Therapeutic Touch for procedural pain in preterm neonates less than 28 weeks gestational age
| ISRCTN | ISRCTN13204272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13204272 |
| Protocol serial number | CAM 06-315 |
| Sponsor | SickKids Foundation (Canada) |
| Funder | SickKids Foundation (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 of protocol
Not provided at time of registration
Contact information
Dr Celeste Johnston
Scientific
Scientific
3506 University
Montreal
H3A2A6
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Therapeutic Touch for procedural pain in preterm neonates less than 28 weeks gestational age |
| Study acronym | TT- Therapeutic Touch |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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(s) |
Pain response (measured by the Premature Infant Pain Profile) |
| Key secondary outcome measure(s) |
Return to baseline heart rate |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 52 |
| Total final enrolment | 55 |
| Key inclusion criteria | Infants hospitalised in a Neonatal Intensive Care Unit (NICU) and parents are aware of the study and provide full informed consent. |
| Key exclusion criteria | 1. Severe birth asphyxia 2. Major congenital anomalies requiring surgery 3. Currently receiving opioid analgesia or sedatives |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
3506 University
Montreal
H3A2A6
Canada
H3A2A6
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
