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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05612646
Other study ID # CF20208B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 11, 2020
Est. completion date October 24, 2022

Study information

Verified date May 2023
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As a form of non-invasive auxiliary care, Traditional Chinese Medicine acupressure can prevent constipation, reduce medication for constipation, save medical costs, and alleviate constipation among inpatients in neurology departments, as well as improve patients' general ease and comfort of defecation, thereby improving their quality of life. It also provides clinical nursing staff with a more effective, safer, and more comfortable auxiliary method of preventing constipation, and can be used as a reference for the nursing of such patients.


Description:

Background: Constipation is a common problem among geriatric patients and in neurology departments. However, using stool softeners and enemas yield only temporary effects and may even lead to alternating constipation, diarrhea, and metabolic disorders. Because of its non-invasive nature, Acupressure can be used as adjuvant therapy of integrated traditional Chinese and western medicine to prevent constipation among inpatients in neurology departments. It is necessary to verify that Acupressure can be applied to avoid and alleviate patients' constipation, improve their comfort, and improve their quality of life. Objective: To explore the effect of Acupressure in alleviating constipation among inpatients in neurology departments.Method: A randomized controlled two-group pre-test and post-test experiment design were adopted in this study; neurology department inpatients were randomly assigned to either the experimental group, which comprised 64 subjects receiving Acupressure on three acupoints (Tianshu, ST25: Stomach Meridian 25; Zhongwan CV12: Conception Vessel 12; Qihai CV6: Meridian Vessel 6) or the control group which comprised 64 subjects receiving routine nursing and fake Acupressure. The research tools included the Bristol Stool Form and Constipation Assessment Scale.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date October 24, 2022
Est. primary completion date October 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age = 20 years old 2. Established diagnosis of stroke (ischemic, hemorrhagic acute phase) 3. NIHSS 1-20 points 4. Undiagnosed within three months before admission With intestinal disease and no rectal resection 5. meeting the diagnostic criteria for functional constipation (Rome IV). Exclusion Criteria: 1. Abdominal surgery or abdominal radiotherapy within three months 2. Abdominal cancer including liver, large intestine, lymph, and pelvic cavity, etc., 3. Massive ascites 4. There are implants in the abdominal cavity, such as V-P Shunt, L-P Shunt, CAPD, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Acupressure
The patients assigned to the experimental group received acupoint massage designed to improve constipation for 7 days during hospitalization. The selection of acupoints in this study includes "Tianshu (double)" (Tianshu, ST25: Stomach Meridian 25, the 25th point of the stomach meridian), "Zhongwan (single)" (Zhongwan CV12: Conception Vessel 12, the 12th point of the Ren meridian) ), "Qihai Point (Single)" (Qihai CV6: Meridian Vessel 6 Renmai 6th point) 3 points.
routine nursing and fake acupressure
control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization.

Locations

Country Name City State
Taiwan 1650 Taiwan Boulevard Sect. 4 Taichung

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Abbasi P, Mojalli M, Kianmehr M, Zamani S. Effect of acupressure on constipation in patients undergoing hemodialysis: A randomized double-blind controlled clinical trial. Avicenna J Phytomed. 2019 Jan-Feb;9(1):84-91. — View Citation

Bharucha AE, Lacy BE. Mechanisms, Evaluation, and Management of Chronic Constipation. Gastroenterology. 2020 Apr;158(5):1232-1249.e3. doi: 10.1053/j.gastro.2019.12.034. Epub 2020 Jan 13. — View Citation

Birimoglu Okuyan C, Bilgili N. Effect of abdominal massage on constipation and quality of life in older adults: A randomized controlled trial. Complement Ther Med. 2019 Dec;47:102219. doi: 10.1016/j.ctim.2019.102219. Epub 2019 Oct 16. — View Citation

Chen MC, Yang LY, Chen KM, Hsu HF. Systematic Review and Meta-Analysis on Using Acupressure to Promote the Health of Older Adults. J Appl Gerontol. 2020 Oct;39(10):1144-1152. doi: 10.1177/0733464819870027. Epub 2019 Aug 19. — View Citation

Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Ep — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The constipation assessment scale scores Constipation Assessment Scale (CAS), a total of 8 questions, 0 points: no, 1 point: yes, but not severe, 2 points. Very serious, the higher the score (0-16 points), the more severe the constipation symptoms. Assessment from the first day to the seventh day after treatment
Primary The Bristol Stool Form Scale bach's alpha of The Bristol Stool Form Scale. Classification: Type 1: hard balls (difficult to pass through), Type 2: sausage-like, but with uneven surface Type 3: sausage-like, but with cracks on the surface, Type 4: like sausage or snake Surface is smooth, type 5: soft lumps with smooth broken edges (easy to pass), type 6: fluffy lumps with rough edges, mushy stool, type 7: watery, no solid lumps (completely liquid), type 1 Types 3 and 2 indicate constipation; Types 3 and 4 are ideal stool shapes, especially Type 4 is the easiest to defecate; Types 5 to 7 are likely to have diarrhea Assessment from the first day to the seventh day after treatment
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