Effect of Kinesiotape on Emesis in Pregnant Women

NCT06625632 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005305
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Emesis Pregnancy

Outcome Measures

Primary Outcomes (3)

• Visual analogue scale (VAS)

  It will be used for all participants in both groups pre and post-treatment to assess the severity of symptoms of emesis gravidarum. Patients will be asked on their first visit to grade the severity of their nausea over the past 24 hours (baseline scores) by marking an "X" corresponding to their perceived states on a 10-cm horizontal line, ranging from 0 no nausea to 10 nausea as bad as it could be. On the following 2 weeks of treatment, recordings of the severity of nausea will be made twice daily at noon and at bedtime.

  24 hours

• Rhodes index

  It will be used for all participants in both groups pre and post-treatment to assess severity of nausea and vomiting for all participants in both groups before and after the study. Each woman will be asked to self-report questions such as length and episodes of nausea, number of vomits, number of retches, and volume of vomits on the 5-point scale with 1 indicating minimal or no symptom and 5 representing the worst symptom.

  24 hours

• Pregnancy unique quantification of emesis (PUQE)

  It will be used for all participants in both groups pre and post-treatment to assess the symptoms of emesis gravidarum. This questionnaire contains three questions regarding the time-span of nausea, vomiting and retching respectively, as well as one question assessing the global psychological and physical quality of life (QOL). Each woman will be asked to choose the answer that suit the best of her situation for the last 24 hours. The PUQE score is calculated by adding the values from each category, and can range from a minimum of 1 to a maximum of 15, with higher scores indicating worse outcome.

  24 hours

Study Arms (2)

Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping

EXPERIMENTAL

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.

Drug: Antiemetic Drug; Dietary Supplement: Vitamin B6; Other: Home care advice; Other: Kinesiotaping

Antiemetic drug + Vitamin B6 + Home care advice

ACTIVE COMPARATOR

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.

Drug: Antiemetic Drug; Dietary Supplement: Vitamin B6; Other: Home care advice

Interventions

Antiemetic Drug DRUG

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

Also known as: Ondansetron 4 mg

Antiemetic drug + Vitamin B6 + Home care advice; Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping

Vitamin B6 DIETARY_SUPPLEMENT

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

Antiemetic drug + Vitamin B6 + Home care advice; Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping

Home care advice 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.

Antiemetic drug + Vitamin B6 + Home care advice; Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping

Kinesiotaping 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 + Kinesiotaping

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Antiemetics; Ondansetron; Vitamin B 6

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Picolines; Pyridines

Study Officials

• Azza Barmoud Nashed Kassab, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Soad Mansour Shawky El-Kholy, B.Sc

CONTACT

01026624204; soadelkholy3@gmail.com

Manal Ahmed El-Shafei, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: October 7, 2024
• Primary Completion: January 7, 2025
• Study Completion: January 31, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

EG (1)