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Clinical Study on the Therapeutic Effect of MR-Based Cognitive-Distraction-Concentration-Relaxation Therapy on Perinatal Pain: A Single-Center, Randomized Controlled, Single-Blind Clinical Trial

Clinical Study on the Therapeutic Effect of MR-Based Cognitive-Distraction-Concentration-Relaxation Therapy on Perinatal Pain: A Single-Center, Randomized Controlled, Single-Blind Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116119
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

perinatal pain

Interventions

MR group:Receive MR-based treatment
Sham MR group:Receive sham MR-based treatment (2D natural content provided in MR mixed reality devices)

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
22 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant or postpartum women aged 22–40 years; 2. Willing to comply with all study-related requirements; 3. Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cognitive impairment; 2. Current or previous diagnosis of epilepsy, dementia, migraine, or any other neurological condition that could interfere with mixed-reality use or pose adverse effects; 3. Presence of nausea or dizziness; 4. Sensitivity to luminous screens; 5. Absence of stereoscopic vision or severe hearing impairment; 6. Injury to the eyes, face, or neck that would prevent comfortable wear of the headset; 7. GAD-7 score = 10 or PHQ-9 score = 10; 8. Prior use of VR or MR devices for pain management; 9. Participation in any other clinical study within the past 2 months; 10. Current employment, or having a first-degree relative employed, by a digital-health or pharmaceutical company that provides acute or chronic pain therapies.

Design outcomes

Primary

MeasureTime frame
Change in pain intensity before and after MR therapy (VAS);

Secondary

MeasureTime frame
Emotional changes before and after MR therapy ;

Countries

China

Contacts

Public Contactzhaoxuan

Shanghai Tenth People's Hospital

zhaoxuan1026@hotmail.com+86 130 5208 2279

Outcome results

None listed

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