Application of Douyin in Perioperative Period of Malignant Tumor Patients

NCT ID: NCT05598229

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-28
• Study Completion Date: 2025-12-30

Brief Summary

Fitting into the group of 90 cases of this study was to henan tumor hospital bone prosthesis replacement of surgical treatment of bone malignant tumors patients, evaluate watch trill to be bone prosthesis replacement surgery treatment of malignant bone tumor patients perioperative anxiety, depression, pain, explore watch trill to bone prosthesis replacement surgery treatment of malignant bone tumor patients of postoperative complications.

Detailed Description

Fitting into the group of 90 cases of this study was to henan tumor hospital bone prosthesis replacement of surgical treatment of bone malignant tumors patients, evaluate watch trill to be bone prosthesis replacement surgery treatment of malignant bone tumor patients perioperative anxiety, depression, pain, explore watch trill to bone prosthesis replacement surgery treatment of malignant bone tumor patients of postoperative complications. Eligible subjects were screened and treated with the following treatment regimen: Experimental group: Enrolled patients were encouraged to watch Douyin without limit from 24 hours before surgery to 30 minutes before surgery. He was encouraged to watch Douyin without limit until the seventh day after surgery. Control group: Viewing Douyin was forbidden from 24 hours before enrollment to the seventh day after operation. The Hospital Anxiety and Depression Self-rating Scale (HADS) and Visual analogue Scale (VAS) were used to detect the anxiety and depression of the subjects. 2. Anxiety and depression values 30 minutes before surgery; 3. Anxiety value, depression value and pain value 24 hours after operation. 4. Anxiety value, depression value and pain value at 48 hours after operation. Incidences of surgery-related complications were observed at 1 month after operation.

Conditions

Malignant Tumor of Bone; Perioperative Period

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Watch the Tik Tok

Encouraged to watch the Tik Tok.

Group Type: EXPERIMENTAL

Tik Tok

Intervention Type: OTHER

Encourage and do not restrict watching Tik Tok

Tik Tok is not allowed

Tik Tok is not allowed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tik Tok

Encourage and do not restrict watching Tik Tok

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Men and women aged 10-70. The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. Subjects with amputation can be relaxed up to 2 points.

Exclusion Criteria

Adequate organ and bone marrow function, as defined below:

Blood routine (no blood transfusion, no G-CSF, no medication correction within 7 days before screening) :

Neutrophil count (ANC)≥1,500/mm3(1.5×109/L); Platelet count (PLT)≥100,000/mm3(100×109/L); Hemoglobin (Hb)≥9g/dL(90g/L);

Blood biochemical:

Serum creatinine (Cr)≤1.5× upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula)≥60ml/min; Total bilirubin (TBIL)≤1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤2.5×ULN, and subjects with liver metastases should ≤5×ULN;

Blood coagulation function:

International normalized ratio (INR)≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN; With my consent and signed informed consent, I am willing and able to comply with the planned visit, study treatment, laboratory tests and other test procedures.

Received the following treatment within 14 days before C1D1:

Radiotherapy, chemotherapy, immune or molecularly targeted therapy for tumors. Some other investigational drugs. Surgery for other sites and/or radiotherapy were planned during the study period (24 hours before surgery to 7 days after surgery).

Imaging diagnosis showed the presence of central nervous system tumor lesions. The presence of active heart disease in the 6 months before C1D1, including myocardial infarction, severe/unstable angina pectoris, etc. Poorly controlled arrhythmias with left ventricular ejection fraction <50% on echocardiography (including QTcF interval >450ms in men and >470ms in women).

In the judgment of the investigator, there are concomitant diseases (such as severe diabetes, neurological or psychiatric diseases) or any other conditions that seriously endanger the safety of the subjects, may confuse the results of the study, or affect the completion of the study.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Wang Jiaqiang

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wang Jiaqiang, Dr

Role: CONTACT

wjqwtj@126.com

13592413731

Other Identifiers

ZZUSC-14

Identifier Type: -

Identifier Source: org_study_id