Clinical trial NCT05612646: The Effect of Acupressure in Improving Constipation Among Inpatients in Neurology Departments
Official title: Taiwan Taichung Veterans General Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: acupressure, constipation,
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment A two-group controlled, randomized study, the intervention groups: receiving acupressure on 3 acupoints (Tianshu, ST25: Stomach Meridian 25; Zhongwan CV12: Conception Vessel 12; Qihai CV6: Meridian Vessel 6), control groups: receiving routine nursing and fake acupressure.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The constipation assessment scale scores
timeFrame: Assessment from the first day to the seventh day after treatment
measure: The Bristol Stool Form Scale
timeFrame: Assessment from the first day to the seventh day after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: 1650 Taiwan Boulevard Sect. 4
Study officials:
affiliation: Head Nurse
name: Hsiao-Chi Nieh, MSC
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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. Epub 2015 Dec 21.