Hyperemesis GravidarumPREGNANCYNCT06442813
Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
A study testing EFT GROUP in people with Hyperemesis Gravidarum and Pregnancy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical study is to determine whether EFT (Emotional Freedom Techniques) is effective in alleviating nausea and vomiting in pregnant women with hyperemesis. Additionally, the study aims to gather information on the safety of EFT application. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperemesis Gravidarum, Pregnancy
- What is being tested?
- EFT GROUP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 30 Aug 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between 6-14 weeks of pregnancy
- Pregnant women between the ages of 20-40
- Pregnant women with complaints of nausea and vomiting
- Pregnant women who report their discomfort as 5 or above on the vas scale
- Pregnant women who have not been diagnosed with risky pregnancy
- Pregnant women who do not have any psychological disorders
- Pregnant women who voluntarily agreed to participate in the research
Who cannot join
- Coordination and language problems in the pregnant woman
- Wants to leave the study at any time
- Not wanting to participate in the study
Trial locations and contacts
1 site in 1 country.
LECTURER contact
Turkey (Türkiye)1 site
Bezmialem Vakif Universty
Istanbul, Fatih, 34093
Merve MESEDUZU, 800-555-5555, mervemeseduzu@gmail.com
Merve MESEDUZU
About this study
The purpose of this clinical study is to determine whether EFT (Emotional Freedom Techniques) is effective in alleviating nausea and vomiting in pregnant women with hyperemesis. Additionally, the study aims to gather information on the safety of EFT application. The primary questions it seeks to answer are:
Does EFT reduce nausea and vomiting in pregnant women with hyperemesis? Is EFT applicable for use in pregnant women with hyperemesis? Researchers will compare the effectiveness of EFT to traditional nursing education on non-pharmacological interventions for preventing nausea and vomiting in pregnant women with hyperemesis.
Read more
Participants:
Pre-EFT application survey scale questions will be asked to the pregnant women with hyperemesis.
EFT will be applied once by the researcher to the pregnant women with hyperemesis.
For control, the same survey scale questions will be asked to the same pregnant women two days after the EFT application for post-test purposes.
For control, the same survey scale questions will be asked to the same pregnant women seven days after the EFT application for post-test purposes.
The same procedures will be applied in the same manner to the control group that will receive education.
Read the detailed description
Type of Research: It is planned to be randomized, controlled and experimental. Place and Characteristics of the Research: The research will be carried out in the women health and diseases service and Gynecology polyclinics of Bezmialem Vakif University Faculty of Medicine Central Hospital.
Population and Sample of the Research:The sample size was determined as a minimum of 74 people in total using the G Power 3.1 method. The effect size was determined using the t test values in the reference study in which the scale was used with a similar patient group.
Criteria for Inclusion in the Study:Pregnant women who are between 6 and 14 weeks of gestation, aged between 20 and 40 years old, and have complaints of nausea and vomiting are eligible for the study. These participants should report their discomfort as 5 or above on the VAS scale. Additionally, they must not have been diagnosed with a high-risk pregnancy or any psychological disorders. Lastly, they must voluntarily agree to participate in the study.
Criteria for Exclusion from the Study: Exclusion criteria are the presence of coordination and language problems in the pregnant woman and her desire to leave the study at any time or not to participate.
Survey Scales Descriptive Information Form: The pregnancy information form, prepared in line with the literature review conducted by the researchers, includes socio-demographic (age of the pregnant woman, education and employment status, income level, family type and place of residence), obstetric (current gestational week and pregnancy history), psychosocial information. It consists of questions about social and medical history (pregnancy desire), whether there is a chronic disease) and VAS Scale. VAS is a measurement tool used to measure both pain intensity and pain relief, which is simple, effective and repeatable and requires minimal tools.
- Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24): its form specific to the pregnancy period that evaluates nausea and vomiting for the last 12 hours. It was later reported that it would be more appropriate to evaluate the last 24 hours for clinical use, as the last 12 hours sometimes include the sleep period in terms of nausea and vomiting in pregnant women. Thereupon, the Pregnancy-Unique Quantification of Emesis (PUQE-24) Scale was developed and evaluate the severity of pregnancy-specific nausea and vomiting in the last 24 hours. Its Turkish validity and reliability were conducted.
Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) consists of 3 questions:duration of nausea or stomach discomfort, number of vomiting episodes, and number of retching episodes. Answers to the questions are scored between 1 and 5 points. The total score of the scale is obtained by the sum of the scores of the answers given to the questions. The lowest possible score that can be obtained from the scale is 3 and the highest score is 15. If the total score obtained as a result of the PUQE-24 scoring system is 3-6, it is considered mild, 7-12 is considered moderate, and 13-15 is considered severe nausea and vomiting. The scale has no subdimensions. Cronbacha alpha value of the Turkish version of the scale is 0.75.
3.World Health Organization Quality of Life Scale: The WHOQOL-100 scale was developed with the participation of 15 centers from many countries. This scale allows cross-cultural comparisons. WHOQOL-100 was later abbreviated as WHOQOLBREF. WHOQOL-BREF consists of four sub-dimensions: physical domain, spiritual domain, social domain and environmental domain. The validity and reliability of the World Health Organization Quality of Life Scale 31 Short Form-Turkish Version (WHOQOL-BREF-TR) in Turkey was determined. WHOQOL-BREF-TR used in this study consists of 27 questions. For each question, there are options that can be scored between 1 and 5. The scale does not have a total score. The score range that can be obtained from each other sub-dimension is obtained by multiplying the arithmetic mean of that sub-dimension by 4. The score range that can be received for each sub-dimension is between 4-20. Increasing scores from the subscales indicate that the quality of life also increases
- Conditions
- Hyperemesis Gravidarum, Pregnancy
- Being tested
- EFT GROUP
- Keywords
- hyperemesis gravidarum, quality life, pregnancy, Emotional Freedom Techniques
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFT GROUPBehavioural
Also called emotıonal free technıcal
One times one pregnancy
| Study group | Role | What they receive |
|---|---|---|
| EXPERİMENTAL GROUP | Experimental | First Stage: Determining the groups by randomization method and filling out the data collection forms for the groups (pre-test).
Second Stage: Training pregnant women in the control group on the management of standard hyperemesis gravidarum (training content will be prepared and opinions will be obtained from 3 experts in the field).
For the intervention group, pregnant women were given a session with EFT (Average: 40-60 minutes) and a program was created for the pregnant woman to do affirmations in between depending on her condition (Positiveness with EFT strokes 3 times a day).
Third Stage: After 15 days, it is planned to conduct post-tests for both groups and complete the study. In the final stage, pregnant women\'s questions will be answered, counseling will continue where deemed necessary, and prepared training booklets will be given to pregnant women Receives: Behavioral: EFT GROUP |
| CONTROL GROUP | No intervention | Pregnant women diagnosed with hyperemesis gravidarum (HG) who meet the inclusion criteria for the study will constitute the control group. Providing training to the control group only for HG management (training content will be prepared and opinions will be obtained from 3 experts in the field). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24)
The degree of reduction in the severity of nausea and vomiting. The PUQE-24 (Pregnancy-Unique Quantification of Emesis and Nausea) scale is used, where each question is scored between 1 and 5. The total score is the sum of these three questions. Minimum Score: 3 (each question scoring 1) Maximum Score: 15 (each question scoring 5) These scores are used to rate the severity of nausea and vomiting in pregnancy. Lower scores indicate milder symptoms, while higher scores indicate more severe symptoms.
Measured: 3 months
Secondary outcomes (1)
WHOQOL-BREF (World Health Organization Quality of Life - BREF)
Evaluation of improvements in quality of life or psychological well-being, patient satisfaction with the treatment, and reduction in the need for pharmacological interventions. The WHOQOL-BREF (World Health Organization Quality of Life - BREF) scale is used, which comprises 26 items covering four domains: physical health, psychological health, social relationships, and environment. Each domain is scored between 0 and 100. Minimum Score: 0 (poorer quality of life) Maximum Score: 100 (better quality of life)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Jun 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- EXPERIMENTAL GROUP First Stage: Determining the groups by randomization method and filling out the data collection forms for the groups (pre-test). Second Stage: Training pregnant women in the control group on the management of standard hyperemesis gravidarum (training content will be prepared and opinions will be obtained from 3 experts in the field). For the intervention group, pregnant women were given a session with EFT (Average: 40-60 minutes) and a program was created for the pregnant woman to do affirmations in between depending on her condition (Positiveness with EFT strokes 3 times a day). Third Stage: After 15 days, it is planned to conduct post-tests for both groups and
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Meşedüzü, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442813
- Sponsor's protocol ID
- E-54022451-050.05.04-91178
- Other IDs
- MMeseduzu
- Acronym
- PREGNANCY
- Status last verified
- May 2024
- First submitted
- 12 Jan 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
- ClinicalTrials.gov ID
- NCT06442813
- Acronym / sponsor ID
- PREGNANCY / E-54022451-050.05.04-91178
- Conditions
- Hyperemesis Gravidarum, Pregnancy
- Keywords
- hyperemesis gravidarum, quality life, pregnancy, Emotional Freedom Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 4 Jun 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.
The purpose of this clinical study is to determine whether EFT (Emotional Freedom Techniques) is effective in alleviating nausea and vomiting in pregnant women with hyperemesis. Additionally, the study aims to gather information on the safety of EFT application. The primary questions it seeks to answer are:
Does EFT reduce nausea and vomiting in pregnant women with hyperemesis? Is EFT applicable for use in pregnant women with hyperemesis? Researchers will compare the effectiveness of EFT to traditional nursing education on non-pharmacological interventions for preventing nausea and vomiting in pregnant women with hyperemesis.
Participants:
Pre-EFT application survey scale questions will be asked to the pregnant women with hyperemesis.
EFT will be applied once by the researcher to the pregnant women with hyperemesis.
For control, the same survey scale questions will be asked to the same pregnant women two days after the EFT application for post-test purposes.
For control, the same survey scale questions will be asked to the same pregnant women seven days after the EFT application for post-test purposes.
The same procedures will be applied in the same manner to the control group that will receive education.
Detailed description
Type of Research: It is planned to be randomized, controlled and experimental. Place and Characteristics of the Research: The research will be carried out in the women health and diseases service and Gynecology polyclinics of Bezmialem Vakif University Faculty of Medicine Central Hospital.
Population and Sample of the Research:The sample size was determined as a minimum of 74 people in total using the G Power 3.1 method. The effect size was determined using the t test values in the reference study in which the scale was used with a similar patient group.
Criteria for Inclusion in the Study:Pregnant women who are between 6 and 14 weeks of gestation, aged between 20 and 40 years old, and have complaints of nausea and vomiting are eligible for the study. These participants should report their discomfort as 5 or above on the VAS scale. Additionally, they must not have been diagnosed with a high-risk pregnancy or any psychological disorders. Lastly, they must voluntarily agree to participate in the study.
Criteria for Exclusion from the Study: Exclusion criteria are the presence of coordination and language problems in the pregnant woman and her desire to leave the study at any time or not to participate.
Survey Scales Descriptive Information Form: The pregnancy information form, prepared in line with the literature review conducted by the researchers, includes socio-demographic (age of the pregnant woman, education and employment status, income level, family type and place of residence), obstetric (current gestational week and pregnancy history), psychosocial information. It consists of questions about social and medical history (pregnancy desire), whether there is a chronic disease) and VAS Scale. VAS is a measurement tool used to measure both pain intensity and pain relief, which is simple, effective and repeatable and requires minimal tools.
- Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24): its form specific to the pregnancy period that evaluates nausea and vomiting for the last 12 hours. It was later reported that it would be more appropriate to evaluate the last 24 hours for clinical use, as the last 12 hours sometimes include the sleep period in terms of nausea and vomiting in pregnant women. Thereupon, the Pregnancy-Unique Quantification of Emesis (PUQE-24) Scale was developed and evaluate the severity of pregnancy-specific nausea and vomiting in the last 24 hours. Its Turkish validity and reliability were conducted.
Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) consists of 3 questions:duration of nausea or stomach discomfort, number of vomiting episodes, and number of retching episodes. Answers to the questions are scored between 1 and 5 points. The total score of the scale is obtained by the sum of the scores of the answers given to the questions. The lowest possible score that can be obtained from the scale is 3 and the highest score is 15. If the total score obtained as a result of the PUQE-24 scoring system is 3-6, it is considered mild, 7-12 is considered moderate, and 13-15 is considered severe nausea and vomiting. The scale has no subdimensions. Cronbacha alpha value of the Turkish version of the scale is 0.75.
3.World Health Organization Quality of Life Scale: The WHOQOL-100 scale was developed with the participation of 15 centers from many countries. This scale allows cross-cultural comparisons. WHOQOL-100 was later abbreviated as WHOQOLBREF. WHOQOL-BREF consists of four sub-dimensions: physical domain, spiritual domain, social domain and environmental domain. The validity and reliability of the World Health Organization Quality of Life Scale 31 Short Form-Turkish Version (WHOQOL-BREF-TR) in Turkey was determined. WHOQOL-BREF-TR used in this study consists of 27 questions. For each question, there are options that can be scored between 1 and 5. The scale does not have a total score. The score range that can be obtained from each other sub-dimension is obtained by multiplying the arithmetic mean of that sub-dimension by 4. The score range that can be received for each sub-dimension is between 4-20. Increasing scores from the subscales indicate that the quality of life also increases
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- EXPERIMENTAL GROUP First Stage: Determining the groups by randomization method and filling out the data collection forms for the groups (pre-test). Second Stage: Training pregnant women in the control group on the management of standard hyperemesis gravidarum (training content will be prepared and opinions will be obtained from 3 experts in the field). For the intervention group, pregnant women were given a session with EFT (Average: 40-60 minutes) and a program was created for the pregnant woman to do affirmations in between depending on her condition (Positiveness with EFT strokes 3 times a day). Third Stage: After 15 days, it is planned to conduct post-tests for both groups and
| Arm | Type | Receives |
|---|---|---|
| EXPERİMENTAL GROUP | Experimental | Behavioral: EFT GROUPFirst Stage: Determining the groups by randomization method and filling out the data collection forms for the groups (pre-test). Second Stage: Training pregnant women in the control group on the management of standard hyperemesis gravidarum (training content will be prepared and opinions will be obtained from 3 experts in the field). For the intervention group, pregnant women were given a session with EFT (Average: 40-60 minutes) and a program was created for the pregnant woman to do affirmations in between depending on her condition (Positiveness with EFT strokes 3 times a day). Third Stage: After 15 days, it is planned to conduct post-tests for both groups and complete the study. In the final stage, pregnant women\'s questions will be answered, counseling will continue where deemed necessary, and prepared training booklets will be given to pregnant women |
| CONTROL GROUP | No intervention | –Pregnant women diagnosed with hyperemesis gravidarum (HG) who meet the inclusion criteria for the study will constitute the control group. Providing training to the control group only for HG management (training content will be prepared and opinions will be obtained from 3 experts in the field). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women between 6-14 weeks of pregnancy
- Pregnant women between the ages of 20-40
- Pregnant women with complaints of nausea and vomiting
- Pregnant women who report their discomfort as 5 or above on the vas scale
- Pregnant women who have not been diagnosed with risky pregnancy
Key exclusion criteria (3 listed)
- Coordination and language problems in the pregnant woman
- Wants to leave the study at any time
- Not wanting to participate in the study
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 |
|---|---|---|
| EFT GROUPAlso: emotıonal free technıcalOne times one pregnancy | Behavioural | EXPERİMENTAL GROUP |
Primary outcome
Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24)
Time frame: 3 months
The degree of reduction in the severity of nausea and vomiting. The PUQE-24 (Pregnancy-Unique Quantification of Emesis and Nausea) scale is used, where each question is scored between 1 and 5. The total score is the sum of these three questions. Minimum Score: 3 (each question scoring 1) Maximum Score: 15 (each question scoring 5) These scores are used to rate the severity of nausea and vomiting in pregnancy. Lower scores indicate milder symptoms, while higher scores indicate more severe symptoms.
1 secondary outcome
WHOQOL-BREF (World Health Organization Quality of Life - BREF)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
LECTURER contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFT GROUP in people with Hyperemesis Gravidarum and Pregnancy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 7 inclusion and 3 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 4 Jun 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 Turkey (Türkiye). 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 Merve MESEDUZU, LECTURER (800-555-5555, mervemeseduzu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) (time frame: 3 months). 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 4 Jun 2024.