None listed
Conditions
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.
Interventions
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 trai
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.
Sponsors
University College of Osteopathy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Days to 70 Days
Healthy volunteers
Yes
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
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
Outcome results
None listed