Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
PREGNANCY
2 other identifiers
interventional
74
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedJune 4, 2024
May 1, 2024
2 months
January 12, 2024
May 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
WHOQOL-BREF (World Health Organization Quality of Life - BREF)
3 months
Study Arms (2)
EXPERİMENTAL GROUP
EXPERIMENTALFirst 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 INTERVENTIONPregnant 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Coordination and language problems in the pregnant woman
- Wants to leave the study at any time
- Not wanting to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif Universty
Istanbul, Fatih, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- LECTURER
Study Record Dates
First Submitted
January 12, 2024
First Posted
June 4, 2024
Study Start
June 10, 2024
Primary Completion
August 20, 2024
Study Completion
August 30, 2024
Last Updated
June 4, 2024
Record last verified: 2024-05