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.