Clinical trial NCT05506397: Acupressure for Constipation in the Elderly
Official title: The Effect of Acupressure on Constıpatıon Symptoms and Quality of Lıfe in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constıpatıon
Keywords: Acupressure
Constipation
Quality of life
Elderly people
Nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: Nigde Omer Halisdemir University
name: Kayseri City Hospital
First posted: 2022-08-18
Enrollment: 81
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, placebo-controlled, pretest-posttest control group study.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Constipation Assessment Scale (CAS)
timeFrame: Change from Baseline symptoms of constipation at 12 days
Secondary outcomes:
measure: Constipation Quality of Life Scale (PAC-QOL)
timeFrame: Change from baseline constipation-related quality of life at 12 days
measure: Visual Analog Scale (VAS)
timeFrame: Change from baseline defecation comfort at 12 days
measure: Number of Defecation
timeFrame: Change from baseline number of defecations at 12 days
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Kayseri̇
Study officials:
affiliation: TC Erciyes University
name: Sultan TAŞCI, Prof. Dr.
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.