Clinical trial NCT05805787: Acupressure for Constipation in the Elderly
Official title: The Effect of Acupressure on Constipation Symptoms in Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Keywords: elderly
defecation
laxatives
old age homes
Lead sponsor: University of Yalova
Sponsor class: OTHER
Collaborators: name: Duzce University
First posted: 2023-04-10
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, pretest-posttest control group study.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Constipation Assessment Scale
timeFrame: Change from Baseline symptoms of constipation at 24 days
measure: Bristol Stool Scale
timeFrame: Change from Baseline symptoms of constipation at 24 days
Secondary outcomes:
measure: Number of Defecation
timeFrame: Change from baseline number of defecations at 24 days
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Yalova University
Study officials:
affiliation: Yalova University
name: Esra Usta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.