Reflexology Socks and Opioid-induced Constipation
Condition: Opioid Use; Constipation; Reflexology
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional

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.
    

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.
    

Intervention name(s): Reflexology socks+walking; Just walking
Intervention type(s): Other; Other
Intervention description(s): 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); 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Opioid induced Constipation; Reflexology