Therapeutic Touch for procedural pain in preterm neonates less than 28 weeks gestational age

ISRCTN	ISRCTN13204272
DOI	https://doi.org/10.1186/ISRCTN13204272
Secondary identifying numbers	CAM 06-315

Submission date: 13/03/2006
Registration date: 22/09/2006
Last edited: 07/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Celeste Johnston
Scientific

3506 University
Montreal
H3A2A6
Canada

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Therapeutic Touch for procedural pain in preterm neonates less than 28 weeks gestational age
Study 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(s)	Institutional Review Board, McGill University, Faculty of Medicine, approval given on the 27/07/2005.
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
Primary outcome measure	Pain response (measured by the Premature Infant Pain Profile)
Secondary outcome measures	Return to baseline heart rate
Overall study start date	01/06/2006
Overall study end date	31/05/2007

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	52 infants
Total final enrolment	55
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 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

Study participating centre

3506 University

Montreal
H3A2A6
Canada

Sponsor information

SickKids Foundation (Canada)
Charity

525 University Avenue
14th Floor
Toronto
M5G 2L3
Canada

Website	http://www.sickkidsfoundation.com
"ROR"	https://ror.org/04374qe70

Funders

Funder type

Charity

SickKids Foundation (CAM 06-315)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013	07/01/2021	Yes	No

Editorial Notes

07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.