Traditional Chinese MedicineNCT05151068
the Effect of Acupoint Application Combined With Ear Acupoint Embedding in Patients After Esophageal Cancer Surgery
A study testing traditional nursing method and Precise acupoint application combined with ear acupoint embedding nursing program in people with Traditional Chinese Medicine, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To study the effect of acupoint application combined with ear acupoint seeding on the discomfort symptoms of nasal catheter in patients after esophageal cancer surgery Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Traditional Chinese Medicine
- What is being tested?
- traditional nursing method and Precise acupoint application combined with ear acupoint embedding nursing program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for esophageal cancer; Age 50-70 years old; Undertake radical surgery for esophageal cancer, and place a tube through the nose after surgery; The patient communicates well with no cognitive impairment; Informed consent for this study, signed informed consent .
Who cannot join
- Patients undergoing mechanical ventilation after surgery; Serious complications and death after surgery; Patients with external ear diseases and skin damage; Participating in other clinical research projects.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215000
Jun Zhao, 86-0512-67972216, zhaojia0327@126.com
About this study
Official title: Study on the Effect of Acupoint Application Combined With Ear Acupoint Embedding on the Discomfort Symptoms of Nasal Catheterization in Patients After Esophageal Cancer Surgery
To study the effect of acupoint application combined with ear acupoint seeding on the discomfort symptoms of nasal catheter in patients after esophageal cancer surgery
Read the detailed description
From January to December 2021, 200 patients after esophageal cancer surgery with nasal catherterization in an affiliated hospital of Soochow will be selected as the research objects, and they will be divided into experimental group (100 cases) and control group (100 cases) by random number table method. The control group will receive routine nursing care, and the experimental group will implement a precision nursing program of acupoint application combined with ear acupoint embedding on the basis of the control group. The thirst, throat pain, comfort, sleep, and unplanned extubation rate will be compared between the two groups.
- Conditions
- Traditional Chinese Medicine
- Being tested
- traditional nursing method, Precise acupoint application combined with ear acupoint embedding nursing program
- Keywords
- acupoint application, ear acupoint embedding, esophageal cancer surgery, unplanned extubation, thirst, thore throat, comfort, sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional nursing methodBehavioural
①Preoperative education, informing patients of the importance of the tube and the adverse effects of unauthorised extubation after the operation on the recovery of the disease. ②Pipe care: The nose wing is fixed with modified "human" elastic tape, and the same side cheek bridge is fixed to keep the duct unobstructed and pour gastric juice in time. ③Oral care: routinely brush teeth and gargle with mouthwash daily. ④Skin care: Observe the condition of the nose, cheek skin and oral and nasal mucosa. Replace the tape as needed, and clean the skin before fixing. ⑤ Pain care: assess the degree of pain, follow the doctor's prescription for medication, and observe the efficacy of medication. ⑥Psychological care: pay attention to the emotional changes of patients and provide psychological support.
Precise acupoint application combined with ear acupoint embedding nursing programBehavioural
On the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding.
| Study group | Role | What they receive |
|---|---|---|
| Group A,traditional | Experimental | The control group is given conventional nursing care: ①Preoperative education, informing patients of the importance of the tube and the adverse effects of unauthorised extubation after the operation on the recovery of the disease. ②Pipe care: The nose wing is fixed with modified "human" elastic tape, and the same side cheek bridge is fixed to keep the duct unobstructed and pour gastric juice in time. ③Oral care: routinely brush teeth and gargle with mouthwash daily. ④Skin care: Observe the condition of the nose, cheek skin and oral and nasal mucosa. Replace the tape as needed, and clean the skin before fixing. ⑤ Pain care: assess the degree of pain, follow the doctor's prescription for medication, and observe the efficacy of medication. ⑥Psychological care: pay attention to the emotional changes of patients and provide psychological support.This group is planned to enroll 100 patients. Receives: Behavioral: traditional nursing method |
| Group B,Precise | Experimental | On the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding.This group is planned to enroll 100 patients. Receives: Behavioral: Precise acupoint application combined with ear acupoint embedding nursing program |
What is being measured
The primary outcome is the main question the study is designed to answer.
unplanned extubation
Unplanned extubation refers to the early withdrawal of the catheter due to various reasons before the end of the treatment. This study includes the partial or complete extubation of the patient during the catheterization period. The calculation formula: (The number of cases of unplanned extubation in the group/the number of patients in the same group during the same period) × 100%.
Measured: Through study completion,an average of 7 days.
The change of thirst
Thirst is assessed by the Visual Analogue Scale (VAS), and the higher the score, the more severe the patients' thirst .
Measured: Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
The change of throe throat
Thore throat is evaluated by NRS. The higher the score, the more severe the throat pain of the patient.
Measured: Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
The change of comfort
The comfort state is evaluated by Gnneral comfort questionnaire(GCQ). The scale includes 4 dimensions of physiology, psychology, spirit, social culture and environment, with a total of 28 items. The higher the score, the better the patient's comfort state.
Measured: Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
The change of sleep
Sleep is evaluated using Athens insomnia scale (AIS). The higher the score, the worse the quality of sleep.
Measured: Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Traditional Chinese MedicineStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Luo, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151068
- Sponsor's protocol ID
- 20210928
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang TR, Han Y, Liu B, Du MB, Xiang YH, Du XH, Li ZX, Jiao Y. [Observation of acupoint application of gel plaster on insomnia]. Zhongguo Zhen Jiu. 2021 May 12;41(5):505-9. doi: 10.13703/j.0255-2930.20200423-0005. Chinese.
PubMed 34002563Yuan J, Chen Y, Yu P, Luo F, Gao Y, Chen J, Wang P, Wang Y, Zhao Y, Lei Y. Effect of magnetic stimulation of Shenmen point on cognitive function of chronic insomnia: A randomized controlled clinical trial. Medicine (Baltimore). 2020 Dec 18;99(51):e23807. doi: 10.1097/MD.0000000000023807.
PubMed 33371157Ko YL, Lin SC, Lin PC. Effect of auricular acupressure for postpartum insomnia: an uncontrolled clinical trial. J Clin Nurs. 2016 Feb;25(3-4):332-9. doi: 10.1111/jocn.13053. Epub 2015 Nov 27.
PubMed 26612319Sun JL, Sung MS, Huang MY, Cheng GC, Lin CC. Effectiveness of acupressure for residents of long-term care facilities with insomnia: a randomized controlled trial. Int J Nurs Stud. 2010 Jul;47(7):798-805. doi: 10.1016/j.ijnurstu.2009.12.003. Epub 2010 Jan 6.
PubMed 20056221Fu HY, Chen QZ, Huang ZY, Wei CN. [Effect of auricular point pressing combined with electroacupuncture on postoperative pain and inflammatory cytokines in children with hernia]. Zhongguo Zhen Jiu. 2019 Jun 12;39(6):583-7. doi: 10.13703/j.0255-2930.2019.06.004. Chinese.
PubMed 31190492Long Q, Li Y, Li J, Wen Y, Du W, Wan C, Yue C. [Clinical observation of electroacupuncture combined with auricular point sticking therapy for anal pain of mixed hemorrhoid after external excision and internal ligation]. Zhongguo Zhen Jiu. 2018 Jun 12;38(6):580-5. doi: 10.13703/j.0255-2930.2018.06.003. Chinese.
PubMed 29971998Li L, Wang J, Li Y. [Effects of auricular plaster therapy on quality of life in uremia patients after parathyroidectomy plus autograft]. Zhongguo Zhen Jiu. 2017 Sep 12;37(9):938-43. doi: 10.13703/j.0255-2930.2017.09.007. Chinese.
PubMed 29354913Wang Z, Ma J, Ning L. [Clinical observation of dysphagia after cerebral infarction treated with awn-like needle at Tiantu(CV 22)]. Zhongguo Zhen Jiu. 2016 Oct 12;36(10):1019-1022. doi: 10.13703/j.0255-2930.2016.10.004. Chinese.
PubMed 29231518
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Acupoint Application Combined With Ear Acupoint Embedding on the Discomfort Symptoms of Nasal Catheterization in Patients After Esophageal Cancer Surgery
- ClinicalTrials.gov ID
- NCT05151068
- Acronym / sponsor ID
- 20210928
- Conditions
- Traditional Chinese Medicine
- Keywords
- acupoint application, ear acupoint embedding, esophageal cancer surgery, unplanned extubation, thirst, thore throat, comfort, sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Dec 2021 (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.
To study the effect of acupoint application combined with ear acupoint seeding on the discomfort symptoms of nasal catheter in patients after esophageal cancer surgery
Detailed description
From January to December 2021, 200 patients after esophageal cancer surgery with nasal catherterization in an affiliated hospital of Soochow will be selected as the research objects, and they will be divided into experimental group (100 cases) and control group (100 cases) by random number table method. The control group will receive routine nursing care, and the experimental group will implement a precision nursing program of acupoint application combined with ear acupoint embedding on the basis of the control group. The thirst, throat pain, comfort, sleep, and unplanned extubation rate will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A,traditional | Experimental | Behavioral: traditional nursing methodThe control group is given conventional nursing care: ①Preoperative education, informing patients of the importance of the tube and the adverse effects of unauthorised extubation after the operation on the recovery of the disease. ②Pipe care: The nose wing is fixed with modified "human" elastic tape, and the same side cheek bridge is fixed to keep the duct unobstructed and pour gastric juice in time. ③Oral care: routinely brush teeth and gargle with mouthwash daily. ④Skin care: Observe the condition of the nose, cheek skin and oral and nasal mucosa. Replace the tape as needed, and clean the skin before fixing. ⑤ Pain care: assess the degree of pain, follow the doctor's prescription for medication, and observe the efficacy of medication. ⑥Psychological care: pay attention to the emotional changes of patients and provide psychological support.This group is planned to enroll 100 patients. |
| Group B,Precise | Experimental | Behavioral: Precise acupoint application combined with ear acupoint embedding nursing programOn the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding.This group is planned to enroll 100 patients. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet the diagnostic criteria for esophageal cancer; Age 50-70 years old; Undertake radical surgery for esophageal cancer, and place a tube through the nose after surgery; The patient communicates well with no cognitive impairment; Informed consent for this study, signed informed consent .
Key exclusion criteria (1 listed)
- Patients undergoing mechanical ventilation after surgery; Serious complications and death after surgery; Patients with external ear diseases and skin damage; Participating in other clinical research projects.
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 |
|---|---|---|
| traditional nursing method①Preoperative education, informing patients of the importance of the tube and the adverse effects of unauthorised extubation after the operation on the recovery of the disease. ②Pipe care: The nose wing is fixed with modified "human" elastic tape, and the same side cheek bridge is fixed to keep the duct unobstructed and pour gastric juice in time. ③Oral care: routinely brush teeth and gargle with mouthwash daily. ④Skin care: Observe the condition of the nose, cheek skin and oral and nasal mucosa. Replace the tape as needed, and clean the skin before fixing. ⑤ Pain care: assess the degree of pain, follow the doctor's prescription for medication, and observe the efficacy of medication. ⑥Psychological care: pay attention to the emotional changes of patients and provide psychological support. | Behavioural | Group A,traditional |
| Precise acupoint application combined with ear acupoint embedding nursing programOn the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding. | Behavioural | Group B,Precise |
Primary outcome
unplanned extubation
Time frame: Through study completion,an average of 7 days.
Unplanned extubation refers to the early withdrawal of the catheter due to various reasons before the end of the treatment. This study includes the partial or complete extubation of the patient during the catheterization period. The calculation formula: (The number of cases of unplanned extubation in the group/the number of patients in the same group during the same period) × 100%.
The change of thirst
Time frame: Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Thirst is assessed by the Visual Analogue Scale (VAS), and the higher the score, the more severe the patients' thirst .
The change of throe throat
Time frame: Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Thore throat is evaluated by NRS. The higher the score, the more severe the throat pain of the patient.
The change of comfort
Time frame: Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
The comfort state is evaluated by Gnneral comfort questionnaire(GCQ). The scale includes 4 dimensions of physiology, psychology, spirit, social culture and environment, with a total of 28 items. The higher the score, the better the patient's comfort state.
The change of sleep
Time frame: Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
Sleep is evaluated using Athens insomnia scale (AIS). The higher the score, the worse the quality of sleep.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Background: PubMed 34002563Wang TR, Han Y, Liu B, Du MB, Xiang YH, Du XH, Li ZX, Jiao Y. [Observation of acupoint application of gel plaster on insomnia]. Zhongguo Zhen Jiu. 2021 May 12;41(5):505-9. doi: 10.13703/j.0255-2930.20200423-0005. Chinese.
- Background: PubMed 33371157Yuan J, Chen Y, Yu P, Luo F, Gao Y, Chen J, Wang P, Wang Y, Zhao Y, Lei Y. Effect of magnetic stimulation of Shenmen point on cognitive function of chronic insomnia: A randomized controlled clinical trial. Medicine (Baltimore). 2020 Dec 18;99(51):e23807. doi: 10.1097/MD.0000000000023807.
- Background: PubMed 26612319Ko YL, Lin SC, Lin PC. Effect of auricular acupressure for postpartum insomnia: an uncontrolled clinical trial. J Clin Nurs. 2016 Feb;25(3-4):332-9. doi: 10.1111/jocn.13053. Epub 2015 Nov 27.
- Background: PubMed 20056221Sun JL, Sung MS, Huang MY, Cheng GC, Lin CC. Effectiveness of acupressure for residents of long-term care facilities with insomnia: a randomized controlled trial. Int J Nurs Stud. 2010 Jul;47(7):798-805. doi: 10.1016/j.ijnurstu.2009.12.003. Epub 2010 Jan 6.
- Background: PubMed 31190492Fu HY, Chen QZ, Huang ZY, Wei CN. [Effect of auricular point pressing combined with electroacupuncture on postoperative pain and inflammatory cytokines in children with hernia]. Zhongguo Zhen Jiu. 2019 Jun 12;39(6):583-7. doi: 10.13703/j.0255-2930.2019.06.004. Chinese.
- Background: PubMed 29971998Long Q, Li Y, Li J, Wen Y, Du W, Wan C, Yue C. [Clinical observation of electroacupuncture combined with auricular point sticking therapy for anal pain of mixed hemorrhoid after external excision and internal ligation]. Zhongguo Zhen Jiu. 2018 Jun 12;38(6):580-5. doi: 10.13703/j.0255-2930.2018.06.003. Chinese.
- Background: PubMed 29354913Li L, Wang J, Li Y. [Effects of auricular plaster therapy on quality of life in uremia patients after parathyroidectomy plus autograft]. Zhongguo Zhen Jiu. 2017 Sep 12;37(9):938-43. doi: 10.13703/j.0255-2930.2017.09.007. Chinese.
- Background: PubMed 29231518Wang Z, Ma J, Ning L. [Clinical observation of dysphagia after cerebral infarction treated with awn-like needle at Tiantu(CV 22)]. Zhongguo Zhen Jiu. 2016 Oct 12;36(10):1019-1022. doi: 10.13703/j.0255-2930.2016.10.004. Chinese.
- 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.
Jing Luo principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional nursing method and Precise acupoint application combined with ear acupoint embedding nursing program in people with Traditional Chinese Medicine, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 1 inclusion and 1 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jun Zhao (86-0512-67972216, zhaojia0327@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
unplanned extubation (time frame: Through study completion,an average of 7 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151068, which also lists 8 linked publications.
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 9 Dec 2021.