Condition category
Pregnancy and Childbirth
Date applied
13/03/2006
Date assigned
22/09/2006
Last edited
22/09/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Celeste Johnston

ORCID ID

Contact details

3506 University
Montreal
H3A2A6
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CAM 06-315

Study information

Scientific title

Acronym

TT- Therapeutic Touch

Study hypothesis

1. Infants receiving Therapeutic Touch (TT) will show a lower pain score (Premature Infant Pain Profile [PIPP]) in response to heel lance for blood sampling for clinical purposes.
2. Infants receiving TT will have a shorter recovery (return to baseline heart rate) from heel lance for blood sampling for clinical purposes.

Ethics approval

Institutional Review Board, McGill University, Faculty of Medicine, approval given on the 27/07/2005.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Preterm infant pain

Intervention

Therapeutic Touch (TT) is a non-invasive method used in other populations to calm and comfort. TT is a form of energy therapy provided by a trained practitioner. The practitioner uses the hands to assess and rebalance the energy field of the patient.

In the control group, the therapist stands at the incubator with their hands at the side and performs mental math calculations. This is neither a sham therapeutic touch nor usual care, in that therapist will actually be standing beside the patient, behind screen to keep the condition masked for those caring for the infant.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain response (measured by the Premature Infant Pain Profile)

Secondary outcome measures

Return to baseline heart rate

Overall trial start date

01/06/2006

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Infants hospitalised in a Neonatal Intensive Care Unit (NICU) and parents are aware of the study and provide full informed consent.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

52 infants

Participant exclusion criteria

1. Severe birth asphyxia
2. Major congenital anomalies requiring surgery
3. Currently receiving opioid analgesia or sedatives

Recruitment start date

01/06/2006

Recruitment end date

31/05/2007

Locations

Countries of recruitment

Canada

Trial participating centre

3506 University
Montreal
H3A2A6
Canada

Sponsor information

Organisation

SickKids Foundation (Canada)

Sponsor details

525 University Avenue
14th Floor
Toronto
M5G 2L3
Canada

Sponsor type

Charity

Website

http://www.sickkidsfoundation.com

Funders

Funder type

Charity

Funder name

SickKids Foundation (CAM 06-315)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes