Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059312) titled 'Does aromatherapy during neuraxial labor analgesia enhance relaxation? An evaluation using the Analgesia/Nociception Index (ANI)' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Kitasato Univiersity
Condition:
Condition - Pregnancy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the degree of parasympathetic activity (measured by ANI) under two conditions during neuraxial labor analgesia: (1) adequate analgesia alone and (2) adequate analgesia combined with aromatherapy (inhalation).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Aromatherapy
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - Parturients at Kitasato University Hospital who are scheduled for induction of labor with neuraxial analgesia, are at > = 37 weeks gestation, have ASA Physical Status II, and provide written informed consent.
Key exclusion criteria - Exclusion Criteria
1.Parturients in whom neuraxial analgesia is not feasible
2.Parturients unable to communicate effectively
3.Parturients on chronic medication (excluding vitamins or other supplements)
4.Parturients with a psychiatric disorder requiring treatment
5.Parturients with pre-existing ECG abnormalities
6.Parturients with hypertensive disorders of pregnancy
Target Size - 16
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 18 Day
Date of IRB - 2025 Year 10 Month 07 Day
Anticipated trial start date - 2025 Year 10 Month 08 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=R000067730
Disclaimer: Curated by HT Syndication.
