NCT05337852

Brief Summary

One of the most common discomforts in early pregnancy is nausea and vomiting. Although its etiology is not known exactly, it affects an average of 50-90% of pregnant women. The severity of nausea-vomiting can vary from person to person, as well as in different pregnancies of the woman. The severity of nausea-vomiting is affected by hormonal, psychological and social factors. Adaptation to pregnancy, spouse relations, future anxiety and social support perception in nausea and vomiting experienced during early pregnancy affect women negatively and cause anxiety. The severity of nausea and vomiting also increases due to anxiety. As the severity of nausea-vomiting increases, the search for solutions to this situation and their applications to health institutions increase. Many non-pharmacological methods (respiratory exercises, acupuncture, acupressure, etc.) are used in treatment, as well as hydration, rest and pharmacological agents. One of these methods is the emotional liberation technique, which is included in cognitive behavioral therapies. This method basically treats the person physiologically and psychologically as a whole, similar to other cognitive behavioral therapies, unless there is a physiological disorder. It is aimed to reach a solution by raising awareness for the emotion felt, avoiding negative emotions and focusing on affirmations to replace them. Emotional liberation technique is an easy-to-apply and fast-solving technique in cases recorded in the subconscious with negative emotions and in the treatment of stress disorders in general. No use of emotional liberation technique has been found in the literature for the severity of nausea-vomiting and anxiety experienced during early pregnancy. Therefore, it is thought that this study will contribute to the literature. In addition, it is thought that this method will enrich midwifery interventions as a non-pharmacological method applied to pregnant women in the treatment of nausea-vomiting and anxiety, because this method is fast and practical, and the result is easy to reach. The aim of this study is to determine the effect of emotional liberation technique applied during early pregnancy on nausea and vomiting severity and anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 9, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

March 9, 2022

Last Update Submit

August 23, 2023

Conditions

Keywords

NauseaVomitingAnxietyEmotional Freedom TechniquePregnancy

Outcome Measures

Primary Outcomes (1)

  • Subjective Units of Experience- (SUE)

    The negative 10 feel the greatest pain, disappointment, fear, stress, sadness, or discomfort imaginable. When it reaches Positive 10, the client feels very different and wonderful. The meanings of the ratings in this range change gradually. The scale has no cutoff score. It is interpreted according to the mean of the scores and its relevance to other variables.

    Each participant will be evaluated for 1 week.

Secondary Outcomes (3)

  • Descriptive Data

    It will be obtained in 1 month at the beginning of the research.

  • Pregnancy Unique Quantification of Emesis and Nausea- (PUQE)

    The time frame; pregnant women between 6 and 16 weeks included in the study will be evaluated for 4 weeks. It will take an average of 1 month to obtain the data. Measured PUQE scale data will be reported within 6 weeks at the end of the study.

  • Pregnancy-Related Anxiety Questionnaire-2 (PRAQ-2)

    The time frame; pregnant women between 6 and 16 weeks included in the study will be evaluated for 4 weeks. It will take an average of 1 month to obtain the data. Measured PRAQ-R2 scale data will be reported within 6 weeks at the end of the study.

Study Arms (2)

Experimental group

EXPERIMENTAL

To the pregnant women in the experimental group; * Emotional freedom technique was applied online with the researcher twice a week. * PUQE, PRAQ-2 tests will be applied before the intervention, * SUE and PUQE will be applied before and after each session, * After 2 sessions, post-test data will be obtained with PUQE, SUE, PRAQ-2.

Other: Emotional Freedom Technique

Control group

NO INTERVENTION

* After each intervention applied to the experimental group, SUE and PUQE will be applied to the control group over the phone, simultaneously. * After 1 week, post-test data will be obtained with PUQE, SUE, PRAQ-2.

Interventions

To the pregnant women in the experimental group; Emotional freedom technique was applied online with the researcher twice a week. The "release protocol of EFT" was taught to the participants and it was applied between the interviews made by the researcher. Whether the participant did the application or not was confirmed by phone and a homework schedule was used for smooth follow-up. * PUQE, PRAQ-2 tests will be applied before the intervention, * SUE and PUQE will be applied before and after each session, * After 2 sessions, post-test data will be obtained with PUQE, SUE, PRAQ-2.

Experimental group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Not having a verbal communication problem,
  • th of pregnancy be in the week
  • Not having a psychiatric disorder
  • Having a single, viable fetus
  • Absence of a fetal congenital malformation
  • Not having any disease other than pregnancy that will cause nausea and vomiting

You may not qualify if:

  • Diagnosing a risky pregnancy during the research process,
  • Asking to leave the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Health Sciences Pregnant Education Class

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

  • Guven Santur S, Ozsahin Z. The Effects of Emotional Freedom Techniques Implemented During Early Pregnancy on Nausea-Vomiting Severity and Anxiety: A Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):858-868. doi: 10.1089/jicm.2023.0586. Epub 2024 Mar 27.

MeSH Terms

Conditions

Anxiety DisordersEmotional RegulationNauseaVomiting

Condition Hierarchy (Ancestors)

Mental DisordersSelf-ControlSocial BehaviorBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zeliha OZSAHİN

    https://www.inonu.edu.tr/akademik/zeliha.ozsahin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The randomized experiment was designed as a control study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 20, 2022

Study Start

April 1, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Data will be obtained with Personal Information Form, Subjective Experience Units (SUE), Pregnancy Unique Quantification of Emesis (PUQE) and Pregnancy-Related Anxiety Questionnaire - R2 (PRAQ-R2).

Locations