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Study on the Effects and Mechanisms of "Zhi-shen Tiao-xing" Multisensory Care on Insomnia Patients with Deficiency of Heart and Spleen during the Stroke Recovery Phase

Study on the Effects of "Zhi-shen Tiao-xing" Multisensory Care on Insomnia Patients with Deficiency of Heart and Spleen during the Stroke Recovery Phase

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001514
Enrollment
Unknown
Registered
2026-06-17
Start date
2026-06-20
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Post-stroke Insomnia

Interventions

Control group:Routine Nursing Care for Post-stroke Insomnia
Intervention group:The "Zhi-shen Tiao-xing" multisensory care protocol primarily involves the administration of zhen fu huan rou abdominal massage, along with aromatherapy
Post-stroke Non-insomnia Group:Routine Nursing Care for Stroke

Sponsors

The Third Affiliated Clinical Hospital of Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 40–75 years; 2) Insomnia patients who meet the diagnostic criteria for ischemic stroke and chronic insomnia (referred to as "bù mèi" in traditional Chinese medicine, with the TCM syndrome pattern of heart-spleen deficiency type), and non-insomnia patients who only meet the diagnostic criteria for ischemic stroke. All patients are in the recovery phase, specifically 14 days to 6 months after stroke onset; 3) First-ever stroke, with no insomnia symptoms prior to the ischemic stroke; 4) MoCA > 26 points, SAS < 50 points, SDS < 53 points; 5) Muscle strength on the affected side graded 3–4, with Brunnstrom stage IV–V; 6) No use of sedative-hypnotic medications, or having discontinued such medications for at least 2 weeks; 7) Clear consciousness, no significant intellectual impairment, adequate verbal expression ability, and capable of independently completing questionnaires and various assessment evaluations; 8) Willing to participate voluntarily in the investigation and evaluation of this study, and having signed informed consent forms prior to the investigation; 9) Not participating in other clinical studies.

Exclusion criteria

Exclusion criteria: 1.Individuals unable to express themselves due to severe disturbances of consciousness, dementia, aphasia, deafness, or agnosia. 2.Patients with sleep disorders related to respiration, circadian rhythm sleep disorders, or parasomnias. 3.Patients with insomnia caused by systemic diseases such as pain, fever, or cough. 4.Patients with severe primary diseases involving the cardiovascular, pulmonary, hepatic, renal, or hematopoietic systems. 5.Patients with psychiatric disorders. 6.Patients with progressive malignant tumors or other severe consumptive diseases that are prone to co-infection and bleeding. 7.Those who do not meet the inclusion criteria, have poor compliance, or fail to receive treatment as prescribed. 8.Individuals unwilling to accept this clinical trial protocol. 9.Patients with insomnia caused by substance abuse or medication.

Design outcomes

Primary

MeasureTime frame
Polysomnography;Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Fatigue level;Activities of Daily Living;Traditional Chinese Medicine (TCM) Syndrome Score for Insomnia of the Heart-Spleen Deficiency TypeTraditional Chinese Medicine (TCM) Syndrome Score Scale;

Countries

China

Contacts

Public ContactSun Xuefeng

Changchun University of Chinese Medicine

2444567486@qq.com13754915157

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026