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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]

None

Universal Trial Number (UTN)

Trial acronym

CUTIES

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Infantile colic

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Reproductive Health and Childbirth

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]

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]

Primary outcome: Mean 24 hour crying time - determined by daily crying time recorded hourly by parents using a crying diary.

Timepoint [1]

Mean crying time per 24 hours over 14 days post randomisation

Secondary outcome [1]

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]

14 days post randomisation

Secondary outcome [2]

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]

During the study period of 14 days post randomisation

Secondary outcome [3]

Satisfaction with care using a 5 item Likert scale

Timepoint [3]

14 days post randomisation

Secondary outcome [4]

Experience of care using a 5 item Likert scale

Timepoint [4]

14 days post randomisation

Secondary outcome [5]

Global change using a parent reported 5 item Likert scale

Timepoint [5]

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

Sex

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

1/02/2020

Actual

Date of last participant enrolment

Anticipated

29/01/2021

Actual

Date of last data collection

Anticipated

12/03/2021

Actual

Sample size

Target

112

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,VIC

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

London and Kent

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Council for Osteoapthic Research UK

Address [1]

Institute of Population Health Sciences. Queen Mary University of London. 58 Turner St, London E1 2AD

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

London-Surrey National Health Service Research Ethics Committee: IRAS # 268925

Ethics committee address [1]

University of Surrey, Stag Hill, Guildford, UK.  GU2 7XH

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

01/10/2019

Approval date [1]

09/11/2019

Ethics approval number [1]

19/LO/1620

Ethics committee name [2]

Southern Cross University Human Research Ethics Committee

Ethics committee address [2]

Southern Cross University
PO Box 157
Lismore  NSW 2480

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

25/11/2019

Approval date [2]

12/12/2019

Ethics approval number [2]

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

Prof Dawn Carnes

Address

University College of Osteopathy
275 Borough High St
London SE1 1JE

Country

United Kingdom

Phone

+44 2070895333

Fax

dawn.carnes@uco.ac.uk

Contact person for public queries

Name

Dawn Carnes

Address

University College of Osteopathy
275 Borough High St
London SE1 1JE

Country

United Kingdom

Phone

+44 2070895333

Fax

dawn.carnes@uco.ac.uk

Contact person for scientific queries

Name

Dawn Carnes

Address

University College of Osteopathy
275 Borough High St
London SE1 1JE

Country

United Kingdom

Phone

+44 2070895333

Fax

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Crying Unsettled and disTressed Infants Effectiveness Study of osteopathic care (CUTIES trial): Pragmatic randomised superiority trial protocol.	2020	https://dx.doi.org/10.1016/j.ijosm.2020.08.001

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically