Application of Douyin in Perioperative Period of Malignant Tumor Patients

To Observe a Multicenter, Randomized, Controlled Clinical Study on the Effect of Tiktok on Perioperative Emotions of Patients Undergoing Bone Prosthesis Replacement

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perioperative Period; Malignant Tumor of Bone
• Intervention / Treatment: Other: Tik Tok

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Jiaqiang, Dr; Phone Number: 13592413731; Email: wjqwtj@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Pathological diagnosis of malignant tumor. Patients undergoing bone prosthesis replacement for bone tumors. All acute toxicities due to previous antitumor therapy or surgery resolved to grade 0-1 (according to NCI-CTCAE version 5.0) or to enrollment/exclusion criteria by day 1 of the first cycle (C1D1), except for toxicities such as hair loss that the investigator considered to pose no safety risk to the subject).

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Watch the Tik Tok; Encouraged to watch the Tik Tok.	Other: Tik Tok; Encourage and do not restrict watching Tik Tok
No Intervention: Tik Tok is not allowed; Tik Tok is not allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured. In clinical evaluation, "0-2" was classified as "excellent", "3-5" was classified as "good", "6-8" was classified as "fair", and > 8 was classified as "poor".	48 hours before surgery
Hospital Anxiety Depression Scale	Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.	24 hours before surgery
Hospital Anxiety Depression Scale	Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.	30 minutes before surgery
Hospital Anxiety Depression Scale	Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.	24 hours after surgery
Visual Analogue Scale	A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured. In clinical evaluation, "0-2" was classified as "excellent", "3-5" was classified as "good", "6-8" was classified as "fair", and > 8 was classified as "poor".	24 hours after surgery
Hospital Anxiety Depression Scale	Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.	48 hours after surgery
Visual Analogue Scale	A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured. In clinical evaluation, "0-2" was classified as "excellent", "3-5" was classified as "good", "6-8" was classified as "fair", and > 8 was classified as "poor".	48 hours after surgery

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms; Bone Neoplasms
• Other Study ID Numbers: ZZUSC-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No