A Preliminary Randomized Controlled Trial with Healthy Subjects to Validate Interviewing Procedures for Self-Understanding

UMIN ID: UMIN000056105

Registered date:08/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy control
• Date of first enrollment: 2024/10/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Content: Interviews featuring questions predicated on the EXP scale score of 3 or higher. Frequency: Once
Content: Interviews featuring questions based on the EXP scale score of 2 or lower. Frequency: Once

Outcome(s)

• Primary Outcome: Rate of occurrence of EXP scale during QOL interview
• Secondary Outcome: 1. Mean change in SEIQoL-DW pre- and post-interview scores. 2. Mean change in PANAS pre- and post-interview scores. 3. Mean change in CORE-OM pre- and post-interview scores.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Individuals who predominantly use a language other than their native language or Japanese in their daily activities. (2) Participants who encounter challenges when conducting semi-structured interviews. (3) Other potential subjects identified as unsuitable research participants by the principal investigator.

Related Information

• Primary Sponsor: Kansai Medical University
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology