NCT05799677

Brief Summary

To test the influence of reflexology on bronchiolitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

March 22, 2023

Last Update Submit

April 7, 2023

Conditions

Keywords

BronchiolitisReflexology

Outcome Measures

Primary Outcomes (2)

  • Hospitalization period

    The time from admission to discharge (days)

    1-14 days

  • Oxygen therapy period

    Number of days of oxygen treatment

    1-14 Days

Study Arms (2)

Reflexology

EXPERIMENTAL

Additive treatment with reflexology

Other: Reflexology

Control

NO INTERVENTION

No treatment with reflexology

Interventions

Additive reflexology treatment

Reflexology

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All children admitted due to bronchiolitis

You may not qualify if:

  • Children whose parents refused participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

Related Publications (6)

  • 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.

    PMID: 22087616BACKGROUND
  • 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.

    PMID: 34818220BACKGROUND
  • 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.

    PMID: 35599503BACKGROUND
  • 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.

    PMID: 33962511BACKGROUND
  • 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.

    PMID: 26833493BACKGROUND
  • 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.

    PMID: 1731571BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparing the extent of bronchiolitis between reflexology additive treatment to no reflexology treatment.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 5, 2023

Study Start

January 1, 2023

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations