Effect of Kinesiotape on Emesis in Pregnant Women

NCT ID: NCT06625632

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2025-01-31

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.

Conditions

Emesis Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping

It will be consisted of 25 pregnant women who will receive kinesiotaping (I band) for 5 days in addition to antiemetic drugs (ondansetron 4 mg, every 12 hours), vitamin B6 (50 mg, once daily), and home care advice.

Group Type: EXPERIMENTAL

Antiemetic Drug

Intervention Type: DRUG

All participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days.

Vitamin B6

Intervention Type: DIETARY_SUPPLEMENT

All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.

Home care advice

Intervention Type: OTHER

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.

Kinesiotaping

Intervention Type: OTHER

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.

Antiemetic drug + Vitamin B6 + Home care advice

It will be consisted of 25 pregnant women who will receive antiemetic drugs (ondansetron 4mg every 12 hours, vitamin B6 (50 mg, once daily), and home care advice only for 5 days.

Group Type: ACTIVE_COMPARATOR

Antiemetic Drug

Intervention Type: DRUG

All participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days.

Vitamin B6

Intervention Type: DIETARY_SUPPLEMENT

All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.

Home care advice

Intervention Type: OTHER

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.

Interventions

Antiemetic Drug

All participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days.

Intervention Type: DRUG

Vitamin B6

All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Ondansetron 4 mg

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Soad Mansour Shawky El-Kholy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azza Barmoud Nashed Kassab, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

Soad Mansour Shawky El-Kholy, B.Sc

Role: CONTACT

soadelkholy3@gmail.com

01026624204

Manal Ahmed El-Shafei, PhD

Role: CONTACT

Facility Contacts

Soad Mansour Shawky El-Kholy, B.Sc

Role: primary

soadelkholy3@gmail.com

01026624204

Manal Ahmed El-Shafei, PhD

Role: backup

Other Identifiers

P.T.REC/012/005305

Identifier Type: -

Identifier Source: org_study_id