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The influence of traditional Chinese medicine's Five Elements music on perioperative anxiety, depression, and sleep quality in patients with thyroid cancer

Registration number：

ITMCTR2024000012

Date of Last Refreshed on：

2024-01-22

Date of Registration：

2024-01-22

Registration Status：

Prospective registration

Public title：

The influence of traditional Chinese medicine's Five Elements music on perioperative anxiety, depression, and sleep quality in patients with thyroid cancer

English Acronym：

Scientific title：

The influence of traditional Chinese medicine's Five Elements music on perioperative anxiety, depression, and sleep quality in patients with thyroid cancer

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zongqi Fei

Study leader：

Jianhua Wang

Applicant telephone：

15950575095

Study leader's telephone：

15312019168

Applicant Fax：

02585639613

Study leader's fax：

02585639613

Applicant E-mail：

njfzqjy_219@126.com

Study leader's E-mail：

311w@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

100 Hongshan Road Cross Street, Nanjing City, Jiangsu Province

Study leader's address：

100 Hongshan Road Cross Street, Nanjing City, Jiangsu Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Jiangsu Province Hospital on integration of Chinese and Western Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2023-LWKY-028-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Jiangsu Province Hospital on integration of Chinese and Western Medicine

Date of approved by ethic committee：

2024/1/18 0:00:00

Contact Name of the ethic committee：

lin Xie

Contact Address of the ethic committee：

100 Hongshan Road Cross Street, Nanjing City, Jiangsu Province

Contact phone of the ethic committee：

15312019168

Contact email of the ethic committee：

1025466568@qq.com

Primary sponsor：

Jiangsu Province Hospital on integration of Chinese and Western Medicine

Primary sponsor's address：

100 Hongshan Road Cross Street, Nanjing City, Jiangsu Province

Secondary sponsor：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution
hospital：

Jiangsu Province Hospital on integration of Chinese and Western Medicine

Address：

100 Hongshan Road Cross Street, Nanjing City, Jiangsu Province

Source(s) of funding：

self-raised

Target disease：

Thyroid cancer

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Summarize the basic theory of traditional Chinese medicine on thyroid cancer, as well as the theoretical basis of viscera, meridians and neuroanatomical basis of TCM Wuxing music, and plan to observe the clinical effect of TCM Wuxing music on patients with mild to moderate depression and anxiety of thyroid cancer through randomized controlled trials; The correlation between thyroid cancer and five chi and the correlation between gene mutation and five chi were discussed through statistical analysis of five chi distribution in patients with thyroid cancer. Using the methods of serum metabolomics and intestinal flora, the mechanism of the effect of Wuxing music was studied, and the scientific and standardized research of Wuxing music was carried out to provide a basis for its popularization and application.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Patients diagnosed with TC and planning to undergo surgery (the diagnosis and treatment criteria are guided by the NCCN Thyroid Cancer Treatment Guidelines); ② Those who meet the diagnostic criteria of Chinese medicine and Western medicine for mild to moderate depressive episode or anxiety disorder; ③Those who have typical symptoms of insomnia and meet the diagnostic criteria of TCM and Western medicine for insomnia; ④ Agree to participate in the study, sign the informed consent, and have good language communication skills; ⑤ Age 18-65 years old; ⑥Patients with clear consciousness, self-cognition and accurate expression of feelings, voluntary participation in the study after informed consent.

Exclusion criteria：

① Patients without thyroid surgery, or intraoperative pathological biopsy results are benign: ② Hearing impairment, brain metastasis, vestibular disease, musical epilepsy, sound sensitivity; ③ Those who have received major surgery such as organ transplantation; ④ Patients with other malignant tumors or other serious physical diseases requiring chemotherapy, radiotherapy and other special treatment; ⑤Patients with mental and psychological diseases in the past; ⑥ Patients who have had a major family or personal event within the last 30 days that may affect their emotional state.

Study execute time：

From 2024-02-01

To      2026-12-31

Recruiting time：

From 2024-02-01

To      2026-12-31

Interventions：

50

Group：

Five elements music group

Sample size：

Intervention：

TCM five elements music

Intervention code：

50

Group：

Blank control group

Sample size：

Intervention：

Conventional treatment

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution/hospital：

Jiangsu Province Hospital on integration of Chinese and Western Medicine

Level of the institution：

three-level

Outcomes：

Outcome：

Self-Rating Anxiety Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pittsbrugh sleep quality index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-rating depression scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hamilton Anxiety Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hamilton Depression Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

According to the random number table method, the subjects were randomly grouped by Zhu Guixiang, and the cases meeting the inclusion criteria were randomly divided into five elements music group and blank control group.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Public data Date: January 2027 Method: Shared via email

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The relevant data were collected according to the clinical CRF scale and clinical medical record system, and all the clinical data were established by Excel 2003 and entered into the database.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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