Emotion RegulationNCT06323083
The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy in Nursing Students
A study testing Emotional Freedom Technique in people with Emotion Regulation and Stress, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of Emotional Freedom Technique (EFT) on perceived stress and general self-efficacy in obstetrics and gynecology nursing lesson in undergraduate nursing students with fear of birth. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Stress, Self Efficacy
- What is being tested?
- Emotional Freedom Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2022to 30 Jun 2023
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female students who were taking the Obstetrics and Gynecology Nursing course at the Faculty of Nursing, who volunteered to participate in the study, and who thought they had a fear of childbirth were included in the study.
Who cannot join
- Female students who did not take the Obstetrics and Gynecology Nursing course at the Faculty of Nursing, did not volunteer to participate in the study, and did not think they had a fear of childbirth were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy About Obstetrics and Gynecology Nursing Lesson in Undergraduate Nursing Students With Fear of Birth
The study was conducted to determine the effect of Emotional Freedom Technique (EFT) on perceived stress and general self-efficacy in obstetrics and gynecology nursing lesson in undergraduate nursing students with fear of birth.
The samples were applied to undergraduate nursing students satisfying the research criteria in a state university nursing faculty in Konya at November 2022.
Read the detailed description
The study was designed to be randomly controlled. Block randomization method was used to determine the intervention and control groups. Randomization was done by a biostatistician outside the researcher. 50 nursing students were randomly assigned to the intervention and control groups. The study was carried out in three stages with three EFT applications, applied for approximately 20-30 minutes, at 7-day intervals. In the first stage, students who met the inclusion criteria were identified by interviewing students who thought they had a fear of childbirth. After informed consent was obtained from the students and pretest data were collected, they were randomly assigned to intervention and control groups. EFT application was applied to those in the intervention group. No intervention was made for the control group. Data was collected twice for the intervention group, before the first EFT application (pretest) and after the last EFT application (posttest). The control group was also tested at the first interview and again 3 weeks later. The applications were carried out face to face with the students as a group. For the collection of research data, "Descriptive Information Form", "General Self-Efficacy (GSE) Scale", "Perceived Stress Scale" and "The Subjective Units of Distress (SUD) Scale" were used.
- Conditions
- Emotion Regulation, Stress, Self Efficacy
- Being tested
- Emotional Freedom Technique
- Keywords
- Emotion Regulation, Stress, Self Efficacy, Nursing Student
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom TechniqueOther
Emotional freedom techniques is a psychophysiological intervention that combines psychological methods from traditional therapies with somatic stimulation. EFT involves tapping acupuncture points to desensitize negative emotions by focusing on the emotion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Emotional Freedom Technique (EFT) application was applied to those in the intervention group.
The study was carried out in three stages with three EFT applications, applied for approximately 20-30 minutes, at 7-day intervals. In the first stage, students who met the inclusion criteria were identified by interviewing students who thought they had a fear of childbirth. Receives: Other: Emotional Freedom Technique |
| Control group | No intervention | The control group was also tested at the first interview and again 3 weeks later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Self-Efficacy Scale
The scale consists of 10 items. It is scored between 1-4 and the lowest 10 and the highest 40 points can be obtained.
Measured: Change from The General Self-Efficacy Scale at three weeks
Perceived Stress Scale
The scale consists of 14 items. It is scored between 0-4 and the lowest 0 and the highest 56 points can be obtained.
Measured: Change from The Perceived Stress Scale at three weeks
The Subjective Units of Distress Scale
It is an 11-point scale commonly used as a subjective verbal rating of discomfort, where 0 indicates absence of discomfort and 10 indicates that it is intolerable.
Measured: Change from The Subjective Units of Distress Scale at three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start7 Nov 2022
- Primary completion28 Nov 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed to be randomly controlled.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Esra Meram, Selcuk University
- Investigators
- Halime Esra Meram, PhD, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323083
- Sponsor's protocol ID
- 006
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy About Obstetrics and Gynecology Nursing Lesson in Undergraduate Nursing Students With Fear of Birth
- ClinicalTrials.gov ID
- NCT06323083
- Acronym / sponsor ID
- 006
- Conditions
- Emotion Regulation, Stress, Self Efficacy
- Keywords
- Emotion Regulation, Stress, Self Efficacy, Nursing Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Mar 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 study was conducted to determine the effect of Emotional Freedom Technique (EFT) on perceived stress and general self-efficacy in obstetrics and gynecology nursing lesson in undergraduate nursing students with fear of birth.
The samples were applied to undergraduate nursing students satisfying the research criteria in a state university nursing faculty in Konya at November 2022.
Detailed description
The study was designed to be randomly controlled. Block randomization method was used to determine the intervention and control groups. Randomization was done by a biostatistician outside the researcher. 50 nursing students were randomly assigned to the intervention and control groups. The study was carried out in three stages with three EFT applications, applied for approximately 20-30 minutes, at 7-day intervals. In the first stage, students who met the inclusion criteria were identified by interviewing students who thought they had a fear of childbirth. After informed consent was obtained from the students and pretest data were collected, they were randomly assigned to intervention and control groups. EFT application was applied to those in the intervention group. No intervention was made for the control group. Data was collected twice for the intervention group, before the first EFT application (pretest) and after the last EFT application (posttest). The control group was also tested at the first interview and again 3 weeks later. The applications were carried out face to face with the students as a group. For the collection of research data, "Descriptive Information Form", "General Self-Efficacy (GSE) Scale", "Perceived Stress Scale" and "The Subjective Units of Distress (SUD) Scale" were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was designed to be randomly controlled.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Emotional Freedom TechniqueEmotional Freedom Technique (EFT) application was applied to those in the intervention group. The study was carried out in three stages with three EFT applications, applied for approximately 20-30 minutes, at 7-day intervals. In the first stage, students who met the inclusion criteria were identified by interviewing students who thought they had a fear of childbirth. |
| Control group | No intervention | –The control group was also tested at the first interview and again 3 weeks later. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female students who were taking the Obstetrics and Gynecology Nursing course at the Faculty of Nursing, who volunteered to participate in the study, and who thought they had a fear of childbirth were included in the study.
Key exclusion criteria (1 listed)
- Female students who did not take the Obstetrics and Gynecology Nursing course at the Faculty of Nursing, did not volunteer to participate in the study, and did not think they had a fear of childbirth were not included 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 |
|---|---|---|
| Emotional Freedom TechniqueEmotional freedom techniques is a psychophysiological intervention that combines psychological methods from traditional therapies with somatic stimulation. EFT involves tapping acupuncture points to desensitize negative emotions by focusing on the emotion. | Other | Intervention group |
Primary outcome
General Self-Efficacy Scale
Time frame: Change from The General Self-Efficacy Scale at three weeks
The scale consists of 10 items. It is scored between 1-4 and the lowest 10 and the highest 40 points can be obtained.
Perceived Stress Scale
Time frame: Change from The Perceived Stress Scale at three weeks
The scale consists of 14 items. It is scored between 0-4 and the lowest 0 and the highest 56 points can be obtained.
The Subjective Units of Distress Scale
Time frame: Change from The Subjective Units of Distress Scale at three weeks
It is an 11-point scale commonly used as a subjective verbal rating of discomfort, where 0 indicates absence of discomfort and 10 indicates that it is intolerable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
Related trials for Emotion Regulation
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruitingPhase 2
Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism
Autism in Children, Autistic Disorder in Children and Adolescents
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
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.
Halime Esra Meram, PhD study director
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Freedom Technique in people with Emotion Regulation and Stress, run by Selcuk 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self-Efficacy Scale (time frame: Change from The General Self-Efficacy Scale at three weeks). The study lists 3 primary outcomes in all. 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 21 Mar 2024.