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A study of VR digital therapy in perinatal management

Immersive virtual reality to reduce simulated labour pain in healthy adult males:a clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104471
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Obstetric anaesthesia and analgesia

Interventions

Within-subjects design:The subjects wore the Rui Le Mei labor pain experience device and sat comfortably on the sofa, with good freedom of movement for their upper body and arms. They tied a blood pre

Sponsors

Shenzhen Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-40 years old; 2. Body mass index (BMI): 18.5~34.9 kg/m^2; 3. No barrier to understanding and communication; 4.No serious health problems or psychological diseases; 5. Participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Acute pain, chronic pain; 2. Peripheral or central nervous system diseases and psychosomatic disorders; 3. Recent use of analgesic hypnotics and drugs that may cause mental abnormalities, alcohol or drug abuse; 4. Those who have serious claustrophobia, motion sickness, motion sickness and other related diseases in the past, and those who have serious discomfort with VR equipment; 5. Hearing abnormality or visual impairment, communication disorders; 6. Those with cardiovascular disease, heart disease, heart, liver and kidney insufficiency, epilepsy, hyperthyroidism, fever and other diseases that cannot tolerate stimulation; 7. Diseases such as abdominal and head and face trauma and infection; 8. Previous experience of major painful trauma.

Design outcomes

Primary

MeasureTime frame
Pain level and pain unpleasantness scores;

Secondary

MeasureTime frame
Difference between pre-intervention-post-intervention Positive and Negative Affect Schedule scores;Pre-post intervention variability in blood pressure, heart rate, respiratory rate, Oxygen saturation,perfusion index;Pain relief satisfaction scores;Attention Diversion Immersion Score;Electroencephalogram (EEG) Analysis;

Countries

China

Contacts

Public ContactLi Yuantao

Shenzhen Maternity and Child Healthcare Hospital

szmchlyt@smu.edu.cn+86 138 0227 1355

Outcome results

None listed

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