Clinical trial NCT04876508: The Efficacy of Acupressure in Managing Opioid-induced Constipation
Official title: The Efficacy of Acupressure in Managing Opioid-induced Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid-induced Bowel Dysfunction
Constipation Drug Induced
Keywords: Acupressure
Constipation
Opioids-induced constipation
Complementary medicine
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
Collaborators: name: Acibadem University
name: Istanbul University
First posted: 2021-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Patient Information Form
timeFrame: Baseline
measure: Defecation diary- the amount of stool
timeFrame: patients will record their defecation status for 4 weeks each time they defecate.
measure: Defecation diary - stool consistency
timeFrame: patients will record their defecation status for 4 weeks each time they defecate.
measure: Defecation diary - straining during defecation
timeFrame: patients will record their defecation status for 4 weeks each time they defecate.
measure: Defecation diary - feeling of incomplete emptying after defecation
timeFrame: patients will record their defecation status for 4 weeks each time they defecate.
measure: Visual Analog Scale
timeFrame: this assessment on a daily basis, and a one-week total score was obtained for each item
measure: Constipation Quality of Life Scale
timeFrame: Baseline and at the end of the fourth week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
Study officials:
References:
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.