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Parental Blinding in Clinical Trials of Osteopathy

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ClinicalTrials.gov Identifier: NCT02511171
Recruitment Status : Unknown
Verified July 2015 by European School of Osteopathy.
Recruitment status was:  Recruiting
First Posted : July 29, 2015
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
European School of Osteopathy

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.

Condition or disease Intervention/treatment Phase
Infantile Colic Other: Cranial osteopathic manipulative therapy Not Applicable

Detailed Description:

Parents who take part in the research will arrive at their scheduled appointment. If parents have not brought their signed consent form, they will be asked to sign it in clinic. This consent form also will contain questions about infant and parent demographics as well as socio-demographic background details, which the parent is asked to fill in. Parents will be guided into a separate treatment room, which contains a treatment table behind a screen. A qualified osteopathic practitioner will take the case history for each infant who then receives a physical assessment. After that, the parent will have to give consent for the infant to be further involved in the study and to be treated. This procedure will be done without the screen, so that the parent can see what is going on. Then the infant is placed behind the screen on the treatment couch. The osteopath will be informed by the Research Assistant whether the infant is allocated (via random allocation list) to receiving either no intervention or OMT for 20 min. For infants in the OMT group, the osteopathic practitioner will carry out the treatment procedure, and the Research Assistant will act as an intermediary. Infants in the 'no intervention' group will just lie on the couch, without being touched by the osteopath.

At all times, the screen is placed between the parent and their infant on the treatment couch, so that the parent will not be able to see their infant. However, the intermediary is placed in a way so that the parent can see and communicate with them, and the intermediary can observe what is happening behind the screen with the infant. The osteopathic practitioner will be present at all times in both groups, to safeguard the infant from rolling off the couch in case the infant does not receive any intervention. In addition, if the infant starts crying, the osteopathic practitioner will try to calm the infant down (for infants in the OMT group the osteopath will use toys and touch, in the 'no intervention' group toys only will be used, no touch), but if necessary will ask the parent to come round the screen and help in calming their infant down. If this is the case, the osteopathic practitioner stops the treatment, if the infant is placed in the OMT group, and waits until the infant is calmed down so that the parent can go back behind the screen. This procedure will be repeated until 20 min of the treatment period are over. The same procedure applies for the 'no intervention group', except that the osteopath will not touch the infant, rather tries to calm it down with toys or eventually will call the parent in to do the calming. After the 20mins of 'treatment period', parents of infants in both groups are required to fill in the blinding success and acceptability questionnaire.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: A Study to Explore the Acceptability of Parental Blinding in Clinical Trials of Osteopathy With Excessively Crying Infants as Study Participants
Study Start Date : June 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
No Intervention: No intervention
Subjects do not receive osteopathic care
Experimental: Cranial osteopathic manipulative treatment
Subjects receive individualised osteopathic treatment
Other: Cranial osteopathic manipulative therapy
Other Name: Cranial osteopathy




Primary Outcome Measures :
  1. Blinding success and acceptability questionnaire (non-validated) [ Time Frame: up to 5 min ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Infants who are not safe to treat as a result of the osteopathic assessment procedure, infants where no inconsolable crying is reported by parent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511171


Contacts
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Contact: Anne Jakel, DPhil annejakel@eso.ac.uk

Locations
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United Kingdom
European School of Osteopathy Recruiting
Maidstone, Kent, United Kingdom, ME14 3DZ
Contact: Jakel       annejakel@eso.ac.uk   
Principal Investigator: Anne Jakel, BSc (Hons) Ost, DPhil         
Sponsors and Collaborators
European School of Osteopathy

Publications:
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Responsible Party: European School of Osteopathy
ClinicalTrials.gov Identifier: NCT02511171    
Other Study ID Numbers: ESO-002-Pilot1
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases