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Acupressure for Constipation in the Elderly

Primary Purpose

Constipation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Sponsored by
University of Yalova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation focused on measuring elderly, defecation, laxatives, old age homes

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yalova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupressure group

Control group

Arm Description

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 intervention will be applied

Outcomes

Primary Outcome Measures

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. 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
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.

Secondary Outcome Measures

Number of Defecation
24-day total number of defecations

Full Information

First Posted
March 26, 2023
Last Updated
April 11, 2023
Sponsor
University of Yalova
Collaborators
Duzce University
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1. Study Identification

Unique Protocol Identification Number
NCT05805787
Brief Title
Acupressure for Constipation in the Elderly
Official Title
The Effect of Acupressure on Constipation Symptoms in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Yalova
Collaborators
Duzce University

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
elderly, defecation, laxatives, old age homes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, pretest-posttest control group study.
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be applied
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Constipation Assessment Scale
Description
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
Time Frame
Change from Baseline symptoms of constipation at 24 days
Title
Bristol Stool Scale
Description
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.
Time Frame
Change from Baseline symptoms of constipation at 24 days
Secondary Outcome Measure Information:
Title
Number of Defecation
Description
24-day total number of defecations
Time Frame
Change from baseline number of defecations at 24 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Usta, PhD
Phone
+905552801691
Email
esra.usta@yalova.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Usta, PhD
Organizational Affiliation
Yalova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yalova University
City
Yalova
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Usta, PhD
First Name & Middle Initial & Last Name & Degree
Esra Usta, PhD
First Name & Middle Initial & Last Name & Degree
Özlem Altınbaş Akkaş, PhD
First Name & Middle Initial & Last Name & Degree
Serap Bayram, PhD

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
32814493
Citation
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.
Results Reference
result

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Acupressure for Constipation in the Elderly

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