Acupressure for Constipation in the Elderly

August 17, 2022 updated by: Tuğba AYDEMİR, TC Erciyes University

The Effect of Acupressure on Constıpatıon Symptoms and Quality of Lıfe in Elderly People

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kayseri̇
      • Kayseri, Kayseri̇, Turkey, 38280
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acupressure (intervention group)
Acupressure was applied to individuals in the acupressure group every day for 12 days.
Other: Acupressure
Acupressure is a technique based on stimulating certain points on the body with stimulation methods such as hands and fingers.
PLACEBO_COMPARATOR: control group
Placebo acupressure was applied to the individuals in the placebo acupressure group in accordance with the same protocol.
Other: Acupressure
Acupressure is a technique based on stimulating certain points on the body with stimulation methods such as hands and fingers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constipation Assessment Scale (CAS)
Time Frame: Change from Baseline symptoms of constipation at 12 days
It was used to evaluate the symptoms of constipation.
Change from Baseline symptoms of constipation at 12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constipation Quality of Life Scale (PAC-QOL)
Time Frame: Change from baseline constipation-related quality of life at 12 days
It was used to evaluate the quality of life.
Change from baseline constipation-related quality of life at 12 days
Visual Analog Scale (VAS)
Time Frame: Change from baseline defecation comfort at 12 days
It was used to assess the level of defecation comfort.
Change from baseline defecation comfort at 12 days
Number of Defecation
Time Frame: Change from baseline number of defecations at 12 days
12-day total number of defecations
Change from baseline number of defecations at 12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Collaborators

Nigde Omer Halisdemir University
Kayseri City Hospital

Investigators

  • Study Director: Sultan TAŞCI, Prof. Dr., TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 24, 2021

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

November 30, 2021

Study Registration Dates

First Submitted

July 23, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (ACTUAL)

August 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ErciyesU2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol

IPD Sharing Time Frame

unlimited

IPD Sharing Access Criteria

unlimited

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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