Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062968) titled 'A Study on the Impact of the Relationship Between Couples and Healthcare Providers During Prenatal Diagnosis Counseling on Mental Health' on Sept. 17.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - pregnancy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To develop a program that facilitates decision-making support involving partners equally in prenatal diagnosis, verify its feasibility, and assess the effects of communication regarding sensitive topics on the relationship between couples and healthcare providers, as well as on the mental health of the couples.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Providing specific information and encouraging dialogue within the family can have an impact on the health of the study participants.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Pregnant women who have had a fetal heartbeat confirmed in the uterus by a physician at a participating research institution
2) Less than 15 weeks pregnant
3) Residing in Japan
4) Able to read, write, and understand everyday Japanese without difficulty
5) Scheduled to have their next prenatal checkup at the same facility as the recruitment site
Key exclusion criteria - 1) Individuals with cognitive impairments or visual or hearing impairments
2) Individuals currently receiving outpatient treatment for a mental illness
3) Individuals who face difficulties using the Japanese language
4) Women without a partner or whose partner cannot be contacted
5) Individuals who have expressed refusal to allow their information to be used in this study
6) Individuals who do not intend to continue their pregnancy
Target Size - 125
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 04 Month 02 Day
Date of IRB - 2026 Year 02 Month 19 Day
Anticipated trial start date - 2026 Year 04 Month 24 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=R000069704
Disclaimer: Curated by HT Syndication.
