NCT06442813

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

January 12, 2024

Last Update Submit

May 28, 2024

Conditions

Keywords

hyperemesis gravidarumquality lifepregnancyEmotional Freedom Techniques

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

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

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).

Interventions

EFT GROUPBEHAVIORAL

One times one pregnancy

Also known as: emotıonal free technıcal
EXPERİMENTAL GROUP

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Merve MESEDUZU, LECTURER

CONTACT

LECTURER

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
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

Locations