- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05612646
The Effect of Acupressure in Improving Constipation Among Inpatients in Neurology Departments
Taiwan Taichung Veterans General Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan, 40705
- 1650 Taiwan Boulevard Sect. 4
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 20 years old
- Established diagnosis of stroke (ischemic, hemorrhagic acute phase)
- NIHSS 1-20 points
- Undiagnosed within three months before admission With intestinal disease and no rectal resection
- meeting the diagnostic criteria for functional constipation (Rome IV).
Exclusion Criteria:
- Abdominal surgery or abdominal radiotherapy within three months
- Abdominal cancer including liver, large intestine, lymph, and pelvic cavity, etc.,
- Massive ascites
- There are implants in the abdominal cavity, such as V-P Shunt, L-P Shunt, CAPD, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: routine nursing and fake acupressure
control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization.
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control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization.
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The constipation assessment scale scores
Time Frame: Assessment from the first day to the seventh day after treatment
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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.
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Assessment from the first day to the seventh day after treatment
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The Bristol Stool Form Scale
Time Frame: Assessment from the first day to the seventh day after treatment
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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
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Assessment from the first day to the seventh day after treatment
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Collaborators and Investigators
Investigators
- Study Chair: Hsiao-Chi Nieh, MSC, Head Nurse
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Epub 2015 Dec 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF20208B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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