Reflexology Socks and Opioid-induced Constipation

NCT05314335 | Completed

• 1 other identifier: FAKYUZOZDEMİR
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Constipation; Reflexology

Keywords

Opioid induced Constipation; Reflexology

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  At baseline, at day 15 and at day 30.

Study Arms (2)

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.

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.

Other: Just walking

Interventions

Reflexology socks+walking OTHER

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)

Reflexology socks+Walking

Just walking OTHER

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.

Just walking

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sitki Kocman University

Fethiye, Muğla, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation; Opioid-Induced 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

Study Officials

• Ferda AKYÜZ ÖZDEMİR

  Mugla Sıtkı Koçman University Fethiye Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

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: Research Assistant

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 6, 2022
• Study Start: October 30, 2020
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)