The Efficacy of Acupressure in Managing Opioid-induced Constipation

May 5, 2021 updated by: DİLEK YILDIRIM, Istanbul Aydın University
In a randomized controlled study to evaluate the effect of acupressure application on opioid-related constipation, the Patient Identification Form, Defecation Diary, Visual Analog Scale and Constipation Quality of Life Scale will be applied after obtaining written informed consent from the patients. Patients in the experimental group will be given acupressure once a day for 7 consecutive days. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the patients are in supine position, pressure will be applied to each acupressure point around the navel, respectively, Zhongwan (CV12), Guanyuan (CV4) and Tianshu (ST25) for 2 minutes for a total of 6 minutes. No attempt will be made to the control group. All patients will be followed for a total of 4 weeks and the Defecation Diary and Visual Comparison Scale will be applied weekly. 4. Constipation Quality of Life Scale will be applied again at the end of the week. The study was planned to examine the effect of acupressure on opioid-related constipation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Constipation symptom, which is very common in patients using opioids, affects the quality of life of the patients and may increase the severity of other symptoms. Pharmacological and non-pharmacological methods can be used in the management of opioid-associated constipation. One of the non-pharmacological approaches used is acupressure application. The effects of acupressure to increase bowel movements have been shown in studies. The study was planned to examine the effect of acupressure on opioid-related constipation. The goals that achieve this goal; To evaluate gastrointestinal functions in patients using opioid drugs, to examine and alleviate the effect of acupressure application on gastrointestinal functions (stool frequency, stool type, abdominal distension, abdominal pain, abdominal tenderness) in these patients, their quality of life (anxiety / anxiety states, physical, psychological discomfort) to evaluate and improve situations, satisfaction situations).

Study Population and Sample The research will be conducted in Istanbul University Istanbul Faculty of Medicine Hospital Algology Outpatient Clinic and Service. The universe of the study will consist of all patients followed in the Algology outpatient clinic and service. 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 patients enrolled in the study will be divided into intervention and control groups using the previously prepared randomization checklist.

Procedures In a randomized controlled study to evaluate the effect of acupressure application on opioid-related constipation, the Patient Identification Form, Defecation Diary, Visual Comparison Scale and Constipation Quality of Life Scale will be applied after obtaining written informed consent from the patients. Patients in the intervention group will be given acupressure once a day for 7 consecutive days. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the patients are in supine position, pressure will be applied to each acupressure point around the navel, respectively, Zhongwan (CV12), Guanyuan (CV4) and Tianshu (ST25) for 2 minutes for a total of 6 minutes. No attempt will be made to the control group. All patients will be followed for a total of 4 weeks and the Defecation Diary and Visual Comparison Scale will be applied weekly.No intervention will be applied to the control group.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 and over who agreed to participate in the study,
  • Cooperative and have no communication problem,
  • Who have been on opioid therapy for at least 2 weeks,
  • Can be fed orally,
  • Constipation diagnosed by the physician,
  • Patients whose constipation continues despite receiving laxative therapy for at least 1 week

Exclusion Criteria:

  • Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression)
  • Have thrombocytopenia (thrombocyte count <50,000 / μL),
  • Have a gastrointestinal tumor,
  • Having a history of abdominal hernia, bowel cancer and abdominal surgery,
  • Having intraabdominal infection,
  • Have irritable bowel syndrome and intestinal obstruction,
  • Patients with inflammatory bowel disease will be excluded.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure group
Patients in the acupressure group will be given acupressure once a day for 7 consecutive days. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the patients are in supine position, pressure will be applied to each acupressure point around the navel, respectively, Zhongwan (CV12), Guanyuan (CV4) and Tianshu (ST25) for 2 minutes for a total of 6 minutes.
Other: Accupressure
Patients in the experimental group will be given acupressure once a day for 7 consecutive days. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the patients are in supine position, pressure will be applied to each acupressure point around the navel, respectively, Zhongwan (CV12), Guanyuan (CV4) and Tianshu (ST25) for 2 minutes for a total of 6 minutes.
No Intervention: Control group
No intervention will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Information Form
Time Frame: Baseline
The descriptive characteristics, age, gender, marital status, education status, diagnosis are included. It is 10 items in total.
Baseline
Defecation diary- the amount of stool
Time Frame: patients will record their defecation status for 4 weeks each time they defecate.

None (0) Less (+) (1) Medium (++) (2) It is scored as extra (+++) (3).

As the score increases, constipation decreases. Includes a minimum of 0 and a maximum of 3 points.
patients will record their defecation status for 4 weeks each time they defecate.
Defecation diary - stool consistency
Time Frame: patients will record their defecation status for 4 weeks each time they defecate.

Small, hard like marble (1 point) Bulky, hard (2 point) Normal (3 point) Soft (4 point) Aqueous (5 point)

As the score increases, constipation decreases. Includes a minimum of 1 and a maximum of 5 points.
patients will record their defecation status for 4 weeks each time they defecate.
Defecation diary - straining during defecation
Time Frame: patients will record their defecation status for 4 weeks each time they defecate.

Defecation without straining (1) Straining at the beginning of defecation (2) Straining in half defecation (3) Straining during all defecation (4)

The higher the score, the higher the severity of constipation. Includes a minimum of 1 and a maximum of 4 points.
patients will record their defecation status for 4 weeks each time they defecate.
Defecation diary - feeling of incomplete emptying after defecation
Time Frame: patients will record their defecation status for 4 weeks each time they defecate.

Present after defecation (1) None after defecation (0)

The higher the score, the higher the severity of constipation. Includes a minimum of 0 and a maximum of 1 points.
patients will record their defecation status for 4 weeks each time they defecate.
Visual Analog Scale
Time Frame: this assessment on a daily basis, and a one-week total score was obtained for each item
Pamuk et al. The form developed by (2003) includes 6 questions about the severity of the constipation symptoms. The Visual Analog Scale is a 10 cm horizontal line with 0 at one end and 10 at the other. The patient will be asked to mark the severity of each of the constipation symptoms on the horizontal line, giving a score between 0 and 10. The patients made this assessment daily, and by adding the scores, the total score average for one week for each item will be obtained. Minimum 0 Maximum 60 points are obtained from the scale. As the score increases, the severity of constipation increases.
this assessment on a daily basis, and a one-week total score was obtained for each item
Constipation Quality of Life Scale
Time Frame: Baseline and at the end of the fourth week
It will be used in order to determine the effects of constipation related to opioid treatment on daily life and to measure the quality of life. The highest score that can be obtained from the scale is 140 and the lowest score is 28. It is thought that as the scores obtained from the scale increase, the quality of life is also negatively affected.
Baseline and at the end of the fourth week

Collaborators and Investigators

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

Sponsor

Istanbul Aydın University

Collaborators

Istanbul University
Acibadem 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)

August 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 1, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPIOID-INDUCED CONSTIPATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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