NCT05025436

Brief Summary

According to the "Survey on Colon Pouch Problems and Living Settlements" conducted by the Taiwan Cancer Foundation in 2017, 48% of office workers have constipation problems. The proportion of medical staff is high, especially in acute and severe units. The reason is high work pressure. , Life tension and other characteristics. In western medicine, enemas or stool softening drugs are often used in clinical treatment. This kind of treatment treats the symptoms but not the root cause. In addition, long-term use can easily cause damage to the intestinal nerves and become dependent on drugs. Systematic literature points out that the use of acupoint stimulation can effectively increase spontaneous defecation and promote bowel movements, but there is no conclusion on the effective acupuncture points. Therefore, the purpose of this research is to use precise acupoint stimulation to improve the constipation problem of nursing staff in emergency and intensive care units. This study adopts a single-blind randomized controlled Cross-over trial. Take the emergency department of a medical center in the north as the research site, and take the nursing staff of the emergency and intensive care unit with constipation as the research object. The experimental group received precise acupoint care, and the control group received routine care. After a 2-week pause, the two groups crossed. Use questionnaires to collect basic patient data (basic attributes and Chinese medical physique, etc.), and assess the intestinal tract. Data analysis uses IBM SPSS 22.0 software for descriptive statistical analysis and inferential statistical analysis, and p\<0.05 is regarded as statistically significant.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

July 28, 2021

Last Update Submit

August 25, 2021

Conditions

Keywords

Laser pointerconstipation

Outcome Measures

Primary Outcomes (3)

  • To explore the effect of acupoint stimulation on constipation of emergency and intensive nursing staff.

    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 assessment 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.

    2.5 months.

  • To explore the effect of acupoint stimulation on bowel movements of nursing staff in acute and intensive care.

    Before and after each acupoint stimulation, auscultate the subject's bowel movements to evaluate the increase in the number of bowel movements.

    2.5 months.

  • To explore the effect of acupoint stimulation on the quality of life of nursing staff in acute and intensive care.

    Use Patient Assessment of Constipation Quality of Life (PAC-QOL) to evaluate the quality of life of patients with constipation. The lowest score is 0 and the highest is 112. The higher the score, the worse the quality of life caused by constipation.

    2.5 months.

Study Arms (2)

Acupoint Laser Group

EXPERIMENTAL

Each subject in the experimental group was given the same main acupoints (5 acupoints) and physique matching acupoints (1-2 acupoints) interventional low-energy laser (Erger laser pen) acupoint stimulation, set wavelength 810nm +/- 10%, power 200mW, select Bahr parameter (B2: 1199 Hz; B3: 2398 Hz) module according to acupoints, treatment time is 30 seconds per acupoint, and the treatment dose is 3 joules per acupoint three times a week. After a period of 4 weeks, pause 2 After two weeks, the two groups crossed over and carried out 4 weeks of intervention.

Device: Acupoint stimulation with low energy laser (Erger laser pen)

Control Group

NO INTERVENTION

Each subject in the control group was given the same main acupoints (5 acupoints) and constitution matching acupoints (1-2 acupoints) without energy acupoint care (therapeutic dose is 0 joules per acupoint), three times a week, after 4 weeks After a two-week suspension, the two groups crossed over for another four-week intervention.

Interventions

Each subject was given the same main acupoints (5 acupoints) and physique matching acupoints (1-2 acupoints) interventional low-energy laser (Erger laser pen) acupoint stimulation, set wavelength 810nm +/-10%, The power is 200mW, and the Bahr parameter (B2: 1199 Hz; B3: 2398 Hz) module is selected according to the acupoints. The treatment time is 30 seconds per acupoint, and the treatment dose is 3 joules per acupoint three times a week. After a period of 4 weeks, after a 2-week pause, After the two groups crossed for 4 weeks, each subject was given the same main acupoints (5 acupoints) and physique matching acupoints (1-2 acupoints) with low-energy laser (Erjie laser pen) acupoint stimulation. Set wavelength 810nm +/-10%, power 200mW, select Bahr parameter (B2: 1199 Hz; B3: 2398 Hz) module according to acupoints, treatment time is 30 seconds per acupoint, and treatment dose is 3 joules per acupoint three times a week for a period of time 4 weeks.

Acupoint Laser Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be over twenty years old.
  • Emergency nursing staff with constipation.
  • Willing to participate in this research and sign a consent form.

You may not qualify if:

  • Nursing staff with organic disease.
  • Nursing staff with a history of gastrointestinal surgery.
  • Nursing staff with intestinal adhesions.
  • Nursing staff with a cardiac rhythm device.
  • Nursing staff with abdominal tumors.
  • Pregnant nursing staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei County, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hui-Yu Lin

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A total of 64 subjects were admitted, and they were randomly assigned into a control group and an experimental group by a crossover test, with 32 persons in each group. Random Allocation Software is used to randomly allocate 64 cases with random serial numbers generated by the computer. The 64 cases are divided into two groups with 32 people in each group. Randomly assigned serial numbers will be stored in consecutively numbered opaque sealed envelopes.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: The intervention time of the study was 2.5 months. The cross-over test was adopted. There were 2 kinds of intervention measures. Each subject in the experimental group was given the main acupoints (5 acupoints) and the physical acupoints (1-2 acupuncture points). Acupoints) Intervene in low-energy laser (Erger laser pen) acupoint stimulation, set wavelength 810nm +/-10%, power 200mW, select Bahr parameter (B2: 1199 Hz; B3: 2398 Hz) module according to the acupuncture point for treatment The time is 30 seconds per acupoint, and the therapeutic dose is 3 joules per acupoint; each subject in the control group is given the same main acupoints and physical matching acupoints without energy acupoint care (therapeutic dose is 0 joules per acupoint), three times a week, for a period of 4 Weeks later, after a 2-week suspension, the two groups crossed over for another 4 weeks of intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 27, 2021

Study Start

January 4, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations