NauseaNCT06259747
Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy
A study testing Acutaping and Doxylamine and Pyridoxine in people with Nausea and Vomiting of Pregnancy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study will answer the following research question: Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy? Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Nausea, Vomiting of Pregnancy
- What is being tested?
- Acutaping and Doxylamine and Pyridoxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2023to 15 Dec 2023
- 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
- 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
Who cannot join
- Gastrointestinal disorder Diabetes Dehydration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy
This study will answer the following research question:
Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy?
Read the detailed description
Nausea and vomiting during pregnancy (NVP) are common symptoms, with prevalence rate from 50% to 90% . NVP symptoms often appear between weeks 5 and 6, peak at 8 to 9 weeks, and subside between weeks 16 and 20 .Long-term morning sickness during pregnancy increases the incidence of postpartum depression symptoms in women and severe NVP increases the chance of low birth weight .
NVP is multifactorial and the most common causes potentially including hormone imbalances, placental disorders, and genetic causes . Genetic factors, Evidence in support of a genetic predisposition to nausea and vomiting of pregnancy includes the following: (a) the concordance in frequency of nausea and vomiting of pregnancy in monozygotic twins ; (b) the finding that siblings and mothers of patients affected with nausea and vomiting of pregnancy are more likely to be affected than relatives of unaffected individuals ; (c) the variation in frequency between ethnic groups; (d) the higher frequency of nausea and vomiting of pregnancy in patients with predisposing conditions that are genetically determined such as taste sensation; and (e) the occurrence of nausea and vomiting of pregnancy in women with inherited glycoprotein hormone receptor defects.
The fundamental stimulus-a placental product, the triggering factor for nausea and vomiting of pregnancy has not been identified, although human chorionic gonadotropin and estrogens have been implicated. The principle reason for considering human chorionic gonadotropin initially was the close temporal association between peak human chorionic gonadotropin concentrations and peak nausea and vomiting of pregnancy symptoms. Conditions associated with higher human chorionic gonadotropin production are associated with nausea and vomiting of pregnancy. These include multiple gestation with hyperemesis gravidarum 4 to 5 times more common than in singletons .
Whatever the specific trigger, the emetic response is fundamentally the same: there is a marked reduction in gastric tone and motility followed by a retrograde giant contraction moving small intestinal contents into the stomach. Thereafter, contractions of the diaphragm and abdominal muscles combine with relaxation of the gastroesophageal sphincter to facilitate passage of gastrointestinal contents .
Although there are several pharmacological treatments for NVP, many medical professionals and expectant mothers prefer non-pharmacological therapy over pharmacological ones because of worry for their impact on foetal outcomes .
For years, traditional Chinese acupuncture has been promoted as a helpful antiemetic . An alternative treatment for preventing nausea and vomiting is acupressure .
Kinesio tape is an elastic therapeutic tape that is drug free and used to treat a range of musculoskeletal issues, including dysfunction, pain, and injury and a variety of other disorders .When compared to normal drugs alone, kinesio taping on the stomach area is more successful at relieving nausea and vomiting in emesis gravidarum patients .
In acutaping, acupressure/acupuncture and kinesio taping are used to treat internal and gynecological issues like nausea and vomiting during pregnancy by stimulating acupressure points with kinesio tape .
Nausea and vomiting of pregnancy is a very common disorder reported in 70-80% of all pregnant women . The extent of vomiting may be so profound that weight loss, electrolyte imbalance, and dehydration requiring hospitalisation result . Women with nausea and vomiting during pregnancy and nausea only during pregnancy had proteinuria and preeclampsia than the symptom free women .NVP also has a significant detrimental impact on quality of life (QoL) , especially affecting physical QoL and work function. This impact is evident across the spectrum of NVP, but significantly worse with more severe symptoms .
Studies have repeatedly shown that there is a high perception of teratogenic risk among pregnant and planning women regarding medication use in pregnancy , and that this is also true for NVP , which is experienced by the vast majority of pregnant women.
There are many studies using acustimulation on nausea and vomiting in pregnant women including acupressure, acupuncture, and electrical stimulation.The stimulation of this point can also be done by dry cupping and also auriculotherapy used for NVP .
There is no study about the potential therapeutic implication of acutaping on nausea and vomiting during pregnancy, so our study will be used to detect this therapeutic implication of acutaping.
- Conditions
- Nausea, Vomiting of Pregnancy
- Being tested
- Acutaping, Doxylamine and Pyridoxine
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcutapingOther
Application of the kinesio tape on finger and forearm flexor tape after localization of the acupoints of application
Doxylamine and PyridoxineDrug
traditional medical treatment for nausea and vomiting during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| acutaping and traditional medical treatment | Experimental | received acutaping in addition to traditional medical treatment (Doxylamine and Pyridoxine) Receives: Other: Acutaping; Drug: Doxylamine and Pyridoxine |
| traditional medical treatment only | Experimental | received traditional medical treatment only (Doxylamine and Pyridoxine Receives: Drug: Doxylamine and Pyridoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured before treatment , after first treatment (at 4th day) and after second treatment (at 8th day )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start3 Feb 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Hassan Mohamed Elghoul, Kafrelsheikh University
- Investigators
- Eman Abdelfatah Elhosary, professor at women's health, Study director, Women's Health Department ,Faculty Of Physical Therapy Kafr Elsheikh UniversityFayiz Farouk Elshamy, professor at women's health, Study director, Women's Health Department ,Faculty Of Physical Therapy Kafr Elsheikh UniversityTamer Mahmoud Zaki, Fellow Obst. and gyna., Study director, Obestetrics And Gynecology Depatment, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259747
- Sponsor's protocol ID
- Acutaping for NVP
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy
- ClinicalTrials.gov ID
- NCT06259747
- Acronym / sponsor ID
- Acutaping for NVP
- Conditions
- Nausea, Vomiting of Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 14 Feb 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 answer the following research question:
Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy?
Detailed description
Nausea and vomiting during pregnancy (NVP) are common symptoms, with prevalence rate from 50% to 90% . NVP symptoms often appear between weeks 5 and 6, peak at 8 to 9 weeks, and subside between weeks 16 and 20 .Long-term morning sickness during pregnancy increases the incidence of postpartum depression symptoms in women and severe NVP increases the chance of low birth weight .
NVP is multifactorial and the most common causes potentially including hormone imbalances, placental disorders, and genetic causes . Genetic factors, Evidence in support of a genetic predisposition to nausea and vomiting of pregnancy includes the following: (a) the concordance in frequency of nausea and vomiting of pregnancy in monozygotic twins ; (b) the finding that siblings and mothers of patients affected with nausea and vomiting of pregnancy are more likely to be affected than relatives of unaffected individuals ; (c) the variation in frequency between ethnic groups; (d) the higher frequency of nausea and vomiting of pregnancy in patients with predisposing conditions that are genetically determined such as taste sensation; and (e) the occurrence of nausea and vomiting of pregnancy in women with inherited glycoprotein hormone receptor defects.
The fundamental stimulus-a placental product, the triggering factor for nausea and vomiting of pregnancy has not been identified, although human chorionic gonadotropin and estrogens have been implicated. The principle reason for considering human chorionic gonadotropin initially was the close temporal association between peak human chorionic gonadotropin concentrations and peak nausea and vomiting of pregnancy symptoms. Conditions associated with higher human chorionic gonadotropin production are associated with nausea and vomiting of pregnancy. These include multiple gestation with hyperemesis gravidarum 4 to 5 times more common than in singletons .
Whatever the specific trigger, the emetic response is fundamentally the same: there is a marked reduction in gastric tone and motility followed by a retrograde giant contraction moving small intestinal contents into the stomach. Thereafter, contractions of the diaphragm and abdominal muscles combine with relaxation of the gastroesophageal sphincter to facilitate passage of gastrointestinal contents .
Although there are several pharmacological treatments for NVP, many medical professionals and expectant mothers prefer non-pharmacological therapy over pharmacological ones because of worry for their impact on foetal outcomes .
For years, traditional Chinese acupuncture has been promoted as a helpful antiemetic . An alternative treatment for preventing nausea and vomiting is acupressure .
Kinesio tape is an elastic therapeutic tape that is drug free and used to treat a range of musculoskeletal issues, including dysfunction, pain, and injury and a variety of other disorders .When compared to normal drugs alone, kinesio taping on the stomach area is more successful at relieving nausea and vomiting in emesis gravidarum patients .
In acutaping, acupressure/acupuncture and kinesio taping are used to treat internal and gynecological issues like nausea and vomiting during pregnancy by stimulating acupressure points with kinesio tape .
Nausea and vomiting of pregnancy is a very common disorder reported in 70-80% of all pregnant women . The extent of vomiting may be so profound that weight loss, electrolyte imbalance, and dehydration requiring hospitalisation result . Women with nausea and vomiting during pregnancy and nausea only during pregnancy had proteinuria and preeclampsia than the symptom free women .NVP also has a significant detrimental impact on quality of life (QoL) , especially affecting physical QoL and work function. This impact is evident across the spectrum of NVP, but significantly worse with more severe symptoms .
Studies have repeatedly shown that there is a high perception of teratogenic risk among pregnant and planning women regarding medication use in pregnancy , and that this is also true for NVP , which is experienced by the vast majority of pregnant women.
There are many studies using acustimulation on nausea and vomiting in pregnant women including acupressure, acupuncture, and electrical stimulation.The stimulation of this point can also be done by dry cupping and also auriculotherapy used for NVP .
There is no study about the potential therapeutic implication of acutaping on nausea and vomiting during pregnancy, so our study will be used to detect this therapeutic implication of acutaping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| acutaping and traditional medical treatment | Experimental | Other: Acutaping, Drug: Doxylamine and Pyridoxinereceived acutaping in addition to traditional medical treatment (Doxylamine and Pyridoxine) |
| traditional medical treatment only | Experimental | Drug: Doxylamine and Pyridoxinereceived traditional medical treatment only (Doxylamine and Pyridoxine |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Gastrointestinal disorder Diabetes Dehydration
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 |
|---|---|---|
| AcutapingApplication of the kinesio tape on finger and forearm flexor tape after localization of the acupoints of application | Other | acutaping and traditional medical treatment |
| Doxylamine and Pyridoxinetraditional medical treatment for nausea and vomiting during pregnancy | Drug | acutaping and traditional medical treatment, traditional medical treatment only |
Primary outcome
pregnancy unique quantification of emesis and nausea questionnaire
Time frame: Measured before treatment , after first treatment (at 4th day) and after second treatment (at 8th day )
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.
pregnancy unique quantification of emesis and nausea questionnaire
Time frame: Measured before treatment , after first treatment (at 4th day) and after second treatment (at 8th day )
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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.
Eman Abdelfatah Elhosary, professor at women's health study director
Women's Health Department ,Faculty Of Physical Therapy Kafr Elsheikh University
Fayiz Farouk Elshamy, professor at women's health study director
Women's Health Department ,Faculty Of Physical Therapy Kafr Elsheikh University
Tamer Mahmoud Zaki, Fellow Obst. and gyna. study director
Obestetrics And Gynecology Depatment, Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acutaping and Doxylamine and Pyridoxine in people with Nausea and Vomiting of Pregnancy, run by Kafrelsheikh 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy unique quantification of emesis and nausea questionnaire (time frame: Measured before treatment , after first treatment (at 4th day) and after second treatment (at 8th day )). The study lists 2 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 16 Feb 2024.