The Efficacy of Acupressure in Managing Opioid-induced Constipation

NCT04876508 | Unknown

• 1 other identifier: OPIOID-INDUCED CONSTIPATION
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-induced Bowel Dysfunction; Constipation Drug Induced

Keywords

Acupressure; Constipation; Opioids-induced constipation; Complementary medicine

Outcome Measures

Primary Outcomes (7)

• Patient Information Form

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Acupressure group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention will be applied

Interventions

Accupressure OTHER

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.

Acupressure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Aydın University: lead
• Acibadem University: collaborator
• Istanbul University: collaborator

Study Sites (1)

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 35257230 DERIVED

MeSH Terms

Conditions

Opioid-Induced Constipation; Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

DILEK YILDIRIM, PhD

CONTACT

05331421987; dilekaticiyildirim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 6, 2021
• Study Start: August 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 30, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)