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Group Biofeedback Treatment for Hyperemesis Gravidarum with Psychosomatic Symptoms: A Randomized Controlled Trial

Group Biofeedback Treatment for Hyperemesis Gravidarum with Psychosomatic Symptoms: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028754
Enrollment
Unknown
Registered
2020-01-02
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperemesis Gravidarum

Interventions

experimental group:Group Biofeedback
control group:treatment as usual
experimental group:mental health education
experimental group:treatment as usual

Sponsors

Changzhou Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. diagnosis of HG in a singleton pregnancy documented by the presence of severe vomiting (more than 3 times per day without any other obvious cause), an inability to maintain oral nutrition, weight loss of more than 3 kilograms and at least one positive ketonuria test(Gynecology, 2004); 2. at least one psychosomatic syndrome according to the evaluation of DCPR-R SSI; 3. no evidence of antenatal bleeding, no antibiotic treatment, H2 blockers or proton pump inhibitors in the preceding month; 4. no psychiatric complication condition (schizophrenia, bipolar disorder, substance dependence, personality disorder).

Exclusion criteria

Exclusion criteria: With foetal anomaly, antenatal bleeding, multiple pregnancy, women with systemic disease, hyperthyroidism, hepatic disorders, urinary tract infections or intracranial disorders, gastrointestinal diseases, and pregnant women with difficulty to understand the questions and follow the instruction.

Design outcomes

Primary

MeasureTime frame
psychosomatic syndrome;heart rate variability;severity of nausea/vomiting;quality of life;

Secondary

MeasureTime frame
hospitalization days;repeated treatment times;laboratory investigations;

Countries

China

Contacts

Public ContactXuelian Cui

Changzhou Maternity and Child Healthcare Hospital

cuixuelian2006@163.com+86 15961125185

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026