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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05506397
Other study ID # ErciyesU2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2021
Est. completion date November 30, 2021

Study information

Verified date August 2022
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was carried out to determine the effect of acupressure applied to LI4, CV12, ST25 and ST36 acupuncture points for a total of 21 minutes, three to each point, on the symptoms of constipation and quality of life of elderly individuals.


Description:

The study is a qualitative and quantitative mixed method, double-blind, randomized, placebo-controlled, pretest-posttest control group study. In this study; a total of 81 elderly individuals over the age of 65 and diagnosed with constipation in a family health center were included, 41 individuals in the acupressure group and 40 individuals in the placebo control group. Ethics committee approval, informed voluntary consent of the elderly and all other necessary permissions to conduct the study were obtained before the study. The data of the study were collected using the Individual Identification Form, the Constipation Assessment Scale (CAS), the Constipation Quality of Life Scale (PAC-QOL), the Visual Analog Scale (VAS), the Individual Follow-up Form and the Semi-Structured Interview Form. Acupressure was applied to individuals in the acupressure group every day for 12 days, and placebo acupressure was applied to individuals in the placebo acupressure group at the same time and in line with the same protocol. In addition, individual in-depth interviews were conducted with the individuals in the acupressure group after the applications were completed. Quantitative data were evaluated using the IBM SPSS Statistics for Windows 24.0 package program. In the evaluation of quantitative data; Independent groups t test / Mann Whitney U test, dependent groups t-test, two-way mixed pattern ANOVA, multiple regression analysis (enter method) were used and p<0.05 value was considered statistically significant. In the evaluation of qualitative data, descriptive and content analysis methods were used.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date November 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Aged 65 and over, - Able to answer cognitive questions - Able to do daily tasks unaided - Experiencing two or more of the Rome IV criteria Exclusion Criteria: - Communication and adaptation difficulties, - Malignant, intestinal obstruction, fecal incontinence, diarrhea, irritable bowel syndrome, abdominal infection, etc. have a contraindication to continue the intervention, addicted to bed - Chronic pain requiring long-term analgesic intake and using psychiatric medication,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupressure
Acupressure is a technique based on stimulating certain points on the body with stimulation methods such as hands and fingers.

Locations

Country Name City State
Turkey Erciyes University Kayseri Kayseri?

Sponsors (3)

Lead Sponsor Collaborator
TC Erciyes University Kayseri City Hospital, Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Jung ES, Chang AK. Effects of Auricular Acupressure in Patients on Hemodialysis. J Nurs Res. 2020 Aug;28(4):e106. doi: 10.1097/jnr.0000000000000378. — View Citation

Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. J Pain Symptom Manage. 2011 Oct;42(4):589-603. doi: 10.1016/j.jpainsymman.2011.01.007. Epub 2011 Apr 30. Review. — View Citation

Shin J, Park H. Effects of Auricular Acupressure on Constipation in Patients With Breast Cancer Receiving Chemotherapy: A Randomized Control Trial. West J Nurs Res. 2018 Jan;40(1):67-83. doi: 10.1177/0193945916680362. Epub 2016 Nov 30. — View Citation

Wang PM, Hsu CW, Liu CT, Lai TY, Tzeng FL, Huang CF. Effect of acupressure on constipation in patients with advanced cancer. Support Care Cancer. 2019 Sep;27(9):3473-3478. doi: 10.1007/s00520-019-4655-1. Epub 2019 Jan 24. Erratum in: Support Care Cancer. 2020 Mar;28(3):1535. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Constipation Assessment Scale (CAS) It was used to evaluate the symptoms of constipation. Change from Baseline symptoms of constipation at 12 days
Secondary Constipation Quality of Life Scale (PAC-QOL) It was used to evaluate the quality of life. Change from baseline constipation-related quality of life at 12 days
Secondary Visual Analog Scale (VAS) It was used to assess the level of defecation comfort. Change from baseline defecation comfort at 12 days
Secondary Number of Defecation 12-day total number of defecations Change from baseline number of defecations at 12 days
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