Acupressure for Constipation in the Elderly

NCT ID: NCT05805787

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, pretest-posttest control group study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Acupressure group

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.

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

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.

Control group

No intervention will be applied

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupressure

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 60 and over,
* Experiencing two or more of the Rome IV criteria
* Not following a special nutrition program
* Not using laxatives

Exclusion Criteria

* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duzce University

OTHER

Sponsor Role collaborator

University of Yalova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esra Usta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Yalova

Locations

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Yalova University

Yalova, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Esra Usta, PhD

Role: CONTACT

+905552801691

Facility Contacts

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Esra Usta, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 30788281 (View on PubMed)

Ho 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.

Reference Type RESULT
PMID: 32814493 (View on PubMed)

Other Identifiers

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Yalova Uni.

Identifier Type: -

Identifier Source: org_study_id

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