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The administration of biofeedback in patients with preterm labour

The administration of biofeedback in patients with preterm labour - HRV biofeedback in preterm labour

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00004541
Enrollment
48
Registered
2012-11-19
Start date
2006-10-20
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

O60.0

Interventions

Group 1: 6 sessions of 30 minute HRV- biofeedback training over two weeks Group 2: 6 sessions of a 30 minute control condition (visualization of HRV without training) over two weeks

Sponsors

Klinik für Psychotherapie und Psychosomatik , Universitätsklinikum der TU Dresden
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged 18 to 45 years between gestational weeks 24 to 32 will be amitted to the study after having given oral and written informed consent. The patients should have an enhanced risk for preterm birth.

Exclusion criteria

Exclusion criteria: Treatment with tricyclic antidepressants or beta blockers within 14 days prior to start of the study; diabetis mellitus; coronary artery disease; heart failure; preeclampsia;hellp syndrome.

Design outcomes

Primary

MeasureTime frame
Root mean square of successive differences of RR intervals (RMSSD) prior and post HRV biofeedback as well as 4 weeks later (follow up) by means of pulse wave analysis

Secondary

MeasureTime frame
gestational duration, psychometric variables (State Trait Anxiety Inventory, Brief Symptom Inventory, Trier Inventory for the Assessment of Chronic Stress) prior and post and 4 weeks after termination of HRV biofeedback

Countries

Germany

Contacts

Public ContactMartin Siepmann

Klinik für Psychotherapie und Psychosomatik , Universitätsklinikum der TU Dresden

martin.siepmann@uniklinikum-dresden.de0351-4582070

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026