NCT06259747

Brief Summary

This study will answer the following research question: Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

February 7, 2024

Last Update Submit

February 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • pregnancy unique quantification of emesis and nausea questionnaire

    Frequency of nausea \& vomiting and dry heaviness without vomiting Score. detection of frequency of nausea \& vomiting and dry heaviness without vomiting , total score of frequency of nausea \& vomiting and dry heaviness without vomiting (sum of replies to 1, 2, 3 questions): Mild NVP ≤ 6, Moderate NVP 7-12, severe NVP ≥ 13.

    Measured before treatment , after first treatment (at 4th day) and after second treatment (at 8th day )

  • pregnancy unique quantification of emesis and nausea questionnaire

    Quality of life in those pregnant women Score the quality of life question is on a scale of 0-10 with: 0(worst possible), 10 (as good as you felt before pregnancy).

    Measured before treatment , after first treatment (at 4th day) and after second treatment (at 8th day )

Study Arms (2)

acutaping and traditional medical treatment

EXPERIMENTAL

received acutaping in addition to traditional medical treatment (Doxylamine and Pyridoxine)

Other: AcutapingDrug: Doxylamine and Pyridoxine

traditional medical treatment only

EXPERIMENTAL

received traditional medical treatment only (Doxylamine and Pyridoxine

Drug: Doxylamine and Pyridoxine

Interventions

Application of the kinesio tape on finger and forearm flexor tape after localization of the acupoints of application

acutaping and traditional medical treatment

traditional medical treatment for nausea and vomiting during pregnancy

acutaping and traditional medical treatmenttraditional medical treatment only

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Woman with nausea and vomiting during pregnancy Primigravida With age ranges from 20-35years Gestational age 7-16 weeks Body mass index (BMI) less than 30 kg/m2 Not hospitalized due to hyperemesis gravidarum

You may not qualify if:

  • Gastrointestinal disorder Diabetes Dehydration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour teaching hospital and private clinics

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Conditions

Nausea

Interventions

dicyclomine, doxylamine, pyridoxine drug combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eman Abdelfatah Elhosary, professor at women's health

    Women's Health Department ,Faculty Of Physical Therapy Kafr Elsheikh University

    STUDY DIRECTOR
  • Fayiz Farouk Elshamy, professor at women's health

    Women's Health Department ,Faculty Of Physical Therapy Kafr Elsheikh University

    STUDY DIRECTOR
  • Tamer Mahmoud Zaki, Fellow Obst. and gyna.

    Obestetrics And Gynecology Depatment, Damanhour Teaching Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated into two groups; group (A) will receive acutaping in addition to traditional medical treatment (Doxylamine and Pyridoxine) while group (B) will receive traditional medical treatment(Doxylamine and Pyridoxine) only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at women's health department

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 14, 2024

Study Start

February 3, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations