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

Research purposes:

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

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

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

Research methods:

1. Selection criteria and number of people.

1. Number of subjects accepted: 100 people in this hospital The sample number is
estimated using G*power statistical software to estimate the number of samples to
be collected. The two-tailed test, the α value is 0.05, the power is 0.8, the
effect size is 0.25, and the estimated sample number is 86 people, each group is 43
people, considering the attrition rate of 20%, so the number of people in each
group is 50, and the total number of people is 100.

2. Conditions of inclusion:

1. Patients who are twenty years old and above who are diagnosed with ischemic
stroke combined with constipation. 2. A clear awareness and can communicate in
Chinese, Taiwanese, and Hakka languages. 3. The score of the National Institutes of
Health Stroke Scale (NIHSS) developed by the National Institutes of Health is ≦15.
4. Patients who are willing to participate in this study and sign the consent form.

Note: The definition of constipation

Rome IV diagnostic criteria: must include two or more of the following:

1. >25% of bowel movements feel laborious. 2. >25% of bowel movements are dry ball
or hard stools. 3. >25% of bowel movements have incompleteness. 4. >25% of bowel
movements have anorectal obstruction (or blockage). 5. >25% of bowel movements
require manual assistance. 6. Spontaneous defecation <3 times a week.

3. Exclusion conditions:

1. Patients undergoing intravenous injection of thrombolytic agent combined tissue
plasminogen activator (r-TPA), arterial thrombectomy (IA thrombectomy). 2. Imaging
shows patients with brainstem stroke. 3. Patients who have installed cardiac rhythm
devices or ventricular-abdominal shunt surgery. 4. Patients with abnormal blood
coagulation function (with obvious spontaneous bleeding). 5. Patients with
malignant tumors. 6. Patients with abnormal skin or obvious trauma at the location
of the acupuncture point. 7. There are patients who have undergone surgery on their
abdomen.

4. Recruitment method:

1. During the morning meeting, the doctors announced the purpose of the study and
the conditions for admission to let the doctors understand. 2. The ward
meeting/morning meeting announces the research plan and acceptance conditions
for the nurses to understand. 3. Check medical records and screen suitable
cases from 11G patients.

The method of consent of the research subject: will be in the patient room 1. First let
the patient understand the purpose of the research and the process and method of
collecting data. If the patient feels uncomfortable during the research process, the
patient can withdraw and terminate the research at any time, without affecting their
original treatment and care . 2. The admission process must first obtain the written
consent of the patient and the attending physician before accepting the case.

2. Research design:

1. The method of research: the research plan is approved by the IRB of our hospital →
the subject who meets the conditions is asked for consent according to the
acceptance criteria, and the consent form is signed → basic information and
pre-test questionnaires → sub-control and experimental group acceptance Case →
post-test (before discharge) → follow-up (approximately one month after discharge).

Single-blind random assignment: When subjects are confirmed to have constipation,
they will be given an envelope bag and randomly coded into groups after seeking
their consent. They are divided into experimental and control groups, and the
patient will not be told whether they belong to the experimental or the control
group.

The method of implementation of the measures: the subject of the case will be given
a pre-test questionnaire immediately after completing the consent form of the
subject, and the personnel who have received acupoint picking training will be
provided with a separate hidden environment from Monday to Friday from Monday to
Friday, and the fixed site will be given non-invasively every day Acupuncture point
stimulation. The laser pen of the control group does not turn on the energy during
execution. The laser pen of the experimental group turns on the energy. The
acupoint stimulation is performed for about 3-5 minutes. Each acupoint is performed
once a day. The physiological monitor observes the patient's vital signs (blood
pressure, heartbeat and blood oxygen). If the patient has any discomfort, the
procedure will be stopped. The patient's defecation status will be
recorded/evaluated every day for up to 10 days (including Saturdays and Sundays),
on the day of discharge. That is, a post-test questionnaire will be conducted, and
the follow-up status will be asked by telephone within one month after discharge.

2. Subject follow-up or necessary rehabilitation plan: outpatient/telephone follow-up
after discharge, a total of one interview and follow-up within one month.

3. Treatment effect evaluation and statistical analysis methods: pre-test
questionnaires are conducted when admission is admitted, and then the patient's
defecation status, stool softener usage and bowel movements will be recorded daily.
The re-evaluation of the questionnaire before discharge is a post-test. SPSS 22.0
filed for analysis.

4. Questionnaire or other research-related materials: The questionnaire contains:
basic information questionnaire, TCM physical fitness classification criteria,
constipation patient quality of life self-rating scale, Bayesian anxiety scale,
patient constipation symptom scale, Bristol stool Classification table, visual
analogy scale for constipation symptoms, constipation assessment scale.