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Parental Blinding in Clinical Trials of Osteopathy

NCT02511171 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-07-29

No results posted yet for this study

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.

Conditions

  • Infantile Colic

Interventions

OTHER

Cranial osteopathic manipulative therapy

Sponsors & Collaborators

  • European School of Osteopathy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02511171 on ClinicalTrials.gov