Effect of Kinesiotape on Emesis in Pregnant Women

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Antiemetic Drug
  All participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days.
• Пищевая добавка Vitamin B6
  All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.
• Другое 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.
• Другое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Giza

Идентификаторы

NCT: NCT06625632 · P.T.REC/012/005305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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