search
Back to results

The Efficacy of Acupressure in Managing Opioid-induced Constipation

Primary Purpose

Opioid-induced Bowel Dysfunction, Constipation Drug Induced

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Accupressure
Sponsored by
Istanbul Aydın University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid-induced Bowel Dysfunction focused on measuring Acupressure, Constipation, Opioids-induced constipation, Complementary medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istanbul Aydin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupressure group

Control group

Arm Description

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.

No intervention will be applied

Outcomes

Primary Outcome Measures

Patient Information Form
The descriptive characteristics, age, gender, marital status, education status, diagnosis are included. It is 10 items in total.
Defecation diary- the amount of stool
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.
Defecation diary - stool consistency
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.
Defecation diary - straining during defecation
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.
Defecation diary - feeling of incomplete emptying after defecation
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.
Visual Analog Scale
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.
Constipation Quality of Life Scale
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.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2021
Last Updated
May 5, 2021
Sponsor
Istanbul Aydın University
Collaborators
Acibadem University, Istanbul University
search

1. Study Identification

Unique Protocol Identification Number
NCT04876508
Brief Title
The Efficacy of Acupressure in Managing Opioid-induced Constipation
Official Title
The Efficacy of Acupressure in Managing Opioid-induced Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Aydın University
Collaborators
Acibadem University, Istanbul University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-induced Bowel Dysfunction, Constipation Drug Induced
Keywords
Acupressure, Constipation, Opioids-induced constipation, Complementary medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be applied
Intervention Type
Other
Intervention Name(s)
Accupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Information Form
Description
The descriptive characteristics, age, gender, marital status, education status, diagnosis are included. It is 10 items in total.
Time Frame
Baseline
Title
Defecation diary- the amount of stool
Description
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.
Time Frame
patients will record their defecation status for 4 weeks each time they defecate.
Title
Defecation diary - stool consistency
Description
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.
Time Frame
patients will record their defecation status for 4 weeks each time they defecate.
Title
Defecation diary - straining during defecation
Description
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.
Time Frame
patients will record their defecation status for 4 weeks each time they defecate.
Title
Defecation diary - feeling of incomplete emptying after defecation
Description
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.
Time Frame
patients will record their defecation status for 4 weeks each time they defecate.
Title
Visual Analog Scale
Description
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.
Time Frame
this assessment on a daily basis, and a one-week total score was obtained for each item
Title
Constipation Quality of Life Scale
Description
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.
Time Frame
Baseline and at the end of the fourth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DILEK YILDIRIM, PhD
Phone
05331421987
Email
dilekaticiyildirim@gmail.com
Facility Information:
Facility Name
Istanbul Aydin University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DİLEK YILDIRIM, PhD
Phone
444 1 428
Email
dilekyildirim@aydin@edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35257230
Citation
Yildirim D, Kocatepe V, Talu GK. The efficacy of acupressure in managing opioid-induced constipation in patients with cancer: A single-blind randomized controlled trial. Support Care Cancer. 2022 Jun;30(6):5201-5210. doi: 10.1007/s00520-022-06947-1. Epub 2022 Mar 7.
Results Reference
derived

Learn more about this trial

The Efficacy of Acupressure in Managing Opioid-induced Constipation

We'll reach out to this number within 24 hrs