The effect and psychological mechanism of mindfulness-based intervention for insomnia on prenatal insomnia symptoms

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052269

Enrollment

Unknown

Registered

2021-10-24

Start date

2021-10-10

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

prenatal insomnia symptoms

Interventions

Intervention group:mindfulness-based intervention for insomnia

Control group:routine care and health consultation

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Singleton pregnancy; 3. 12-20 weeks of pregnancy; 4. Junior high school education level or above; 5. Regular obstetric examinations at the research hospital and planned delivery at the hospital; 6. Insomnia Severity Index (ISI) score >= 8; 7. Have a mobile WeChat account and be able to use WeChat mini-programs to participate in research; 8. Clear consciousness, normal expression, and able to fill in questionnaires independently; 9. Have not received non-drug treatment for insomnia (such as massage, acupuncture or psychological intervention, etc.) in the last 6 months and not on the waiting list for other interventions.

Exclusion criteria

Exclusion criteria: 1. Severe physical or mental illness before or now; 2. There are currently prescription or non-prescription drugs that affect sleep such as sleeping class; 3. Diagnosis of organic sleep disorders before pregnancy or now (such as obstructive sleep apnea syndrome, narcolepsy, restless legs syndrome, etc.); 4. Currently working on shifts or night shifts; 5. Suspected severe depressive symptoms (EPDS>=19 points); 6. Suicidal tendencies, with a score of >=2 on the 10th item of EPDS; 7. Patients with severe pregnancy complications or complications need to be hospitalized for miscarriage protection; 8. Previous experience in mindfulness meditation; 9. Refuse to participate in research.

Design outcomes

Primary

Measure	Time frame
Insomnia symptoms;	—

Secondary

Measure	Time frame
Subjective sleep parameters;Sleep quality;Fatigue;Daytime epworth;Depression;Anxiety;Pregnancy-related anxiety;	—

Countries

China

Contacts

Public ContactCao Fenglin

School of Nursing and Rehabilitation, Shandong University

caofenglin2008@126.com+86 13065093172

Outcome results

None listed

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