of their own free will.
2. Female nurses working shifts at a general hospital.
3. Individuals under the age of 40.
4. Individuals who own an iPhone or Android smartphone.
Key exclusion criteria - 1. First-year graduates
2. BMI of 30 or higher
3. Those with a history of medical or mental illness
4. Those currently undergoing treatment for a medical or mental illness
5. Pregnant women
6. Others who the principal investigator or co-investigators deem inappropriate as research subjects
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 05 Month 08 Day
Date of IRB - 2024 Year 07 Month 10 Day
Anticipated trial start date - 2025 Year 08 Month 10 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067028
Disclaimer: Curated by HT Syndication.