Back to resultsThe Effect of Reflexology in Patients With Viral Bronchiolitis
Primary Purpose
Bronchiolitis; Chemical, Reflexology
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Reflexology
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis; Chemical focused on measuring Bronchiolitis, Reflexology
Eligibility Criteria
Inclusion Criteria: All children admitted due to bronchiolitis Exclusion Criteria: Children whose parents refused participation
Sites / Locations
- Hillel Yaffe medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Reflexology
Control
Arm Description
Additive treatment with reflexology
No treatment with reflexology
Outcomes
Primary Outcome Measures
Hospitalization period
The time from admission to discharge (days)
Oxygen therapy period
Number of days of oxygen treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05799677
First Posted
March 22, 2023
Last Updated
April 7, 2023
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05799677
Brief Title
The Effect of Reflexology in Patients With Viral Bronchiolitis
Official Title
The Effect of Reflexology in Patients With Viral Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hillel Yaffe Medical Center
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
To test the influence of reflexology on bronchiolitis.
Detailed Description
Reflexology has been used in different respiratory tract infections on pulmonary function tests in patients with asthma, with some success. It has also been tested in newborns with respiratory distress syndrome, where it has decreased respiratory rate. Whole body massage was found to be helpful in newborns with opioid withdrawal syndrome. It has been shown to be a safe treatment and well tolerated even among very young infants.
Therefore, the investigators decided to evaluate effect of reflexology treatment in patients with viral bronchiolitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis; Chemical, Reflexology
Keywords
Bronchiolitis, Reflexology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing the extent of bronchiolitis between reflexology additive treatment to no reflexology treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reflexology
Arm Type
Experimental
Arm Description
Additive treatment with reflexology
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment with reflexology
Intervention Type
Other
Intervention Name(s)
Reflexology
Intervention Description
Additive reflexology treatment
Primary Outcome Measure Information:
Title
Hospitalization period
Description
The time from admission to discharge (days)
Time Frame
1-14 days
Title
Oxygen therapy period
Description
Number of days of oxygen treatment
Time Frame
1-14 Days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children admitted due to bronchiolitis
Exclusion Criteria:
Children whose parents refused participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erez Nadir, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe medical center
City
H̱adera
State/Province
Hadera
ZIP/Postal Code
38100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22087616
Citation
Fattah MA, Hamdy B. Pulmonary functions of children with asthma improve following massage therapy. J Altern Complement Med. 2011 Nov;17(11):1065-8. doi: 10.1089/acm.2010.0758.
Results Reference
background
PubMed Identifier
34818220
Citation
Miralizadeh A, Peyman A, Jamali Soltani N, Ashktorab T. Comparison of the Effect of Foot and Palm Reflexology Massage on Respiratory Distress Syndrome in Premature Infants under Noninvasive Ventilation. Complement Med Res. 2022;29(2):100-108. doi: 10.1159/000517982. Epub 2021 Oct 29.
Results Reference
background
PubMed Identifier
35599503
Citation
Rana D, Garde K, Elabiad MT, Pourcyrous M. Whole body massage for newborns: A report on non-invasive methodology for neonatal opioid withdrawal syndrome. J Neonatal Perinatal Med. 2022;15(3):559-565. doi: 10.3233/NPM-220989.
Results Reference
background
PubMed Identifier
33962511
Citation
Jones LM, Regan C, Wolf K, Bryant J, Rakowsky A, Pe M, Snyder DA. Effect of osteopathic manipulative treatment on pulmonary function testing in children with asthma. J Osteopath Med. 2021 May 7;121(6):589-596. doi: 10.1515/jom-2020-0040.
Results Reference
background
PubMed Identifier
26833493
Citation
Roque i Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2016 Feb 1;2(2):CD004873. doi: 10.1002/14651858.CD004873.pub5.
Results Reference
background
PubMed Identifier
1731571
Citation
Wang EE, Milner RA, Navas L, Maj H. Observer agreement for respiratory signs and oximetry in infants hospitalized with lower respiratory infections. Am Rev Respir Dis. 1992 Jan;145(1):106-9. doi: 10.1164/ajrccm/145.1.106.
Results Reference
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The Effect of Reflexology in Patients With Viral Bronchiolitis
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