The Effect of Reflexology in Patients With Viral Bronchio... | NCT05799677

Studies
The Effect of Reflexology in Patients With Viral Bronchiolitis

NCT05799677

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Apr 11, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Bronchiolitis; Chemical
Reflexology

Interventions

Reflexology

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Mar 22, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2023

Last Update Posted Date

Apr 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erez Nadir, MD, Principal Investigator, Hillel Yaffe Medical CenterPrincipal Investigator

Lead Sponsor

Hillel Yaffe Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reflexology	Experimental	Additive treatment with reflexology	Other: Reflexology
Control	No Intervention	No treatment with reflexology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reflexology	Other	Additive reflexology treatment	Reflexology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization period	The time from admission to discharge (days)	1-14 days
Oxygen therapy period	Number of days of oxygen treatment	1-14 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All children admitted due to bronchiolitis

Exclusion Criteria:

Children whose parents refused participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erez Nadir, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe medical center		Hadera	Hadera	38100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22087616	Background	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.
34818220	Background	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.

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation