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Not yet recruiting NCT06625632

Effect of Kinesiotape on Emesis in Pregnant Women

No phase Interventional Emesis Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antiemetic Drug, Vitamin B6, Home care advice, Kinesiotaping.
Who it may be relevant to
Registry conditions: Emesis Pregnancy. Basic parameters: 20 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study will be conducted to investigate the effect of kinesiotaping on emesis in pregnant women.

Detailed description

Emesis gravidarum (EG) is a common condition among pregnant women, with a prevalence of 12.5% worldwide. It has a significant impact on the body where the mother becomes very weak, the face is pale and the frequency of urination decreases drastically so, the body fluids are reduced, and blood becomes thick (hem concentration). This condition can slow down blood circulation so that oxygen and food supply to the tissues are also reduced which can cause tissue damage and endangers the health of the mother and her fetus. Also, EG known to reduce a woman's quality of life (QOL). It was reported that 80% of women with emesis have reduced QOL.

Women with EG fear from the use of the antiemetic drugs and the possible side effects such as drowsiness, sedation, arrhythmia, poor efficacy of pharmacological approach in the past leads to difficulty in the treatment of nausea and vomiting during pregnancy. Non- pharmacological option has been proposed to be effective in the treatment of EG and hyperemesis gravidarum. Such as hypnosis, acustimulation, tactile massage, psychotherapy, acupuncture and kinesiotape.

Kinesiotape 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. The kinesiotaping was found to be effective in stimulation of large and small intestinal peristalsis.

Due to lack of previous studies that examined the effect of kinesiotape on EG. This raises the need of further studies in this issue which will give an insight about the efficacy of kinesiotape as a safe, non-invasive and inexpensive method used to alleviate nausea and vomiting during pregnancy. This will be of valuable benefits in medical service organization and increase body of knowledge of physical therapists in scientific field.

Interventions

  • Drug Antiemetic Drug
    All participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days.
  • Dietary supplement Vitamin B6
    All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.
  • Other Home care advice
    All participants in both groups will be advised to eat small portions of food, drink plenty of liquids, and avoid fatty and fried foods. Additionally, they should steer clear of highly spiced foods, foods and beverages with strong odors, caffeine, and consume neither very hot nor very cold foods and liquids.
  • Other Kinesiotaping
    It will be applied for all participants in the experimental group only for 5 days. The participant will be asked to stand in erect position, her hands beside her body then applying the kinesiotape from origin (from top to bottom where the stomach is placed on the abdominal region) to insertion (alongside the gastric curvature) with tension 25% for 5 days.

Primary outcome measures

  • Visual analogue scale (VAS) [Time frame: 24 hours]
  • Rhodes index [Time frame: 24 hours]
  • Pregnancy unique quantification of emesis (PUQE) [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • Fifty pregnant women at 6th to 12th weeks of gestation diagnosed with mild to moderate nausea and vomiting.
  • The diagnosis of EG is confirmed by Rhodes index.
  • Their ages will be ranged from 20 to 35years old.
  • Their body mass index will be less than 30 kg/m2.
  • All of them are primigravida.

Exclusion criteria

  • Digestive system diseases, inflammatory bowel disease, gastric ulcers and/or esophagitis.
  • Twins or more.
  • Obese women with BMI <30 kg/m2.
  • Severe emesis or hyperemesis gravidarum.
  • Risk of threatened or habitual abortion.
  • Multi gravida.
  • Thyroid or liver dysfunction.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Giza

Identifiers

NCT: NCT06625632 · P.T.REC/012/005305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗