Parental Blinding in Clinical Trials of Osteopathy
A Study to Explore the Acceptability of Parental Blinding in Clinical Trials of Osteopathy With Excessively Crying Infants as Study Participants
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this research is to assess the acceptability of using a mobile folding screen for blinding parents of infant study participants in clinical trials of osteopathic interventions. The preliminary data of this acceptability study will inform future randomized controlled trials with infant participants where parental blinding is required. 30 excessively crying infants will be randomly allocated to 2 groups, one group receives osteopathic intervention, the other group does not receive treatment. All infants are treated (or not) behind a mobile folding screen, so that parents are not aware of group allocation. After a 'treatment' period of 20 min, the screen is removed, and parents are asked to fill in an acceptability and blinding success questionnaire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 29, 2015
July 1, 2015
5 months
July 28, 2015
July 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Blinding success and acceptability questionnaire (non-validated)
Parents are asked whether they found aspects of the treatment environment (intermediary, screen) acceptable or not, they are also asked which group they believed their child was placed in
up to 5 min
Study Arms (2)
No intervention
NO INTERVENTIONSubjects do not receive osteopathic care
Cranial osteopathic manipulative treatment
EXPERIMENTALSubjects receive individualised osteopathic treatment
Interventions
Eligibility Criteria
You may qualify if:
- Infants aged up to four months, crying for more than three hours per day, some of the crying is in-consolable; parents have signed a consent form to take part in the study
You may not qualify if:
- Infants who are not safe to treat as a result of the osteopathic assessment procedure, infants where no inconsolable crying is reported by parent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European School of Osteopathy
Maidstone, Kent, ME14 3DZ, United Kingdom
Related Publications (1)
Miller JE, Newell D, Bolton JE. Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial. J Manipulative Physiol Ther. 2012 Oct;35(8):600-7. doi: 10.1016/j.jmpt.2012.09.010.
PMID: 23158465BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2015
First Posted
July 29, 2015
Study Start
June 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
July 29, 2015
Record last verified: 2015-07