ConstipationNCT05805787
Acupressure for Constipation in the Elderly
A study testing Acupressure in people with Constipation, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
This study will carried out to determine the effect of acupressure applied to Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) acupuncture points for a total of 6 minutes, two to each point, on the symptoms of constipation in the elderly people receiving institutional care. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2023to Jul 2023
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 and over,
- Experiencing two or more of the Rome IV criteria
- Not following a special nutrition program
- Not using laxatives
Who cannot join
- Have a communication problem
- Having high cognitive impairment (according to the Mini-Cog test)
- Addicted to bed
- Having musculoskeletal problems (eg amputation of the acupuncture site)
- Having received acupressure / acupuncture treatment up to 8 weeks before the study
- Having skin problems at acupressure points (eg, skin rash, infection)
- History of gastrointestinal disorders such as irritable bowel syndrome, rectal prolapse, anal fissure, volvulus, and bowel obstruction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yalova University
Yalova
Esra Usta, PhD
Esra Usta, PhD
About this study
Official title: The Effect of Acupressure on Constipation Symptoms in Elderly
This study will carried out to determine the effect of acupressure applied to Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) acupuncture points for a total of 6 minutes, two to each point, on the symptoms of constipation in the elderly people receiving institutional care.
Read the detailed description
In a randomized controlled study will be evaluated the effect of acupressure application on constipation symptoms in the elderly people receiving institutional care. The study population will be conducted of 193 elderly individuals living in a Nursing and Rehabilitation Center under the Directorate of Family, Labor and Social Services in a province of Turkey. After explaining the purpose of the study and obtaining written consent from the patients, those with constipation will be determined. Those with constipation will be determined by applying The Patient Identification Form, Mini-Cog© Test, Constipation Diagnosis Form to the entire population. The sample of the study will consist of all patients who meet the inclusion criteria and who are willing to participate in the study. The sample size calculated using a t-test in independent samples with the G Power 3.1.3 software. In a randomized controlled study by Abbasi et al. (2019), it was seen that the effect size of acupressure on constipation was 0.99. When a single direction calculation was performed with a 95% confidence interval, 80% power, a ratio of 1:1 for Intervention and Control group, and a strong effect size (0.80), it was determined that it was necessary to choose a minimum of 21 patients for each group, that is, a total of 42 patients. Considering that there may be losses in the application and follow-up period, the number of samples will be increased by 10% and 23 people will be included in each group. The patients enrolled in the study will be divided into intervention and control groups using the previously prepared randomization checklist. After the Intervention and Control group is determined, all patients will be followed for a total 10 days and the Bristol Stool Scale and Constipation Assessment Scale will be applied daily. Acupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes. No attempt will be made to the control group. All patients will be followed during the application (14 days) and for 10 days after the application and the Bristol Stool Scale and Constipation Assessment Scale will be applied daily. After the data is coded and transferred to the computer environment, it will be evaluated with the SPSS 21.0 program. Pre-test post-test results of the Intervention and Control groups will be analyzed for variance in the t-test and repeated measurements applied in independent groups. Confidence interval for statistical significance will be set as <0.05.
- Conditions
- Constipation
- Being tested
- Acupressure
- Keywords
- elderly, defecation, laxatives, old age homes
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | Acupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes. Receives: Other: Acupressure |
| Control group | No intervention | No intervention will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Assessment Scale
It will be used to evaluate the symptoms of constipation.Constipation Assessment Scale prepared according to the Rome IV criteria for the diagnosis of constipation. According to the criteria, 2 or more of the following symptoms must have started at least 6 months ago and continued for the last 3 months.
- Straining more than 25% of defecations. ii. Lumpy or hard stools (The Bristol Stool Form Scale type 1 or 2) more than 25% of defecations. iii. Sensation of incomplete evacuation more than one-fourth (25%) of defecations. iv. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations.
- Manual maneuvers to facilitate more than one-fourth (25%) of defecations. vi. Fewer than three spontaneous bowel movements per week
Measured: Change from Baseline symptoms of constipation at 24 days
Bristol Stool Scale
It will be used to determine the characteristics of the stool. This helps assess how long the stool has spent in the bowel. Types 1 and 2 indicate an unusually hard stool and constipation. types 6 and 7 are unusually loose and may indicate diarrhea. A normal stool should be a type 3, 4, and 5.
Measured: Change from Baseline symptoms of constipation at 24 days
Secondary outcomes (1)
Number of Defecation
24-day total number of defecations
Measured: Change from baseline number of defecations at 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- 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
- randomized, pretest-posttest control group study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Collaborators
- Duzce University
- Responsible party
- Sponsor
- Investigators
- Esra Usta, PhD, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805787
- Sponsor's protocol ID
- Yalova Uni.
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 30788281Ho MH, Chang HCR, Liu MF, Yuan L, Montayre J. Effectiveness of acupoint pressure on older people with constipation in nursing homes: a double-blind quasi-experimental study. Contemp Nurse. 2020 Oct-Dec;56(5-6):417-427. doi: 10.1080/10376178.2020.1813042. Epub 2020 Sep 18.
PubMed 32814493
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Constipation Symptoms in Elderly
- ClinicalTrials.gov ID
- NCT05805787
- Acronym / sponsor ID
- Yalova Uni.
- Conditions
- Constipation
- Keywords
- elderly, defecation, laxatives, old age homes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Collaborators
- Duzce University
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 10 Apr 2023 (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.
This study will carried out to determine the effect of acupressure applied to Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) acupuncture points for a total of 6 minutes, two to each point, on the symptoms of constipation in the elderly people receiving institutional care.
Detailed description
In a randomized controlled study will be evaluated the effect of acupressure application on constipation symptoms in the elderly people receiving institutional care. The study population will be conducted of 193 elderly individuals living in a Nursing and Rehabilitation Center under the Directorate of Family, Labor and Social Services in a province of Turkey. After explaining the purpose of the study and obtaining written consent from the patients, those with constipation will be determined. Those with constipation will be determined by applying The Patient Identification Form, Mini-Cog© Test, Constipation Diagnosis Form to the entire population. The sample of the study will consist of all patients who meet the inclusion criteria and who are willing to participate in the study. The sample size calculated using a t-test in independent samples with the G Power 3.1.3 software. In a randomized controlled study by Abbasi et al. (2019), it was seen that the effect size of acupressure on constipation was 0.99. When a single direction calculation was performed with a 95% confidence interval, 80% power, a ratio of 1:1 for Intervention and Control group, and a strong effect size (0.80), it was determined that it was necessary to choose a minimum of 21 patients for each group, that is, a total of 42 patients. Considering that there may be losses in the application and follow-up period, the number of samples will be increased by 10% and 23 people will be included in each group. The patients enrolled in the study will be divided into intervention and control groups using the previously prepared randomization checklist. After the Intervention and Control group is determined, all patients will be followed for a total 10 days and the Bristol Stool Scale and Constipation Assessment Scale will be applied daily. Acupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes. No attempt will be made to the control group. All patients will be followed during the application (14 days) and for 10 days after the application and the Bristol Stool Scale and Constipation Assessment Scale will be applied daily. After the data is coded and transferred to the computer environment, it will be evaluated with the SPSS 21.0 program. Pre-test post-test results of the Intervention and Control groups will be analyzed for variance in the t-test and repeated measurements applied in independent groups. Confidence interval for statistical significance will be set as <0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized, pretest-posttest control group study.
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureAcupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes. |
| Control group | No intervention | –No intervention will be applied |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 and over,
- Experiencing two or more of the Rome IV criteria
- Not following a special nutrition program
- Not using laxatives
Key exclusion criteria (7 listed)
- Have a communication problem
- Having high cognitive impairment (according to the Mini-Cog test)
- Addicted to bed
- Having musculoskeletal problems (eg amputation of the acupuncture site)
- Having received acupressure / acupuncture treatment up to 8 weeks before the study
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 |
|---|---|---|
| AcupressureAcupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes. | Other | Acupressure group |
Primary outcome
Constipation Assessment Scale
Time frame: Change from Baseline symptoms of constipation at 24 days
It will be used to evaluate the symptoms of constipation.Constipation Assessment Scale prepared according to the Rome IV criteria for the diagnosis of constipation. According to the criteria, 2 or more of the following symptoms must have started at least 6 months ago and continued for the last 3 months. i. Straining more than 25% of defecations. ii. Lumpy or hard stools (The Bristol Stool Form Scale type 1 or 2) more than 25% of defecations. iii. Sensation of incomplete evacuation more than one-fourth (25%) of defecations. iv. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations. v. Manual maneuvers to facilitate more than one-fourth (25%) of defecations. vi. Fewer than three spontaneous bowel movements per week
Bristol Stool Scale
Time frame: Change from Baseline symptoms of constipation at 24 days
It will be used to determine the characteristics of the stool. This helps assess how long the stool has spent in the bowel. Types 1 and 2 indicate an unusually hard stool and constipation. types 6 and 7 are unusually loose and may indicate diarrhea. A normal stool should be a type 3, 4, and 5.
1 secondary outcome
Number of Defecation
Time frame: Change from baseline number of defecations at 24 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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 32814493Ho MH, Chang HCR, Liu MF, Yuan L, Montayre J. Effectiveness of acupoint pressure on older people with constipation in nursing homes: a double-blind quasi-experimental study. Contemp Nurse. 2020 Oct-Dec;56(5-6):417-427. doi: 10.1080/10376178.2020.1813042. Epub 2020 Sep 18.
- 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.
Esra Usta, PhD principal investigator
University of Yalova
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 in people with Constipation, run by University of Yalova at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Apr 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Usta, PhD (+905552801691, esra.usta@yalova.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Assessment Scale (time frame: Change from Baseline symptoms of constipation at 24 days). 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 NCT05805787, which also lists 2 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 14 Apr 2023.