CAN KINESIO TAPING BE A NOVEL TREATMENT OPTION FOR EMESIS GRAVIDARUM? A RANDOMIZED PRELIMINARY STUDY

Last registered on February 14, 2016
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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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
February 14, 2016, 5:14 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Turkey
Region
van

Primary Investigator

Name
Erbil Karaman
Affiliation
YuzuncuYıl University Faculty of Medicine
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Other Primary Investigator(s)

PI Name
Orkun çetin
PI Affiliation
yuzuncu yil university, department of obstetric and gynecology
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Additional Trial Information

Status
Completed
Start date
2015-12-19
End date
2016-02-14
Keywords
Health
Additional Keywords
JEL code(s)
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 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://www.socialscienceregistry.org/trials/1054/history/6842
Sponsors & Partners
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)
Supporting Documents and Materials
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
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials