Opioid-induced Bowel DysfunctionNCT04876508
The Efficacy of Acupressure in Managing Opioid-induced Constipation
A study testing Accupressure in people with Opioid-induced Bowel Dysfunction and Constipation Drug Induced, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-induced Bowel Dysfunction, Constipation Drug Induced
- What is being tested?
- Accupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Aydin University
Istanbul
DİLEK YILDIRIM, PhD, 444 1 428, dilekyildirim@aydin@edu.tr
About this study
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.
Read the 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.
- Being tested
- Accupressure
- Keywords
- Acupressure, Constipation, Opioids-induced constipation, Complementary medicine
- Medical subject headings
- Opioid-Induced Constipation, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Accupressure |
| Control group | No intervention | No intervention will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
The descriptive characteristics, age, gender, marital status, education status, diagnosis are included. It is 10 items in total.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at the end of the fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Aug 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-induced Bowel DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem University, Istanbul University
- Responsible party
- Principal investigator, DİLEK YILDIRIM, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876508
- Sponsor's protocol ID
- OPIOID-INDUCED CONSTIPATION
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35257230
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acupressure in Managing Opioid-induced Constipation
- ClinicalTrials.gov ID
- NCT04876508
- Acronym / sponsor ID
- OPIOID-INDUCED CONSTIPATION
- Keywords
- Acupressure, Constipation, Opioids-induced constipation, Complementary medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Collaborators
- Acibadem University, Istanbul University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AccupressurePatients 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. |
| Control group | No intervention | –No intervention will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccupressurePatients 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. | Other | Acupressure group |
Primary outcome
Patient Information Form
Time frame: Baseline
The descriptive characteristics, age, gender, marital status, education status, diagnosis are included. It is 10 items in total.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Derived from this study: PubMed 35257230Yildirim 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.
- Individual participant dataSharing planned: No
Related trials for Opioid-induced Bowel Dysfunction
Recruiting
Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)
Colorectal Cancer, Colorectal Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accupressure in people with Opioid-induced Bowel Dysfunction and Constipation Drug Induced, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DILEK YILDIRIM, PhD (05331421987, dilekaticiyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.