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The Effect of Acupressure in Improving Constipation Among Inpatients in Neurology Departments

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupressure
routine nursing and fake acupressure
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation focused on measuring acupressure, constipation,

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 1650 Taiwan Boulevard Sect. 4

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

routine nursing and fake acupressure

acupressure

Arm Description

control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2022
Last Updated
May 7, 2023
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05612646
Brief Title
The Effect of Acupressure in Improving Constipation Among Inpatients in Neurology Departments
Official Title
Taiwan Taichung Veterans General Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
acupressure, constipation,

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Use the random number generator of EXCEL to generate the random number assigned by the computer, and put the serial number in the sealed envelope in sequence. After the patients completed the pre-test, the sealed envelopes were opened in sequence, and the patients were randomly assigned to the experimental group and the routine care group. The study used an assessor blinding design, that is, the data collectors were unaware of the patient group assignments until the end of the study
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
routine nursing and fake acupressure
Arm Type
Active Comparator
Arm Description
control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization.
Arm Title
acupressure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupressure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
routine nursing and fake acupressure
Intervention Description
control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization.
Primary Outcome Measure Information:
Title
The constipation assessment scale scores
Description
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.
Time Frame
Assessment from the first day to the seventh day after treatment
Title
The Bristol Stool Form Scale
Description
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
Time Frame
Assessment from the first day to the seventh day after treatment

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Chi Nieh, MSC
Organizational Affiliation
Head Nurse
Official's Role
Study Chair
Facility Information:
Facility Name
1650 Taiwan Boulevard Sect. 4
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30788281
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.
Results Reference
result
PubMed Identifier
31945360
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.
Results Reference
result
PubMed Identifier
31780015
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.
Results Reference
result
PubMed Identifier
31426687
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.
Results Reference
result
PubMed Identifier
26690980
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.
Results Reference
result

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The Effect of Acupressure in Improving Constipation Among Inpatients in Neurology Departments

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