Emesis PregnancyNCT06625632
Effect of Kinesiotape on Emesis in Pregnant Women
A study testing Antiemetic Drug, Vitamin B6 and Home care advice in people with Emesis Pregnancy, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of kinesiotaping on emesis in pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Emesis Pregnancy
- What is being tested?
- Antiemetic Drug, Vitamin B6 and Home care advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Manal Ahmed El-Shafei, PhD contact
Egypt1 site
Cairo University
Giza
Soad Mansour Shawky El-Kholy, B.Sc, 01026624204, soadelkholy3@gmail.com
Manal Ahmed El-Shafei, PhD
About this study
This study will be conducted to investigate the effect of kinesiotaping on emesis in pregnant women.
Read the 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
- Being tested
- Antiemetic Drug, Vitamin B6, Home care advice, Kinesiotaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiemetic DrugDrug
Also called Ondansetron 4 mg
All participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days.
Vitamin B6Dietary supplement
All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.
Home care adviceOther
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.
KinesiotapingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Antiemetic Drug; Dietary Supplement: Vitamin B6; Other: Home care advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start7 Oct 2024 (estimated)
- Primary completion7 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emesis PregnancyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Mansour Shawky El-Kholy, Cairo University
- Investigators
- Azza Barmoud Nashed Kassab, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625632
- Sponsor's protocol ID
- P.T.REC/012/005305
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotape on Emesis in Pregnant Women
- ClinicalTrials.gov ID
- NCT06625632
- Acronym / sponsor ID
- P.T.REC/012/005305
- Conditions
- Emesis Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Oct 2024 (estimated)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping | Experimental | Drug: Antiemetic Drug, Dietary Supplement: Vitamin B6, Other: Home care advice, Other: KinesiotapingIt 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. |
| Antiemetic drug + Vitamin B6 + Home care advice | Active comparator | Drug: Antiemetic Drug, Dietary Supplement: Vitamin B6, Other: Home care adviceIt 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiemetic DrugAlso: Ondansetron 4 mgAll participants in the two groups will receive antiemetic drugs (ondansetron 4 mg) every 12 hours, for 5 days. | Drug | Antiemetic drug + Vitamin B6 + Home care advice, Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping |
| Vitamin B6All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days. | Dietary supplement | Antiemetic drug + Vitamin B6 + Home care advice, Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping |
| Home care adviceAll 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. | Other | Antiemetic drug + Vitamin B6 + Home care advice, Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping |
| KinesiotapingIt 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. | Other | Antiemetic drug + Vitamin B6 + Home care advice + Kinesiotaping |
Primary outcome
Visual analogue scale (VAS)
Time frame: 24 hours
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.
Rhodes index
Time frame: 24 hours
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.
Pregnancy unique quantification of emesis (PUQE)
Time frame: 24 hours
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Ahmed El-Shafei, PhD contact
Azza Barmoud Nashed Kassab, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiemetic Drug, Vitamin B6 and Home care advice in people with Emesis Pregnancy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soad Mansour Shawky El-Kholy, B.Sc (01026624204, soadelkholy3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.