Malignant Tumor of BoneNCT05598229
Application of Douyin in Perioperative Period of Malignant Tumor Patients
A study testing Tik Tok in people with Malignant Tumor of Bone and Perioperative Period, run by Henan Cancer Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Malignant Tumor of Bone, Perioperative Period
- What is being tested?
- Tik Tok
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 28 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Tik Tok
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tik TokOther
Encourage and do not restrict watching Tik Tok
| Study group | Role | What they receive |
|---|---|---|
| Watch the Tik Tok | Experimental | Encouraged to watch the Tik Tok. Receives: Other: Tik Tok |
| Tik Tok is not allowed | No intervention | Tik Tok is not allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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".
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start28 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of BoneStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Jiaqiang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598229
- Sponsor's protocol ID
- ZZUSC-14
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Observe a Multicenter, Randomized, Controlled Clinical Study on the Effect of Tiktok on Perioperative Emotions of Patients Undergoing Bone Prosthesis Replacement
- ClinicalTrials.gov ID
- NCT05598229
- Acronym / sponsor ID
- ZZUSC-14
- Conditions
- Malignant Tumor of Bone, Perioperative Period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 28 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watch the Tik Tok | Experimental | Other: Tik TokEncouraged to watch the Tik Tok. |
| Tik Tok is not allowed | No intervention | –Tik Tok is not allowed. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
- 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);
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tik TokEncourage and do not restrict watching Tik Tok | Other | Watch the Tik Tok |
Primary outcome
Visual Analogue Scale
Time frame: 48 hours before surgery
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".
Hospital Anxiety Depression Scale
Time frame: 24 hours before surgery
Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.
Hospital Anxiety Depression Scale
Time frame: 30 minutes before surgery
Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.
Hospital Anxiety Depression Scale
Time frame: 24 hours after surgery
Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.
Visual Analogue Scale
Time frame: 24 hours after surgery
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".
Hospital Anxiety Depression Scale
Time frame: 48 hours after surgery
Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.
Visual Analogue Scale
Time frame: 48 hours after surgery
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tik Tok in people with Malignant Tumor of Bone and Perioperative Period, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Jiaqiang, Dr (13592413731, wjqwtj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 48 hours before surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.