Infantile ColicNCT02511171
Parental Blinding in Clinical Trials of Osteopathy
A study testing Cranial osteopathic manipulative therapy in people with Infantile Colic, run by European School of Osteopathy at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Cranial osteopathic manipulative therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Infants who are not safe to treat as a result of the osteopathic assessment procedure, infants where no inconsolable crying is reported by parent
Trial locations and contacts
1 site in 1 country.
Anne Jakel, DPhil contact
United Kingdom1 site, 1 recruiting
- Recruiting
European School of Osteopathy
Maidstone, Kent, ME14 3DZ
Jakel, annejakel@eso.ac.uk
Anne Jakel, BSc (Hons) Ost, DPhil
About this study
Official title: A Study to Explore the Acceptability of Parental Blinding in Clinical Trials of Osteopathy With Excessively Crying Infants as Study Participants
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.
Read the 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.
- Conditions
- Infantile Colic
- Being tested
- Cranial osteopathic manipulative therapy
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial osteopathic manipulative therapyOther
Also called Cranial osteopathy
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Subjects do not receive osteopathic care |
| Cranial osteopathic manipulative treatment | Experimental | Subjects receive individualised osteopathic treatment Receives: Other: Cranial osteopathic manipulative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinding success and acceptability questionnaire (non-validated)
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
Measured: up to 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European School of Osteopathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511171
- Sponsor's protocol ID
- ESO-002-Pilot1
- Status last verified
- Jul 2015
- First submitted
- 28 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
Publications
Miller JE, Newell D, Bolton JE. Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial. J Manipulative Physiol Ther. 2012 Oct;35(8):600-7. doi: 10.1016/j.jmpt.2012.09.010.
PubMed 23158465
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Explore the Acceptability of Parental Blinding in Clinical Trials of Osteopathy With Excessively Crying Infants as Study Participants
- ClinicalTrials.gov ID
- NCT02511171
- Acronym / sponsor ID
- ESO-002-Pilot1
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- European School of OsteopathyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Subjects do not receive osteopathic care |
| Cranial osteopathic manipulative treatment | Experimental | Other: Cranial osteopathic manipulative therapySubjects receive individualised osteopathic treatment |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Infants who are not safe to treat as a result of the osteopathic assessment procedure, infants where no inconsolable crying is reported by parent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial osteopathic manipulative therapyAlso: Cranial osteopathy | Other | Cranial osteopathic manipulative treatment |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Background: PubMed 23158465Miller JE, Newell D, Bolton JE. Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial. J Manipulative Physiol Ther. 2012 Oct;35(8):600-7. doi: 10.1016/j.jmpt.2012.09.010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Jakel, DPhil contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial osteopathic manipulative therapy in people with Infantile Colic, run by European School of Osteopathy at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Jakel, DPhil (annejakel@eso.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinding success and acceptability questionnaire (non-validated) (time frame: up to 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.