CAN KINESIO TAPING BE A NOVEL TREATMENT OPTION FOR EMESIS GRAVIDARUM? A RANDOMIZED PRELIMINARY STUDY
Last registered on February 14, 2016

Pre-Trial

Trial Information
General Information
Title
CAN KINESIO TAPING BE A NOVEL TREATMENT OPTION FOR EMESIS GRAVIDARUM? A RANDOMIZED PRELIMINARY STUDY
RCT ID
AEARCTR-0001054
Initial registration date
February 14, 2016
Last updated
February 14, 2016 5:14 PM EST
Location(s)
Region
Primary Investigator
Affiliation
YuzuncuYıl University Faculty of Medicine
Other Primary Investigator(s)
PI Affiliation
yuzuncu yil university, department of obstetric and gynecology
Additional Trial Information
Status
Completed
Start date
2015-12-19
End date
2016-02-14
Secondary IDs
Abstract
Kinesio tape is a drug-free and an elastic therapeutic tape used for treating various musculoskeletal problems such as injury, pain, and dysfunction and a variety of other disorders[9]. The kinesiotaping was found to be effective in stimulation of large and small intestinal peristaltism and treated constipation in a case report[10]. Kinesio taping aplications were created by a Japanese chiropractor, Dr Kenso Kase, in the 1970s. Although the exact mechanisms of the effects of are not yet clear, some investigators claimed that Kinesio taping has multiple functions. The inventor stated that the tape should be applied from origin to insertion to inhibit msucle function[10, 11]. The vomiting is chracterised by the retrograd peristaltism(movement) of gastrointestinal smooth muscle function. So the hypothesis of our study is based on the inhibition of retrograd peristaltism of gastrointestinal system by applying the kinesiotape from origin(from top to bottom where the stomach is placed on the abdominal region) to insertion(alongside the gastric curvature) so as to decrease the vomiting and maybe nause which is predominately induced by the central nervous system

To investigate the effect of Kinesio taping on nausea and vomiting in women with emesis gravidarum.
External Link(s)
Registration Citation
Citation
Karaman, Erbil and Orkun çetin. 2016. "CAN KINESIO TAPING BE A NOVEL TREATMENT OPTION FOR EMESIS GRAVIDARUM? A RANDOMIZED PRELIMINARY STUDY." AEA RCT Registry. February 14. https://doi.org/10.1257/rct.1054-1.0.
Former Citation
Karaman, Erbil, Erbil Karaman and Orkun çetin. 2016. "CAN KINESIO TAPING BE A NOVEL TREATMENT OPTION FOR EMESIS GRAVIDARUM? A RANDOMIZED PRELIMINARY STUDY." AEA RCT Registry. February 14. http://www.socialscienceregistry.org/trials/1054/history/6842.
Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2015-12-19
Intervention End Date
2016-02-14
Primary Outcomes
Primary Outcomes (end points)
There was no statistically significant difference between the two groups regarding mean of age, gravidity, parity, body mass index, gestational weeks at admission. Both groups showed a significant reduction in nausea and vomiting after the treatments. However, when considering the decrease in PUQE scores and VAS scores in groups from baseline at admission to the fifth day of treatment, the Kinesio tape group was significantly superior than the control group(p=0.048).
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
This prospective, randomized study included 77 women divided randomly into two groups. The study group received standard medications as metaclopramide(10 mg) twice in a day and vitamin B6(30 mg) single dose in a day and was performed Kinesio taping on the stomach region over the abdomen, while the control group received only the standard medications for treatment of emesis gravidarum. The degree of nausea and vomiting was evaluated by a 10-cm visual analogue scale (VAS) and Pregnancy unique quantification of emesis (PUQE) scoring.
Experimental Design Details
Randomization Method
randomisation by a computer generated program
Randomization Unit
The study were designed to two group randomisation.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
39 for group 1 and 38 for group 2
Sample size: planned number of observations
2
Sample size (or number of clusters) by treatment arms
39 fvor group 1
38 for group 2
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Yuzuncu yıl university, medical faculty, ethical approval board
IRB Approval Date
2015-12-18
IRB Approval Number
02
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers