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A Study on the Effect of Cranial Rhythmic Massage on Sleep Quality in Hemodialysis Patients with Insomnia of Heart-Spleen Deficiency Type

A Study on the Effect of Cranial Rhythmic Massage on Sleep Quality in Hemodialysis Patients with Insomnia of Heart-Spleen Deficiency Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001053
Enrollment
Unknown
Registered
2026-04-24
Start date
2026-05-05
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Maintenance Hemodialysis

Interventions

Intervention group:On the basis of routine nursing for maintenance hemodialysis, head rhythm massage intervention was administered
Control group:Only routine nursing for maintenance hemodialysis was provided

Sponsors

The Affiliated Hospital of Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 45 and 74 years (inclusive). 2) Meet the diagnostic criteria for chronic insomnia, with a Traditional Chinese Medicine (TCM) pattern of insomnia classified as heart-spleen deficiency type. 3) Have undergone stable hemodialysis for more than 3 months, receiving dialysis three times per week, 4 hours per session, with adequate dialysis adequacy. 4) Have a Pittsburgh Sleep Quality Index (PSQI) score >7. 5) Have not received any sleep-related interventions (e.g., medication) within the past 2 weeks. 6) All subjects are in a stable condition without other serious complications, are conscious, have no intellectual or hearing impairments, are able to express themselves fluently, and can cooperate with all observational assessments. 7) All subjects voluntarily participate in this study and have signed the voluntary informed consent form.

Exclusion criteria

Exclusion criteria: 1)Presence of severe organic diseases of internal organs (e.g., heart or cerebrovascular diseases), tumors, or other severe consumptive conditions that predispose to infection and bleeding; 2)Insomnia caused by systemic diseases such as pain, fever, cough, surgery, or external environmental interfering factors; 3)Recent major psychological trauma or mental illness; 4)Sleep disorders related to respiration, circadian rhythm sleep disorders, or sleep dysfunction; 5)Skin infection or skin breakdown at the treatment site; 6)Patients unable to tolerate acupoint massage and music therapy.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) Score;

Secondary

MeasureTime frame
Athens Insomnia Scale (AIS) Score;Self-rating Anxiety Scale (SAS) Score;Self-rating Depression Scale (SDS) Score;

Countries

China

Contacts

Public ContactYujiao Ding

Changchun University of Chinese Medicine

dingyj2024@126.com13963991147

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026