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Acupressure for Constipation in the Elderly

Primary Purpose

Constıpatıon

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constıpatıon focused on measuring Acupressure, Constipation, Quality of life, Elderly people, Nursing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupressure (intervention group)

control group

Arm Description

Acupressure was applied to individuals in the acupressure group every day for 12 days.

Placebo acupressure was applied to the individuals in the placebo acupressure group in accordance with the same protocol.

Outcomes

Primary Outcome Measures

Constipation Assessment Scale (CAS)
It was used to evaluate the symptoms of constipation.

Secondary Outcome Measures

Constipation Quality of Life Scale (PAC-QOL)
It was used to evaluate the quality of life.
Visual Analog Scale (VAS)
It was used to assess the level of defecation comfort.
Number of Defecation
12-day total number of defecations

Full Information

First Posted
July 23, 2022
Last Updated
August 17, 2022
Sponsor
TC Erciyes University
Collaborators
Nigde Omer Halisdemir University, Kayseri City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05506397
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
Collaborators
Nigde Omer Halisdemir University, Kayseri City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constıpatıon
Keywords
Acupressure, Constipation, Quality of life, Elderly people, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, placebo-controlled, pretest-posttest control group study.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
A double-blind design was applied, including participants, interviewers and outcomes assessors.
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupressure (intervention group)
Arm Type
Experimental
Arm Description
Acupressure was applied to individuals in the acupressure group every day for 12 days.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Placebo acupressure was applied to the individuals in the placebo acupressure group in accordance with the same protocol.
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
Acupressure is a technique based on stimulating certain points on the body with stimulation methods such as hands and fingers.
Primary Outcome Measure Information:
Title
Constipation Assessment Scale (CAS)
Description
It was used to evaluate the symptoms of constipation.
Time Frame
Change from Baseline symptoms of constipation at 12 days
Secondary Outcome Measure Information:
Title
Constipation Quality of Life Scale (PAC-QOL)
Description
It was used to evaluate the quality of life.
Time Frame
Change from baseline constipation-related quality of life at 12 days
Title
Visual Analog Scale (VAS)
Description
It was used to assess the level of defecation comfort.
Time Frame
Change from baseline defecation comfort at 12 days
Title
Number of Defecation
Description
12-day total number of defecations
Time Frame
Change from baseline number of defecations at 12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sultan TAŞCI, Prof. Dr.
Organizational Affiliation
TC Erciyes University
Official's Role
Study Director
Facility Information:
Facility Name
Erciyes University
City
Kayseri
State/Province
Kayseri̇
ZIP/Postal Code
38280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol
IPD Sharing Time Frame
unlimited
IPD Sharing Access Criteria
unlimited
Citations:
PubMed Identifier
27903827
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.
Results Reference
background
PubMed Identifier
30675666
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.
Results Reference
background
PubMed Identifier
32379107
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.
Results Reference
background
PubMed Identifier
21531533
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://tez.yok.gov.tr/UlusalTezMerkezi/

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Acupressure for Constipation in the Elderly

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