Acupressure for Constipation in the Elderly

Constipation Clinical Trial

Official title:

The Effect of Acupressure on Constipation Symptoms in Elderly

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05805787
• Other study ID #: Yalova Uni.
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: July 2023

Study information

• Verified date: April 2023
• Source: University of Yalova
• Contact: Esra Usta, PhD
• Phone: +905552801691
• Email: esra.usta[@]yalova.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Yalova University	Yalova

Sponsors (2)

Lead Sponsor	Collaborator
University of Yalova	Duzce University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline symptoms of constipation at 24 days
Primary	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.	Change from Baseline symptoms of constipation at 24 days
Secondary	Number of Defecation	24-day total number of defecations	Change from baseline number of defecations at 24 days