ConstipationNCT05612646
The Effect of Acupressure in Improving Constipation Among Inpatients in Neurology Departments
A study testing Acupressure and routine nursing and fake acupressure in people with Constipation, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Acupressure and routine nursing and fake acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2020to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taiwan Taichung Veterans General Hospital
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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Acupressure, routine nursing and fake acupressure
- Keywords
- acupressure, constipation,
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureProcedure or surgery
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 acupressureProcedure or surgery
control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| routine nursing and fake acupressure | Active comparator | control groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization. Receives: 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. Receives: Procedure: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Assessment from the first day to the seventh day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start11 Sep 2020
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Chi Nieh, MSC, Study chair, Head Nurse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612646
- Sponsor's protocol ID
- CF20208B
- Status last verified
- May 2023
- First submitted
- 25 Oct 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30788281Bharucha 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.
PubMed 31945360Birimoglu 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.
PubMed 31780015Chen 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.
PubMed 31426687Chumpitazi 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.
PubMed 26690980Nieh 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.
PubMed 37793306
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Taichung Veterans General Hospital
- ClinicalTrials.gov ID
- NCT05612646
- Acronym / sponsor ID
- CF20208B
- Conditions
- Constipation
- Keywords
- acupressure, constipation,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| routine nursing and fake acupressure | Active comparator | Procedure: routine nursing and fake acupressurecontrol groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization. |
| acupressure | Experimental | Procedure: AcupressureThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureThe 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 or surgery | acupressure |
| routine nursing and fake acupressurecontrol groups: receiving routine nursing and fake acupressure to improve constipation for 7 days during hospitalization. | Procedure or surgery | routine nursing and fake acupressure |
Primary outcome
The constipation assessment scale scores
Time frame: Assessment from the first day to the seventh day after treatment
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
Time frame: Assessment from the first day to the seventh day after treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Results publication: PubMed 30788281Abbasi 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 publication: PubMed 31945360Bharucha 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 publication: PubMed 31780015Birimoglu 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 publication: PubMed 31426687Chen 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 publication: PubMed 26690980Chumpitazi 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.
- Derived from this study: PubMed 37793306Nieh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Chi Nieh, MSC study chair
Head Nurse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and routine nursing and fake acupressure in people with Constipation, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The constipation assessment scale scores (time frame: Assessment from the first day to the seventh day after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612646, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.