Laser Acupuncture Improves Constipation in Patients Hospitalized for Stroke During the COVID-19 Pandemic

NCT05002348 | Unknown

• 1 other identifier: 109185-F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

With the aging of today's population, stroke is the top three causes of disability and death among people over the age of 60 in the world. About 5.5 million people die each year from strokes in Taiwan, and Taiwan's top ten causes of death in cerebrovascular disease rank fourth in the world. Constipation is the most common complication of stroke patients and increases the risk of brain damage and re-stroke. Although the clinical use of drugs can relieve intestinal symptoms, there is also a risk of potential side effects. The systematic literature points out that the use of acupoint stimulation can improve spontaneous bowel movements and promote bowel motility, but there is no conclusion on effective acupuncture points. Therefore, the purpose of this study is to improve the constipation of patients with stroke by non-invasive and precise acupoint care. This study used a single-blind randomized control trial. The neurosurgery ward of a medical center in the north was used as the research site, and patients with ischemic stroke were used as the research objects. The experimental group received precision acupoint care, and the control group received routine care. The questionnaire was used to collect basic patient information (basic attributes, disease care and TCM constitution), and gut-related assessments. Data analysis was performed using IBM SPSS 22.0 software for descriptive statistical analysis and inferential statistical analysis, and p \<.05 was considered to have statistical significance.

Conditions

Ischemic Stroke

Keywords

Laser pointer; constipation

Outcome Measures

Primary Outcomes (1)

• Explore the effect of acupoint stimulation on constipation in stroke patients.

  Use patient assessment of constipation symptom (PAC-SYM) with a minimum score of 0 and a maximum of 48. The higher the score, the more serious the constipation; the constipation asscessment scale (CAS), the minimum is 0 and the maximum is 16, the higher the score, the more severe the constipation; The Bristol Stool Scale is divided into types 1 to 7, the first type is severe constipation, and the seventh type is severe diarrhea. The score is evaluated every day to understand the subject's constipation.

  10 days

Secondary Outcomes (2)

• Explore the effect of acupoint stimulation on bowel movement in patients with stroke.

  10 days

• Explore the effect of acupoint stimulation on the quality of life of stroke patients.

  10 days

Study Arms (2)

Acupoint Laser Group

EXPERIMENTAL

In the experimental group, the laser pen was turned on, and the acupoint stimulation was performed for about 3-5 minutes. Each acupoint was performed once a day. The patient wore goggles and observed the patient's vital signs (blood pressure, heartbeat, and blood pressure) with a physiological monitor. Oxygen), if the patient has any discomfort, the procedure will be stopped, and the patient's defecation status will be recorded/evaluated every day for up to 10 days (including Saturdays and Sundays). The post-test questionnaire will be conducted on the day of discharge, and the phone will be followed within one month after discharge. Inquire about the follow-up situation.

Device: Laser acupoint stimulation(Laser pen)

control group

NO INTERVENTION

In the control group, the laser pen does not turn on the energy. The acupoint stimulation is performed for about 3-5 minutes, and each acupoint is performed once a day. The patient wears goggles and observes the patient's vital signs (blood pressure, heartbeat, and blood pressure) with a physiological monitor. Oxygen), if the patient has any discomfort, the procedure will be stopped, and the patient's defecation status will be recorded/evaluated every day for up to 10 days (including Saturdays and Sundays). The post-test questionnaire will be conducted on the day of discharge, and the phone will be followed within one month after discharge. Inquire about the follow-up situation.

Interventions

Laser acupoint stimulation(Laser pen) DEVICE

Select 5-7 acupuncture points according to physical fitness. Each acupoint is performed once a day. The acupuncture point stimulation process takes about 3-5 minutes. The patient wears goggles and observes the patient's vital signs (blood pressure, heartbeat and blood oxygen) with a physiological monitor. , If the patient has any discomfort, the procedure will be stopped for a maximum of 10 days.

Acupoint Laser Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are twenty years old and above, diagnosed with ischemic stroke combined with constipation.
• A clear awareness and can communicate in national, Taiwanese, and Hakka languages.
• The score on the National Institutes of Health Stroke Scale (NIHSS) developed by the National Institutes of Health is ≦15.
• Patients who are willing to participate in this study and sign a consent form.

You may not qualify if:

• Patients undergoing intravenous injection of thrombolytic agent combined tissue plasminogen activator (r-TPA), arterial thrombectomy (IA thrombectomy).
• Imaging shows patients with brainstem stroke.
• Patients who have installed cardiac rhythm devices or ventricular-abdominal shunt surgery.
• Patients with abnormal coagulation function (with obvious spontaneous bleeding).
• Patients with malignant tumors.
• Patients with abnormal skin or obvious trauma at the location of acupuncture points.
• There are patients who have undergone surgery on their abdomen.

Sponsors & Collaborators

• Yueh-Lin Hsu: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei County, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Constipation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yueh-Lin Hsu

CONTACT

0936044110; sherry@femh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind random assignment: When subjects are confirmed to have constipation, they will be given random coding groups with envelope bags after seeking their consent, and they will be divided into experimental and control groups, and the patient will not be told whether they belong to the experimental or the control group. During execution, the laser pen of the control group did not turn on the energy, and the laser pen of the experimental group turned on the energy. The acupoint stimulation was performed for about 3-5 minutes, and each acupoint was performed once a day.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 12, 2021
• Study Start: December 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)