Opioid UseNCT05314335
Reflexology Socks and Opioid-induced Constipation
A study testing Reflexology socks+walking and Just walking in people with Opioid Use and Constipation, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Opioids are one of the most commonly used treatment approaches in the treatment of severe pain due to cancer and non-cancer causes. The most commonly reported side effect by patients related to opioid use is constipation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Constipation, Reflexology
- What is being tested?
- Reflexology socks+walking and Just walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2020to 7 Jul 2022
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are at least 18 years old ( ≥ 18 years old)
- Patients with a maximum age of 85 years (≤ 85 years old)
- Patients who volunteered to participate in the study
- Does not have any disability in communicating cognitively, mentally and verbally.
- Opioid treatment applied for approximately 2 weeks
- Those with constipation complaints
- At least one of the constipation problems (straining during bowel emptying, hard stool, feeling of incomplete evacuation, gas/bloating, rectal pressure/defecation sensation) that have been emptied less than 3 times a week since the opioid treatment started and/or developed due to opioid use patients
- Patients with a foot number between 37-44
Who cannot join
- Having a complaint of peripheral neuropathy
- Being diagnosed with diabetes
- Having impaired skin integrity
- Having any deformity of flat feet or feet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reflexology Socks On The Management of Opioid-Induced Constipation
Opioids are one of the most commonly used treatment approaches in the treatment of severe pain due to cancer and non-cancer causes. The most commonly reported side effect by patients related to opioid use is constipation. Opioid-related constipation, with an overall incidence of between 17% and 88%, requires a reduction in the treatment dose or drug rotation in some patients. It also makes it difficult for patients to comply with treatment. However, if the constipation due to opioid use is not managed properly and continues for a long time, many problems such as hemorrhoids and perforation, rectal pain and burning, intestinal rupture, anal fissure, diarrhea due to partial obstruction, urinary incontinence may develop.
It is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply.
The aim of this study is to examine whether reflexology stockings are an effective approach in reducing opioid-related constipation.
Read the detailed description
The basis of the physiopathological mechanism of constipation due to opioid use is the reducing effect on intestinal motility. There are opioid receptors called "mu" in the enteric nervous system. In patients using opioids, opioid agonists bind to these receptors. As a result of the binding of opioid agonists to the "mu" receptors, the release of excitatory and inhibitory neurotransmitters is inhibited and the coordinated rhythmic contractions required for bowel movements are reduced, as a result, peristaltic movements in the ileum and colon slow down and opioid-related intestinal dysfunction develops. With the prolonged stay of feces in the intestinal lumen, fluid absorption from the intestine increases and dry, hard stools are formed. Sphincter tone and non-impulsive contractions increase. As a result of all these effects, constipation develops.
In the management of constipation; In this study, both the effects of reflexology applied to the foot on the neuropeptide system and the effect of regulating electromagnetic transmissions were utilized. In a study conducted with the participation of children with cerebral palsy with constipation, it was reported that reflexology applied to the foot twice a week for 8 weeks had a positive effect on constipation. In a different study evaluating the effect of foot reflexology in patients with Multiple Sclerosis, it was reported that reflexology massage applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30-40 minutes once a week for 6 weeks reduced constipation. In a different study conducted with the participation of elderly patients, it was reported that foot reflexology applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30 minutes 3 times a week for 1 month resulted in a significant increase in bowel movements. In a systematic review and meta-analysis study evaluating the effect of foot reflexology in the management of functional constipation; It has been concluded that foot reflexology has a positive effect on stool frequency, stool consistency, difficult defecation, incomplete emptying of the intestines, abdominal pain and bloating. However, since the randomized controlled studies included in this study were studies with small sample groups, it was stated that larger studies were needed.
In addition to the effects in these studies, it is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply.
RESEARCH PROTOCOL The patients will be divided into 2 groups as experimental and control groups according to the predetermined randomization control list. In the first interview with the patients in the experimental group; patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Afterwards, the reflexology socks designed by the researcher for the patients; will be told to wear and walk 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday). Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again.
For the patients in the control group; In the first interview, patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Subsequently, patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again.
- Conditions
- Opioid Use, Constipation, Reflexology
- Being tested
- Reflexology socks+walking, Just walking
- Keywords
- Opioid induced Constipation, Reflexology
- Medical subject headings
- Constipation, Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology socks+walkingOther
Patients should wear reflexology socks; Wearing clothes and walking 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday)
Just walkingOther
Patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology socks+Walking | Experimental | In the first interview; patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Afterwards, the reflexology socks designed by the researcher for the patients; will be told to wear and walk 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday). Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 30th day of the application, the Constipation Quality of Life Scale will be administered to the patients again. Receives: Other: Reflexology socks+walking |
| Just walking | Other | In the first interview, patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Subsequently, patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 130th day of the application, the Constipation Quality of Life Scale will be administered to the patients again. Receives: Other: Just walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in defecation routine ( frequency, amount of stool etc.)
The daily defecation routine of the patients was assessed with the Daily Defecation Scale. With this chart, the amount of stool, stool consistency, straining during defecation, feeling of incomplete evacuation after defecation, and number of defecations are monitored weekly. With this form, patients recorded their defecation status for 5 weeks each time they defecated. Scores collected for each symptom of constipation are calculated by dividing the number of defecations in the same week.
Measured: Every day / for 5 weeks
The change in the severity of the symptoms of constipation
The changes in constipation-related symptoms were assessed with the Visual Comparison Scale.
Visual Comparison Scale: It is a 6-question scale that evaluates the severity of the symptoms of constipation (constipation severity, straining, feeling of incomplete evacuation, rectal fullness, rectal pain and gas) in the patient. The visual comparison scale consists of a horizontal line between 0-10.
Measured: Every day / for 5 weeks
The change in stool consistency and type.
At the time of defecation, stool consistency and type were assessed with the Bristol Stool Scale.This scale is used to evaluate stool shape and form in order to monitor changes in bowel functions. Stool shape is classified into 7 different categories. In this scale, which accepts that the stool form changes with the residence time of the stool in the colon; 1 and 2 type patients have Constipation, 3 and 4 types have normal stools and 5-7. type indicates that the patient has diarrhea.
Measured: At the time of defecation/ for 5 weeks
The change in quality of life due to constipation
The change in quality of life due to constipation was assessed with the Constipation Quality of Life Scale.
Constipation Quality of Life Scale: The item scores of this Likert-type scale range from 1 to 5. The subscales of this 28-item scale are "Anxiety/Anxiety" (11 items), "Physical Discomfort" (4 items), "Psychosocial Discomfort" (8 items), "Satisfaction" (5 items).
Measured: At baseline, at day 15 and at day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start30 Oct 2020
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda AKYUZ OZDEMIR, MsCN, Muğla Sıtkı Koçman University
- Investigators
- Ferda AKYÜZ ÖZDEMİR, Principal investigator, Mugla Sıtkı Koçman University Fethiye Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314335
- Sponsor's protocol ID
- FAKYUZOZDEMİR
- Status last verified
- Apr 2023
- First submitted
- 18 Mar 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology Socks On The Management of Opioid-Induced Constipation
- ClinicalTrials.gov ID
- NCT05314335
- Acronym / sponsor ID
- FAKYUZOZDEMİR
- Conditions
- Opioid Use, Constipation, Reflexology
- Keywords
- Opioid induced Constipation, Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Opioids are one of the most commonly used treatment approaches in the treatment of severe pain due to cancer and non-cancer causes. The most commonly reported side effect by patients related to opioid use is constipation. Opioid-related constipation, with an overall incidence of between 17% and 88%, requires a reduction in the treatment dose or drug rotation in some patients. It also makes it difficult for patients to comply with treatment. However, if the constipation due to opioid use is not managed properly and continues for a long time, many problems such as hemorrhoids and perforation, rectal pain and burning, intestinal rupture, anal fissure, diarrhea due to partial obstruction, urinary incontinence may develop.
It is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply.
The aim of this study is to examine whether reflexology stockings are an effective approach in reducing opioid-related constipation.
Detailed description
The basis of the physiopathological mechanism of constipation due to opioid use is the reducing effect on intestinal motility. There are opioid receptors called "mu" in the enteric nervous system. In patients using opioids, opioid agonists bind to these receptors. As a result of the binding of opioid agonists to the "mu" receptors, the release of excitatory and inhibitory neurotransmitters is inhibited and the coordinated rhythmic contractions required for bowel movements are reduced, as a result, peristaltic movements in the ileum and colon slow down and opioid-related intestinal dysfunction develops. With the prolonged stay of feces in the intestinal lumen, fluid absorption from the intestine increases and dry, hard stools are formed. Sphincter tone and non-impulsive contractions increase. As a result of all these effects, constipation develops.
In the management of constipation; In this study, both the effects of reflexology applied to the foot on the neuropeptide system and the effect of regulating electromagnetic transmissions were utilized. In a study conducted with the participation of children with cerebral palsy with constipation, it was reported that reflexology applied to the foot twice a week for 8 weeks had a positive effect on constipation. In a different study evaluating the effect of foot reflexology in patients with Multiple Sclerosis, it was reported that reflexology massage applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30-40 minutes once a week for 6 weeks reduced constipation. In a different study conducted with the participation of elderly patients, it was reported that foot reflexology applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30 minutes 3 times a week for 1 month resulted in a significant increase in bowel movements. In a systematic review and meta-analysis study evaluating the effect of foot reflexology in the management of functional constipation; It has been concluded that foot reflexology has a positive effect on stool frequency, stool consistency, difficult defecation, incomplete emptying of the intestines, abdominal pain and bloating. However, since the randomized controlled studies included in this study were studies with small sample groups, it was stated that larger studies were needed.
In addition to the effects in these studies, it is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply.
RESEARCH PROTOCOL The patients will be divided into 2 groups as experimental and control groups according to the predetermined randomization control list. In the first interview with the patients in the experimental group; patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Afterwards, the reflexology socks designed by the researcher for the patients; will be told to wear and walk 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday). Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again.
For the patients in the control group; In the first interview, patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Subsequently, patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflexology socks+Walking | Experimental | Other: Reflexology socks+walkingIn the first interview; patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Afterwards, the reflexology socks designed by the researcher for the patients; will be told to wear and walk 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday). Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 30th day of the application, the Constipation Quality of Life Scale will be administered to the patients again. |
| Just walking | Other | Other: Just walkingIn the first interview, patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Subsequently, patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 130th day of the application, the Constipation Quality of Life Scale will be administered to the patients again. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who are at least 18 years old ( ≥ 18 years old)
- Patients with a maximum age of 85 years (≤ 85 years old)
- Patients who volunteered to participate in the study
- Does not have any disability in communicating cognitively, mentally and verbally.
- Opioid treatment applied for approximately 2 weeks
Key exclusion criteria (4 listed)
- Having a complaint of peripheral neuropathy
- Being diagnosed with diabetes
- Having impaired skin integrity
- Having any deformity of flat feet or feet
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 |
|---|---|---|
| Reflexology socks+walkingPatients should wear reflexology socks; Wearing clothes and walking 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday) | Other | Reflexology socks+Walking |
| Just walkingPatients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. | Other | Just walking |
Primary outcome
The change in defecation routine ( frequency, amount of stool etc.)
Time frame: Every day / for 5 weeks
The daily defecation routine of the patients was assessed with the Daily Defecation Scale. With this chart, the amount of stool, stool consistency, straining during defecation, feeling of incomplete evacuation after defecation, and number of defecations are monitored weekly. With this form, patients recorded their defecation status for 5 weeks each time they defecated. Scores collected for each symptom of constipation are calculated by dividing the number of defecations in the same week.
The change in the severity of the symptoms of constipation
Time frame: Every day / for 5 weeks
The changes in constipation-related symptoms were assessed with the Visual Comparison Scale. Visual Comparison Scale: It is a 6-question scale that evaluates the severity of the symptoms of constipation (constipation severity, straining, feeling of incomplete evacuation, rectal fullness, rectal pain and gas) in the patient. The visual comparison scale consists of a horizontal line between 0-10.
The change in stool consistency and type.
Time frame: At the time of defecation/ for 5 weeks
At the time of defecation, stool consistency and type were assessed with the Bristol Stool Scale.This scale is used to evaluate stool shape and form in order to monitor changes in bowel functions. Stool shape is classified into 7 different categories. In this scale, which accepts that the stool form changes with the residence time of the stool in the colon; 1 and 2 type patients have Constipation, 3 and 4 types have normal stools and 5-7. type indicates that the patient has diarrhea.
The change in quality of life due to constipation
Time frame: At baseline, at day 15 and at day 30.
The change in quality of life due to constipation was assessed with the Constipation Quality of Life Scale. Constipation Quality of Life Scale: The item scores of this Likert-type scale range from 1 to 5. The subscales of this 28-item scale are "Anxiety/Anxiety" (11 items), "Physical Discomfort" (4 items), "Psychosocial Discomfort" (8 items), "Satisfaction" (5 items).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruitingPhase 1/2
Sublingual Dexmedetomidine for Treating Opioid Withdrawal
Opioid Use Disorder, Opioid Withdrawal
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
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.
Ferda AKYÜZ ÖZDEMİR principal investigator
Mugla Sıtkı Koçman University Fethiye Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology socks+walking and Just walking in people with Opioid Use and Constipation, run by Muğla Sıtkı Koçman 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 12 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in defecation routine ( frequency, amount of stool etc.) (time frame: Every day / for 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.