Clinical trial NCT06625632: Effect of Kinesiotape on Emesis in Pregnant Women
Official title: Effect of Kinesiotape on Emesis in Pregnant Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emesis Pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 24 hours
measure: Rhodes index
timeFrame: 24 hours
measure: Pregnancy unique quantification of emesis (PUQE)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor, Cairo university
name: Azza Barmoud Nashed Kassab, PhD
role: STUDY_CHAIR
References: