To Evaluate the Effects of Heating Device (Electronic Moxibustion) in Patients With Intradialytic Hypotension
Condition: Hemodialysis-Induced Symptom; Intra-dialytic Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of heating device among otherwise stable
      patients with intradialytic hypotension
    

Detailed description: 
      Intradialytic hypotension (IDH) is a common complication during hemodialysis (HD) which
      accounts up to 5 to 30 percent of all dialysis treatment and is associated with increased
      morbidity and mortality. The etiology of IDH is multifactorial, but intravascular volume
      depletion, autonomic neuropathy, and decreased cardiac reserve were the main factors. Several
      approaches were utilized to prevent IDH including adaptation of dialysis prescriptions,
      lengthening in dialysis time, avoiding food intake during dialysis, as well as limiting
      interdialytic sodium intake and administration of vasoconstrictor agents. However, it remains
      necessary to seek novel effective and safe inventions for IDH. To date, no studies have been
      done to evaluate the effectiveness of acupuncture and traditional moxibustion during HD for
      safety reasons (eg: risk of bleeding, burns and unpleasant smell). Therefore, the heating
      device appears to be a non-invasive and safe method for treating IDH. The investigators
      conduct a clinical trial using infrared heating devices without direct contact to the skin on
      low temperatures (56±8℃) in treating patients with IDH. 30 eligible participants diagnosed
      with IDH will be enrolled and divided into Group 1 and Group 2. Treatment 1# will be regular
      dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week
      plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during
      dialysis, also for 4 weeks. For Group 1, each subject will receive Treatment 1# first, for
      Group 2, Treatment 2# will be received first. Then, it takes 2-week washout period with
      regular dialysis 3 times per week and make Group 1 and Group 2 crossover. Outcomes will
      include blood pressure changes, nursing intervention frequencies, IDH frequencies, the degree
      of cold intolerance, the degree of fatigue after dialysis and recovery time from fatigue
      after dialysis, the percentage of target ultrafiltration achieved and blood biochemistry.
      Data will be collected at the beginning of the study (baseline), end of Treatment 1 # , and
      end of Treatment 2#. Subjective questionnaires will be collected before and after each
      treatment period. The difference of evaluation scores between baseline and post-treatment
      will be analyzed using generalized linear mixed model. A value of P < 0.05 will be regarded
      as statistically significant for the above statistical analyses.
    

Intervention name(s): "HEALTHY BOX" Powered heating pad (electronic moxibustion)
Intervention type(s): Device
Intervention description(s): Using heating pad (electronic moxibustion) with insulating materials on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 30 eligible participants diagnosed with IDH will be enrolled and divided randomly and equally into Group 1 and Group 2 . Treatment 1# will be regular dialysis 3 times per week for 4 weeks. Treatment 2# will be regular dialysis 3 times per week plus "HEALTHY BOX" Powered heating pad on acupoint CV4 at the abdomen for 1 hour during dialysis, also for 4 weeks. For Group 1, each subject will receive Treatment 1# first, for Group 2, Treatment 2# will be received first. Then, a 2-week washout period with regular dialysis 3 times per week will be carried out. Group 1 will then receive Treatment 2# and Group 2 will then receive Treatment 1#. Subjective questionnaires will be done before and after each Treatment period.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: hemodialysis; Intra-dialytic Hypotension; heating device; electronic moxibustion