Emotional Freedom Technique in Early Pregnancy

NCT ID: NCT05337852

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pregnancy is a process that causes physiological, psychological and social changes in the female body. Pregnancy period consists of three different trimesters, divided into three-month periods. In each trimester, different physiological and psychological processes specific to pregnancy are experienced, and different approaches specific to these processes are required for the general well-being of the woman and the healthy progression of the pregnancy.

Nausea-vomiting is one of the most common problems that occur during early pregnancy. Although its etiology is not known exactly, 50-90% of pregnant women are affected by this problem. It is thought that pregnancy hormones, gastrointestinal system disorders, hyperthyroidism, nutritional disorders and psychological factors cause nausea and vomiting or increase nausea-vomiting during early pregnancy. Nausea-vomiting in pregnancy; It is also called morning sickness, emesis gravidarum, pregnancy sickness. Nausea-vomiting during pregnancy starts on average in the 5th week of pregnancy, 8-12th week. It reaches its highest levels in the 16th weeks and is expected to decrease and disappear from the 16th week. It has been stated that the severity of nausea-vomiting during pregnancy varies from person to person, differs in each pregnancy of the person, and continues throughout the day, although it is often at the beginning of the day. Although many studies in this field focus on factors such as physiological, psychological, social and genetic, the common belief is that nausea and vomiting are based on psychological factors.

Early pregnancy symptoms such as nausea and changes in the breasts pave the way for emotional changes. In emotional changes, women generally do not feel joy for the baby during this period, but they often experience opposite feelings by wanting their pregnancy to be known by everyone. Stress and emotional changes arising from these contrasts create anxiety processes. Anxiety is defined as a disorder characterized by fear, restlessness, restlessness, tension, and changes such as sweating, dyspnea, and sleep problems experienced for an unknown or unidentified reason. Anxiety disorders are more common in women than men, and anxiety disorders can be seen in 30% of women in their reproductive years. Studies have shown that the rate of anxiety disorders during pregnancy varies between 6% and 30%. Among the causes of anxiety in pregnancy; educational status, spousal relations, psycho-social support, family problems, presence of violence, and concerns about the baby. As a result of all these reasons, pregnancy hormones and neuroendocrine system are affected and cause nausea and vomiting. In addition, it is emphasized that unwanted pregnancy, perceived stress, acceptance of pregnancy are among the most important psychosocial factors that cause nausea and vomiting.

Pregnant women with nausea-vomiting may have feelings of isolation, loneliness, guilt, may consider terminating their pregnancy, and may experience anxiety about the effect of nausea-vomiting on their baby. Pregnant women experience anxiety for reasons such as not being able to concentrate on their baby, worrying about the future, adapting to pregnancy and thinking only about their own health, and the need for intervention for these parameters is increasing.

In psychoanalytic thought, nausea-vomiting during pregnancy is defined as a defense mechanism developed against unidentified discontent and the way the person expresses this situation. In order to change this discontent and the way of self-expression of the person, besides many psychotherapy methods, the emotional liberation technique, which is quick and easy to apply, and aims to reach the result in a short way by working on emotion-based, can have positive effects. Emotional liberation; It is an energy psychology technique that aims to free from negative emotions, clearing negative emotions, experiences, traumas and fears from the past and regulating the energy flow.

Energy psychology, which has thousands of years of history in eastern cultures and has been used in the treatment of psychological problems in the West for the last 40 years, is not that human consists of independent parts; It is a new method based on the holistic approach, which is believed to have the knowledge of the whole of each part. According to energy psychology, it is in harmony with human physiology, mental processes, emotions and behaviors. Along with these processes, human is considered as a whole, including the environment and culture. It hypothesizes that psychological disorders and other health conditions are associated with disturbances in the body's electrical energies and these energy fields, as well as congestion or disruption.

For this reason, emotional liberation technique, which is a non-pharmacological method, can be a practical method for psychological-based nausea-vomiting and anxiety by accepting the physiology, psychology, emotions and social environment of the pregnant as a whole.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nausea Gravidarum Anxiety Emotion Regulation Vomiting of Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomized experiment was designed as a control study.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

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.

Group Type EXPERIMENTAL

Emotional Freedom Technique

Intervention Type OTHER

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.

Control group

* 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Emotional Freedom Technique

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Not having a verbal communication problem,
* 6-12th 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

Exclusion Criteria

* Diagnosing a risky pregnancy during the research process,
* Asking to leave the research.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sinem GUVEN Santur

Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zeliha OZSAHİN

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inonu University Faculty of Health Sciences Pregnant Education Class

Malatya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38531058 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Inonu Universty

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

FETAL MOVEMENT COUNTING
NCT05361265 COMPLETED NA