NCT05612646

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

October 25, 2022

Last Update Submit

May 7, 2023

Conditions

Keywords

acupressure, constipation,

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

routine nursing and fake acupressure

ACTIVE COMPARATOR

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

Procedure: routine nursing and fake acupressure

acupressure

EXPERIMENTAL

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.

Procedure: Acupressure

Interventions

AcupressurePROCEDURE

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.

acupressure

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

routine nursing and fake acupressure

Eligibility Criteria

Age20 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1650 Taiwan Boulevard Sect. 4

Taichung, 40705, Taiwan

Location

Related Publications (6)

  • 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.

  • Nieh HC, Wu PO, Ou SF, Li HP, Chen JP. Effect of acupressure on alleviating constipation among inpatients with stroke during the acute phase: A randomized controlled trial. Complement Ther Clin Pract. 2023 Nov;53:101801. doi: 10.1016/j.ctcp.2023.101801. Epub 2023 Sep 22.

MeSH Terms

Conditions

Constipation

Interventions

Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hsiao-Chi Nieh, MSC

    Head Nurse

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 10, 2022

Study Start

September 11, 2020

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations