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A Randomized Controlled Trial of Digital Music Combined with Cognitive Behavioral Therapy (DMCBT) for Perioperative Emotional Distress in Pediatric Patients with Neurological Diseases

A Randomized Controlled Trial of Digital Music Combined with Cognitive Behavioral Therapy (DMCBT) for Perioperative Emotional Distress in Pediatric Patients with Neurological Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124053
Enrollment
Unknown
Registered
2026-05-06
Start date
2026-05-06
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Pediatric brain disease

Interventions

Intervention group:Digital Music Combined with Cognitive Behavioral Therapy + Standard of Care
Control group:Routine care

Sponsors

Huashan hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 4-18 years old with a preliminary diagnosis of neurological disorders (such as brain tumors, cerebrovascular diseases, etc.) and requiring surgical treatment, regardless of gender; 2. The children have not undergone any other cranial surgeries or similar procedures; 3. The children have normal hearing or mild hearing loss (able to clearly hear music or instructions at normal volume); 4. The children can cooperate to complete breathing training, have no history of chest surgeries, and no severe asthma history; 5. The children and their guardians voluntarily sign the informed consent form and are willing to participate in this study; 6. The children have not used any emotional intervention measures, such as digital music intervention or psychological counseling.

Exclusion criteria

Exclusion criteria: 1. There are cases of ADHD, autism spectrum disorder, epilepsy-related mental disorders, or severe cognitive and communication impairments, which prevent the patient from cooperating in completing the intervention measures; 2. The patient is currently taking psychotropic drugs (such as antidepressants, antipsychotics, anti-anxiety drugs, etc.) or participating in other experimental treatments, which may interfere with the assessment of the intervention effect; 3. The patient's emotions or behaviors are unstable, or due to recent major life events (such as parents' divorce, major family changes, etc.), there is an emotional fluctuation, affecting the objectivity of the intervention effect; 4. There is a severe hearing impairment, preventing the patient from effectively participating in the digital music intervention; 5. The patient has a history of chest surgery, severe asthma, or is underweight and malnourished, which may affect the compliance of respiratory training and the tolerance of the intervention (applicable only to the intervention group); 6. The researchers consider that other health conditions or special circumstances may interfere with data collection and the assessment of research effects for the patient.

Design outcomes

Primary

MeasureTime frame
The post-intervention pain scores and anxiety scores (both subjective and objective) of the patient;Intraoperative compliance, postoperative compliance;

Secondary

MeasureTime frame
The early postoperative activity period;Length of hospital stay;Hospitalization satisfaction;The incidence rate of pneumonia;

Countries

China

Contacts

Public ContactTianming Qiu;Yi Qin

Huashan Hospital, Fudan University

tianming2100@126.com+86 21 5460 2750

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026