Study on novel treatment techniques for neurogenic gastrointestinal disorders utilizing the neuroendocrine axis and artificial intelligence technology
| ISRCTN | ISRCTN11239735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11239735 |
| Secondary identifying numbers | Nil Known |
- Submission date
- 19/02/2024
- Registration date
- 05/03/2024
- Last edited
- 05/03/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Patients with neurosis may experience symptoms of stomach pain due to dysfunction of the autonomic nervous system, which can affect the digestive function of the gastrointestinal tract. Patients can take drugs that inhibit gastric acid secretion under the guidance of a doctor, such as omeprazole enteric-coated capsules and rabeprazole sodium enteric-coated tablets. They can also follow the doctor's advice to take gastric mucosal protective agents, such as sucralfate and bismuth potassium citrate. Neurosis can affect the digestive function of the gastrointestinal tract, causing food to accumulate in the stomach for a long time, leading to symptoms of bloating. Patients can take drugs that promote gastric motility under the guidance of a doctor, such as domperidone tablets and mosapride. They can also follow the doctor's advice to take drugs such as Jianwei Xiaoshi tablets and compound digestive enzyme tablets for treatment. Patients with neurosis may experience symptoms of reflex vomiting due to the regulation of the autonomic nervous system in the stomach. It is recommended that patients use drugs such as vitamin B6 and metoclopramide under the guidance of a doctor for treatment, or follow the doctor's advice to use drugs such as promethazine hydrochloride and chlorpromazine hydrochloride for treatment. In addition, patients with neurosis may also experience symptoms such as insomnia, anxiety, and palpitations. In the upcoming study, researchers will investigate the potential psychological treatment benefits of integrating physical music therapy into mental health interventions for patients with neurosis.
Who can participate?
Patients with neural digestive disease (intervention group) and patients with IBS-D (control group) aged between 16 and 88 years old
What does the study involve?
Participants will be randomly assigned to either a group receiving physical music therapy or a control group with no intervention. Those in the experimental group will receive music at the hospital and will continue listening at home while engaging in physical activities. Regular communication with the hospital will facilitate monitoring of progress. The study, set to span six months, aims to assess changes in psychological well-being using surveys. By comparing outcomes between the two groups, researchers hope to gain insights into the effectiveness of physical music therapy on mental health. Ethical considerations will ensure participant confidentiality and voluntary participation.
What are the possible benefits and risks of participating?
This study has the potential to inform future therapeutic approaches and contribute to the understanding of music's role in mental well-being. There are no obvious side effects in the treatment, and there are no uninformed operations, especially no medical behaviors not approved by the Chinese government, mainly using non-invasive physical therapy.
Where is the study run from?
Chifeng Cancer Hospital (China)
When is the study starting and how long is it expected to run for?
December 2023 to February 2028
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Qin Yi, 2116228604@qq.com
Contact information
Public, Scientific, Principal Investigator
Hongshan District, Chifeng City, Inner Mongolia Autonomous Region
Chifeng
024000
China
 ORCID ID |
0000-0002-6019-3719 |
|---|---|
| Phone | +86 13384768595 |
| 2116228604@qq.com |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital, Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Research on new treatment methods for neurogenic gastrointestinal diseases based on neuroendocrine axis and artificial intelligence technology |
| Study hypothesis | Music can regulate human emotions and alleviate neurological symptoms in the gastrointestinal tract |
| Ethics approval(s) |
Approved 09/02/2024, Ethics Committee of Chifeng Cancer Hospital (Chifeng Cancer Hospital in Hongshan District, Chifeng, 024000, China; +86 13030051220; ykmdphdsensorengineer@yksm.team), ref: 202401 |
| Condition | Preventing psychological illness in patients with neurogastroenteropathy |
| Intervention | Objective: To investigate the efficacy of physical music therapy on psychological well-being compared to a control group without intervention. Participants: Participants will be divided into two groups: the experimental group receiving physical music therapy and the control group without any intervention. The sample will consist of patients seeking therapeutic support in the Hongshan District, Chifeng City, Inner Mongolia Autonomous Region, China. Procedure: Recruitment and Screening: Patients seeking therapy will be recruited and screened for eligibility based on predetermined criteria. Group Allocation: Participants will be randomly assigned to either the experimental or control group. Experimental Group: Participants in the experimental group will undergo physical music therapy. They will receive music at the hospital and will be provided with corresponding download addresses for home listening. The therapy will involve a combination of face-to-face sessions and online communication. Participants will listen to the music according to their needs and report their progress to the hospital every week. Control Group: Participants in the control group will not receive any intervention and will continue with their usual routines. Duration: The intervention will span over six months, with preliminary positioning for more than one month to assess clinical needs and suitability. Outcome Measures: Psychological scales will be utilized to record changes in psychological well-being throughout the intervention period. Data Collection: Data on psychological scales will be collected at regular intervals from both groups to analyze the effectiveness of physical music therapy. Intervention Location: The intervention will primarily take place in the Hongshan District, Chifeng City, Inner Mongolia Autonomous Region, China. Additionally, music will be registered on Chinese music platforms with copyrights secured. Depending on the preliminary results, music will be promoted on online platforms. |
| Intervention type | Behavioural |
| Primary outcome measure | Pain and related symptoms in irritable bowel syndrome (IBS) measured using the IBS-Symptom Severity Scale (IBS-SSS) from baseline monthly up to 6 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2023 |
| Overall study end date | 19/02/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 88 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Free from genetic diseases 2. Patients with neural digestive disease, with no mental illness 3. Patients with IBS-D |
| Participant exclusion criteria | Diseases with obvious abnormalities in the auditory system |
| Recruitment start date | 03/04/2024 |
| Recruitment end date | 04/12/2027 |
Locations
Countries of recruitment
- China
Study participating centre
Chifeng
024000
China
Sponsor information
Hospital/treatment centre
Hongshan District, Chifeng City, Inner Mongolia Autonomous Region
Chifeng
024000
China
| Phone | +86 15172528734 |
|---|---|
| liliangyu@yksm.team | |
| Website | http://www.cfxydefsyy.com/Html/Departments/Main/Index_139.html |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 19/02/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (https://pan.baidu.com/disk/main#/index). Shared data types: Excel or Matlab data files When and how long data is available: Permanent What access standards will data be shared with: Scholars who have read relevant published literature Including who to share with: Readers who have read the paper What type of analysis to conduct: Quantitative analysis and machine learning analysis Mechanism sharing: Sharing machine learning code and raw data Have you obtained the consent of the participants: Yes Comment on data anonymization: Anonymous Any moral or legal restrictions: Comply with international and Chinese legal requirements Any other comments: Allow comments |
Editorial Notes
19/02/2024: Study's existence confirmed by the Ethics Committee of Chifeng Cancer Hospital.
