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Reflexology Socks and Opioid-induced Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05314335
Recruitment Status : Active, not recruiting
First Posted : April 6, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Ferda AKYUZ OZDEMIR, MsCN, Muğla Sıtkı Koçman University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Opioid Use Constipation Reflexology Other: Reflexology socks+walking Other: Just walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Reflexology Socks On The Management of Opioid-Induced Constipation
Actual Study Start Date : October 30, 2020
Estimated Primary Completion Date : July 24, 2022
Estimated Study Completion Date : July 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reflexology socks+Walking
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.
Other: Reflexology socks+walking
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 walking
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.
Other: Just walking
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having a complaint of peripheral neuropathy
  • Being diagnosed with diabetes
  • Having impaired skin integrity
  • Having any deformity of flat feet or feet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05314335


Locations
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Turkey
Mugla Sitki Kocman University
Fethiye, Muğla, Turkey
Sponsors and Collaborators
Muğla Sıtkı Koçman University
Investigators
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Principal Investigator: Ferda AKYÜZ ÖZDEMİR Mugla Sıtkı Koçman University Fethiye Faculty of Health Sciences
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Responsible Party: Ferda AKYUZ OZDEMIR, MsCN, Research Assistant, Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier: NCT05314335    
Other Study ID Numbers: FAKYUZOZDEMİR
First Posted: April 6, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ferda AKYUZ OZDEMIR, MsCN, Muğla Sıtkı Koçman University:
Opioid induced Constipation
Reflexology
Additional relevant MeSH terms:
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Constipation
Opioid-Induced Constipation
Signs and Symptoms, Digestive
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders