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Trial registered on ANZCTR


Registration number
ACTRN12620000047998
Ethics application status
Approved
Date submitted
13/12/2019
Date registered
22/01/2020
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Crying Unsettled and disTressed Infants: Effectiveness Study of osteopathic care
Scientific title
A pragmatic randomised controlled trial to test the effectiveness and cost of osteopathic light touch manual therapy on crying time in healthy infants who are unduly distressed, unsettled and crying excessively.
Secondary ID [1] 300096 0
None
Universal Trial Number (UTN)
Trial acronym
CUTIES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infantile colic 315623 0
Condition category
Condition code
Alternative and Complementary Medicine 313917 313917 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 313953 313953 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Light touch osteopathic care and advice.
The intervention arm of the trial involves light osteopathic touch intended to target specific areas of the baby's body according to the baby's needs, to reduce tension in the soft tissues and promote circulation. This arm will be referred to as the Targeted Tension Release (TTR) arm. An osteopaths hands are placed gently on the infant to palpate and deliver targeted light touch therapy for 10-20 minutes. This is usual osteopathic care delivered by a trained, registered and statutory regulated osteopathic practitioner, with a minimum of one years post graduate experience who sees on average one infant per week. One to four treatments can be administered depending on the needs of the infant and the parent(s) over a 14 day period.
Private practice clinics will be used to recruit participants.
Advice and guidance will be in accordance with the National Institute of Health Research and Excellence, UK (www.nice.org.uk Clinical Knowledge Summary Infant Colic 2017 and Postnatal care: Routine postnatal care of women and their babies (NICE Guideline, 2015). Advice and guidance will be given verbally as appropriate during the consultations which will be dependent on the needs of the parent and infant.
Trial osteopaths will receive specific training over one day before they are evaluated and included in the study. A random sample of osteopaths will be observed to check fidelity of intervention delivery and 50% of participant records will be reviewed.
Intervention code [1] 316369 0
Treatment: Other
Comparator / control treatment
Non specific light touch and advice
The comparator arm will be called the Generic Tension Release (GTR) arm, it will involve light touch alone which is not targeted or directed at specific areas of the baby's soft tissues. An osteopaths hands are placed gently on the infant's cranium, thorax or abdomen to deliver light non-therapeutic intent touch for 10-20 minutes. The areas touched and the length of time the osteopath spends on the area will be at the discretion of the osteopath, This will be delivered by a trained, registered and statutory regulated osteopathic practitioner, with a minimum of one years post graduate experience who sees on average one infant per week. One to four treatments can be administered depending on the needs of the infant and the parent(s) over a 14 day period.
Private practice clinics will be used to recruit participants.
Advice and guidance will be in accordance with the National Institute of Health Research and Excellence, UK (www.nice.org.uk Clinical Knowledge Summary Infant Colic 2017 and Postnatal care: Routine postnatal care of women and their babies (NICE Guideline, 2015). Advice and guidance will be given verbally as appropriate during the consultations which will be dependent on the needs of the parent and infant.
Trial osteopaths will receive specific training over one day before they are evaluated and included in the study. A random sample of osteopaths will be observed to check fidelity of intervention delivery and 50% of participant records will be reviewed.
Control group
Placebo

Outcomes
Primary outcome [1] 322304 0
Primary outcome: Mean 24 hour crying time - determined by daily crying time recorded hourly by parents using a crying diary.
Timepoint [1] 322304 0
Mean crying time per 24 hours over 14 days post randomisation
Secondary outcome [1] 378016 0
Parenting confidence as measured by the Karitane Parents Confidence Questionnaire (Crncec et al 2008), This is a parent reported confidence scale over 15 confidence domains.
Timepoint [1] 378016 0
14 days post randomisation
Secondary outcome [2] 378017 0
Adverse events will be recorded as per Medical Health Research Authority guidance. Adverse events can range from mild (for example, in this study, slight transient increases in crying time, fussing and possetting) to moderate (increased and more persistent crying time, fussing and possetting and any other moderate unexpected unwanted reaction and or other care sought) to major or severe events resulting in unexpected hospital admission and or death, which are not expected with gentle hands non invasive light touch in healthy and thriving infants,
Timepoint [2] 378017 0
During the study period of 14 days post randomisation
Secondary outcome [3] 378018 0
Satisfaction with care using a 5 item Likert scale
Timepoint [3] 378018 0
14 days post randomisation
Secondary outcome [4] 378019 0
Experience of care using a 5 item Likert scale
Timepoint [4] 378019 0
14 days post randomisation
Secondary outcome [5] 378711 0
Global change using a parent reported 5 item Likert scale
Timepoint [5] 378711 0
14 days post randomisation

Eligibility
Key inclusion criteria
Excessive crying and fussing and difficult to console for 3 hours or more a day for 3 days or more a week for 1 week or more.
Infants must be healthy and thriving
Parent informed and valid consent for their infant
Minimum age
7 Days
Maximum age
70 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Other health conditions requiring medical care
Parent does not have capacity to consent
Parent not fluent enough in English to comprehend trial literature and questionnaires
Parent is under 18 years of age

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed, Randomisation is via real time online software after submission of baseline questionnaire, infant health screening and consent.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be 1:1. Block randomisation with variable block size of 4 and 6 generated by CastorEDC.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The parents are blinded to the interventions their infant receives. They are with their infants at all times and are unaware whether the infant is touched with osteopathic light touch or non specific light touch
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We estimate the average daily crying time over the two-week follow-up period to be of 120 minutes with a SD of 46 minutes. To detect a minimum of 30 minutes additional reduction in crying time between the intervention and control group with 90% power and a two-sided 5% significance level we would need 48 infants in each arm of the trial. If we allow for a 15% drop out we would need to randomise 112 infants, 56 in each arm of the trial.
All analysis will be intent-to-treat except for a secondary per protocol analysis on the primary outcome. All P values will be two sided, and the significance level is set at 5%..
We will analyse the primary outcome of crying time (i.e. summary measure of mean crying time over time in minutes) using a multilevel mixed-effects generalized linear model (GLM) adjusting for lack of independence at a site and at a practitioner level.. Crying time will be entered as the dependent variable and group allocation as the explanatory variable. The hierarchical multilevel datasets is assumed with normally distributed random effects. Likelihood ratio test will be used to test for clustering effects. Results will be reported as between group difference in crying time in hours with a 95% confidence interval and a joint p-value for differences over all time points. Statistical inference for significance of effects of the intervention will be calculated using Wald Chi2 test..

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment outside Australia
Country [1] 22186 0
United Kingdom
State/province [1] 22186 0
London and Kent

Funding & Sponsors
Funding source category [1] 304541 0
Charities/Societies/Foundations
Name [1] 304541 0
National Council for Osteoapthic Research UK
Address [1] 304541 0
Institute of Population Health Sciences. Queen Mary University of London. 58 Turner St, London E1 2AD
Country [1] 304541 0
United Kingdom
Primary sponsor type
University
Name
University College of Osteopathy
Address
275 Borough High St, London. UK SE1 1JE
Country
United Kingdom
Secondary sponsor category [1] 304812 0
None
Name [1] 304812 0
Address [1] 304812 0
Country [1] 304812 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304969 0
London-Surrey National Health Service Research Ethics Committee: IRAS # 268925
Ethics committee address [1] 304969 0
University of Surrey, Stag Hill, Guildford, UK. GU2 7XH
Ethics committee country [1] 304969 0
United Kingdom
Date submitted for ethics approval [1] 304969 0
01/10/2019
Approval date [1] 304969 0
09/11/2019
Ethics approval number [1] 304969 0
19/LO/1620
Ethics committee name [2] 304998 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [2] 304998 0
Southern Cross University
PO Box 157
Lismore NSW 2480
Ethics committee country [2] 304998 0
Australia
Date submitted for ethics approval [2] 304998 0
25/11/2019
Approval date [2] 304998 0
12/12/2019
Ethics approval number [2] 304998 0
2019/569

Summary
Brief summary
A randomised controlled trial to evaluate whether osteopathic light touch manual therapy care has an impact on reducing crying time in infants (under 10 weeks old) with colic. The comparator arm is non-specific light touch. We will need to randomise 112 parent(s)/carers and their infants. Parents will be blinded to whether their infant receives the usual osteopathic therapy care or not.
This study will provide information about the clinical and social relevance of osteopathic care for excessively crying, unsettled and distressed infants and their parents.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98806 0
Prof Dawn Carnes
Address 98806 0
University College of Osteopathy
275 Borough High St
London SE1 1JE
Country 98806 0
United Kingdom
Phone 98806 0
+44 2070895333
Fax 98806 0
Email 98806 0
dawn.carnes@uco.ac.uk
Contact person for public queries
Name 98807 0
Prof Dawn Carnes
Address 98807 0
University College of Osteopathy
275 Borough High St
London SE1 1JE
Country 98807 0
United Kingdom
Phone 98807 0
+44 2070895333
Fax 98807 0
Email 98807 0
dawn.carnes@uco.ac.uk
Contact person for scientific queries
Name 98808 0
Prof Dawn Carnes
Address 98808 0
University College of Osteopathy
275 Borough High St
London SE1 1JE
Country 98808 0
United Kingdom
Phone 98808 0
+44 2070895333
Fax 98808 0
Email 98808 0
dawn.carnes@uco.ac.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised final primary and secondary outcomes
When will data be available (start and end dates)?
The end date is yet to be determined but we expect within 2 years after publication of main trial paper.
Available to whom?
Those with a clear research question and legitimate research reasons
Available for what types of analyses?
Pre specified only
How or where can data be obtained?
The Prinicipal Investigator, Prof. Dawn Carnes, University College of Osteopathy, 275 Borough High St, London SE1 1JE. dawn.carnes@uco.ac.uk
What supporting documents are/will be available?
No other documents available
Summary results
No Results