Bronchiolitis; ChemicalNCT05799677
The Effect of Reflexology in Patients With Viral Bronchiolitis
A study testing Reflexology in people with Bronchiolitis; Chemical and Reflexology, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
To test the influence of reflexology on bronchiolitis. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bronchiolitis; Chemical, Reflexology
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2023to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children admitted due to bronchiolitis
Who cannot join
- Children whose parents refused participation
Trial locations and contacts
1 site in 1 country.
About this study
To test the influence of reflexology on bronchiolitis.
Read the 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.
- Conditions
- Bronchiolitis; Chemical, Reflexology
- Being tested
- Reflexology
- Keywords
- Bronchiolitis, Reflexology
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
Additive reflexology treatment
| Study group | Role | What they receive |
|---|---|---|
| Reflexology | Experimental | Additive treatment with reflexology Receives: Other: Reflexology |
| Control | No intervention | No treatment with reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization period
The time from admission to discharge (days)
Measured: 1-14 days
Oxygen therapy period
Number of days of oxygen treatment
Measured: 1-14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis; ChemicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparing the extent of bronchiolitis between reflexology additive treatment to no reflexology treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799677
- Sponsor's protocol ID
- 0135-22-HYMC-IL
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22087616Miralizadeh 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.
PubMed 34818220Rana 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.
PubMed 35599503Jones 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.
PubMed 33962511Roque 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.
PubMed 26833493Wang 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.
PubMed 1731571
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology in Patients With Viral Bronchiolitis
- ClinicalTrials.gov ID
- NCT05799677
- Acronym / sponsor ID
- 0135-22-HYMC-IL
- Conditions
- Bronchiolitis; Chemical, Reflexology
- Keywords
- Bronchiolitis, Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparing the extent of bronchiolitis between reflexology additive treatment to no reflexology treatment.
| Arm | Type | Receives |
|---|---|---|
| Reflexology | Experimental | Other: ReflexologyAdditive treatment with reflexology |
| Control | No intervention | –No treatment with reflexology |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children admitted due to bronchiolitis
Key exclusion criteria (1 listed)
- Children whose parents refused participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReflexologyAdditive reflexology treatment | Other | Reflexology |
Primary outcome
Hospitalization period
Time frame: 1-14 days
The time from admission to discharge (days)
Oxygen therapy period
Time frame: 1-14 Days
Number of days of oxygen treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 22087616Fattah 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.
- Background: PubMed 34818220Miralizadeh 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.
- Background: PubMed 35599503Rana 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.
- Background: PubMed 33962511Jones 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.
- Background: PubMed 26833493Roque 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.
- Background: PubMed 1731571Wang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erez Nadir, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Bronchiolitis; Chemical and Reflexology, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization period (time frame: 1-14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799677, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.