Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07045818
Eligibility Criteria:
Inclusion Criteria:
* Female, aged 18-45 years, right-handed;
* Diagnosis of recurrent pregnancy loss-defined as ≥2 consecutive spontaneous miscarriages before 28 weeks' gestation;
* Not currently pregnant, or diagnosed with missed abortion at the time of assessment;
* Completed structured psychiatric evaluation by licensed psychiatrists at each center, with diagnostic confirmation per DSM-5.
Exclusion Criteria:
* Use of psychotropic medications in the past month (e.g., SSRIs, SNRIs, TCAs, benzodiazepines, antipsychotics, mood stabilizers);
* Unstable or uncontrolled hypertension (SBP \> 180 mmHg or \< 90 mmHg);
* Major comorbid organic conditions (e.g., hyperthyroidism, atrial fibrillation, valvular heart disease, stroke, epilepsy, traumatic brain injury, chronic pulmonary disease);
* Significant sensory or communication barriers (e.g., hearing impairment, language difficulty, sensory neuropathy) that could impair task performance or stimulus perception;
* High suicide risk or severe psychiatric comorbidity (e.g., schizophrenia, bipolar disorder, psychotic disorders, substance use disorders);
* Extreme intolerance to auditory, visual, or cold stimuli, based on medical history or pre-test report;
* Any other condition judged by the research physician to interfere with participation in the multisensory emotional stimulation protocol.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07045818
Study Brief:
Protocol Section:
NCT07045818