Condition category
Pregnancy and Childbirth
Date applied
14/04/2009
Date assigned
27/05/2009
Last edited
10/08/2009
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 Gideon Koren

ORCID ID

Contact details

Professor of Pediatrics
Pharmacology
Pharmacy
Medicine and Medical Genetics
Clinician-Scientist
The Hospital for Sick Children
Division of Clinical Pharmacology
Rm 8232
555 University Ave
Toronto
M5G 1X8
Canada
+1 416 813 1500 ext. 5781
gkoren@sickkids.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REB#-08-030

Study information

Scientific title

The effect of reiki on pain in women who will undergo non-emergency caesarean sections and the effect of genetic variation on the use of codeine: a randomised controlled trial

Acronym

REPA

Study hypothesis

Can reiki reduce pain after caesarean section by more than 25%?

Ethics approval

St. Michael's Hospital Ethics Review Board approved on the 12th May 2008 (ref: 08-030)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain levels after caesarean section

Intervention

1. Control group: usual care
2. Reiki Group: usual care plus 20 minutes of Remote Reiki

Duration: three days while in the hospital.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Visual Analogue Scale for pain in movement, at day 1, day 2 and day 3 (amended as of 10/08/09; initial outcome timepoints were 'after 72 hours in hospital').

Secondary outcome measures

1. Visual Analogue Scale for pain (in rest)
2. Pain medication (codeine consumption/kg)
3. Return time to normal activities

All measured at day 1, day 2 and day 3 (amended as of 10/08/09; initial outcome timepoints were 'after 72 hours in hospital').

Overall trial start date

30/06/2008

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent
2. Planned caesarean section
3. Pregnant women aged 18 - 48 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

Does not meet with inclusion criteria

Recruitment start date

30/06/2008

Recruitment end date

30/04/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Professor of Pediatrics, Pharmacology, Pharmacy, Medicine and Medical Genetics
Toronto
M5G 1X8
Canada

Sponsor information

Organisation

The Hospital for Sick Children (Canada)

Sponsor details

c/o Gideon Koren
Professor of Pediatrics
Pharmacology
Pharmacy
Medicine and Medical Genetics
Clinician-Scientist
Division of Clinical Pharmacology
Rm 8232
555 University Ave
Toronto
M5G 1X8
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.sickkids.ca/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Canada)

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