Heat Wrap for Renal Colic
Primary Purpose
Renal Colic
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Heat Wrap
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic focused on measuring Heat wrap
Eligibility Criteria
Inclusion Criteria:
- Patients with renal colic
Exclusion Criteria:
- Pregnants
- Known allergies to heat tapes
Sites / Locations
- Murat GülRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Heat Wrap Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Pain Intensity Scale
Self reported pain intensity (VAS 0-10) after applying heat wrap. Each item is scored between 0-10. While 0 shos no pain, 10 is the greatest pain the patient has experienced
Secondary Outcome Measures
Full Information
NCT ID
NCT03790514
First Posted
December 28, 2018
Last Updated
December 28, 2018
Sponsor
Aksaray University Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03790514
Brief Title
Heat Wrap for Renal Colic
Official Title
Alternative Therapy for Pain Management in Patients With Renal Colic: Heat Wrap
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
March 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac, kotorolac, piroxicam) opioids (petidine, tramadol, fentanyl), paracetamol and topical agents (EMLA, diclofenal gel), have been shown to be effective in the treatment of renal colic . NSAIDs are commonly used to treat renal colic, but they can reduce renal blood flow and cause kidney damage. In addition, there are limitations in use in cases such as gastrointerstinal ulcers, hepatic insufficiency and chronic obstructive pulmonary disease. Gastrointestinal complications (ulcers, reflux, etc.) may cause hypersensitivity reactions (allergy) and coagulation disorders. On the other hand, opioids may cause nausea, vomiting, hypotension, sedation, dizziness and even respiratory depression. In addition to these pharmacological agents, stair-stroke, Turkish bath, blanket or hot water bag and local warming are now used in the treatment of renal colic in traditional methods.
Heat Wrap is an effective, natural solution designed to remove muscle pain with the help of heat and used regularly by physical therapists. The heat wrap is activated by air contact within a few minutes after its removal from its sheet and does not contain any drugs. It contains heat from the active iron particles in contact with air. After a few minutes of application, it begins to spread the natural, long-term (8 hours) heat by targeting the source of the pain. The patient satisfaction is high because it is odorless and thin.
In the literature, considering the success of heat therapy in patients with renal colic (bath entrance, electric blanket heating) in this study we have aimed to evaluate the efficacy of alternative treatment with pain-relieving alternative treatments with little potential for side effects and to see its applicability in daily treatment plans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
Heat wrap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heat Wrap Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Heat Wrap
Intervention Description
Commercially heat tapes ( without drugs) will be applied to patients.
Primary Outcome Measure Information:
Title
Pain Intensity Scale
Description
Self reported pain intensity (VAS 0-10) after applying heat wrap. Each item is scored between 0-10. While 0 shos no pain, 10 is the greatest pain the patient has experienced
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Patients with renal colic
Exclusion Criteria:
Pregnants
Known allergies to heat tapes
Facility Information:
Facility Name
Murat Gül
City
Aksaray
ZIP/Postal Code
68000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Gül
Phone
905056316913
Email
drgulacademics@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Heat Wrap for Renal Colic
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