The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy
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|ClinicalTrials.gov Identifier: NCT01617837|
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : September 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting Acupressure Craniotomy||Device: P6 acupressure band Other: Placebo band||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy. - a Randomized, Double-blinded, Placebo Controlled Study.|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: P6 acupressure group
In the end of the operation Sea-Band®, a single-sized elastic acupressure band with a plastic button, was placed unilaterally at the place of P6 (the P6 "Neiguan" acupoint, located about 3 cm proximal to the distal wrist, between the tendons of the flexor carpi radialis and the palmaris longus)to apply acupressure.
Device: P6 acupressure band
Comparison between groups 0-48 hours postoperatively.
Other Name: Sea-Band®
Placebo Comparator: Placebo group
In the end of the operation an identical Sea-Band® with no button and thereby no acupressure was placed unilaterally at the place of P6.
Other: Placebo band
Comparison between groups 0-48 hours postoperatively
Other Name: Sea-Band® with no acupressure
- Postoperative nausea and vomiting [ Time Frame: Postperative nauea and vomiting are registred regularly 0-48 hours postperatively. ]During 48 hours postoperatively the patients are evaluating their nausea, registered on the same formula as the frequencies of vomiting. The first evaluation will take part when arriving to the postoperative care unit and then every hour for the first six hours, every third hour until hour 24 and thereafter every sixth hour from hour 24-48. A Numerical Rating Scale (NRS) from 0-10 will be used, where 0 means no nausea at all and 10 the worst nausea possible. The patients will be asked about whether they have experienced any nausea within the previous period of time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617837
|The Department of Neurosurgery, Umeå University Hospital|
|Umeå, Västerbotten, Sweden, 90185|
|Study Director:||Ulrica Nilsson, PhD||Umeå University|