- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07421063
The Effect of Emotional Freedom Technique on Parents' Anxiety Level: Newborn Hearing Screening
Emotional Freedom Technique for Parental Anxiety Regarding Newborn Hearing Screening
Newborn hearing screening (NHS) is a standard procedure that often triggers acute anxiety in parents. While Emotional Freedom Technique (EFT) has demonstrated efficacy in reducing psychological distress across various clinical settings, its specific application to parental anxiety during the neonatal screening period remains under-researched. This study addresses this gap by investigating the impact of a targeted EFT intervention on anxiety levels in mothers awaiting their newborns' first hearing tests.
The primary objective is to determine if a brief, 15-minute EFT session reduces maternal anxiety more effectively than a standard waiting period. Participants are randomly assigned to either an intervention group, where they perform a structured acupoint tapping sequence, or a control group that receives no active intervention. Anxiety is assessed using validated scales immediately before and after the 15-minute period to capture acute changes in distress. The researchers hypothesize that applying EFT regarding the procedure will significantly reduce parental anxiety levels compared to the non-intervention group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design and Randomization: This prospective, controlled experimental study utilizes a pretest-posttest design to evaluate the effects of the Emotional Freedom Technique (EFT) on parental anxiety. A total of 70 eligible parents will be recruited from the Newborn Hearing Screening (NHS) Units of two public hospitals. Participants will be assigned to either the EFT intervention group (n=35) or a non-intervention control group (n=35) using stratified block randomization with a 1:1 allocation ratio. Stratification is performed based on baseline state anxiety levels to ensure balanced distribution between the study arms.
Procedural Standardization and Participant Management: To maintain internal validity and ensure the stability of pre-procedural anxiety measurements, specific situational controls are implemented. Participants are excluded if acute situational triggers-such as neonatal crying or breastfeeding-occur immediately before or during the intervention period. To minimize external distractions and allow the participant to focus entirely on the protocol, relatives provide care for the neonates during the 30-35 minute study duration.
Intervention Protocols
- EFT Group: Participants receive a 15-minute guided session led by a certified practitioner. The session begins with the "Karate Chop" point setup, where the participant repeats a specific acceptance sentence three times. This is followed by sequential tapping (approximately seven times per point) on twelve designated acupoints: the beginning of the eyebrow, side of the eye, under the eye, under the nose, the chin, collarbone, under the armpit, thumb, index finger, middle finger, little finger, and the Karate Chop point. Multiple tapping rounds are completed within the 15-minute timeframe.
- Control Group: Participants undergo identical pre-test assessments but remain in a designated waiting area for 15 minutes without any active intervention, guidance, or therapeutic contact.
Data Collection and Measurement: Baseline assessments (Pre-tests) include a Parental Information Form, the Subjective Units of Distress Scale (SUDS), and the State-Trait Anxiety Inventory (STAI). Post-test assessments (SUDS and STAI) are administered to both groups immediately following the 15-minute intervention or waiting period. The STAI evaluates both situational (state) and general (trait) anxiety on a scale ranging from 20 to 80, while the SUDS provides a subjective distress rating from 0 to 10.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sümeyra Alan, PhD
- Phone Number: +90 5054568535
- Email: sumeyraalan@ibu.edu.tr
Study Locations
-
-
-
Bolu, Turkey (Türkiye), 14030
- Recruiting
- Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital, Newborn Hearing Screening Center
-
Contact:
- Sümeyra Alan, PhD
- Phone Number: +905054568535
- Email: sumeyraalan@ibu.edu.tr
-
Bolu, Turkey (Türkiye), 14030
- Recruiting
- Bolu Izzet Baysal State Hospital, Newborn Hearing Screening Center
-
Contact:
- Sümeyra Alan, PhD
- Phone Number: +905054568535
- Email: sumeyraalan@ibu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents of neonates who are undergoing the newborn hearing screening (NHS) for the first time.
- Ability to communicate effectively in the native language without language barriers.
- No prior experience or training in applying the Emotional Freedom Technique (EFT).
- Voluntary agreement to participate in the study and completion of the informed consent form.
Exclusion Criteria:
- Known history of diagnosed psychiatric disorders or epilepsy.
- Situations where the neonate is crying or being breastfed immediately prior to the intervention or during the assessment.
- The scheduled hearing screening procedure is initiated before the 30-35-minute study protocol is completed.
- Occurrence of any acute situational triggers or environmental distractions that may interfere with the stability of anxiety measurements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotional Freedom Technique Group
15-minute guided acupoint tapping session
|
15-minute guided acupoint tapping session
|
|
Other: Control Group
15-minute waiting period without active guidance
|
15-minute waiting period without active guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Inventory (STAI-S) Score
Time Frame: Baseline (Pre-test) and 15 minutes after the baseline (Post-test)
|
The STAI-S measures the current state of anxiety.
Scores range from 20 to 80, where higher scores indicate greater levels of anxiety.
|
Baseline (Pre-test) and 15 minutes after the baseline (Post-test)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Units of Distress Scale (SUDS)
Time Frame: Baseline (Pre-test) and 15 minutes after the baseline (Post-test).
|
A self-assessment scale for distress/anxiety.
Scores range from 0 (no distress) to 10 (extreme distress).
|
Baseline (Pre-test) and 15 minutes after the baseline (Post-test).
|
|
State-Trait Anxiety Inventory - Trait (STAI-T) Score
Time Frame: Baseline (Pre-test) and 15 minutes after the baseline (Post-test).
|
The STAI-T is a self-report scale used to measure an individual's general tendency to experience anxiety.
The scale consists of 20 items, with scores ranging from 20 to 80. Higher scores reflect a higher level of trait anxiety.
|
Baseline (Pre-test) and 15 minutes after the baseline (Post-test).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sümeyra Alan, PhD, Bolu Abant İzzet Baysal Üniversitesi
Publications and helpful links
General Publications
- Clond M. Emotional Freedom Techniques for Anxiety: A Systematic Review With Meta-analysis. J Nerv Ment Dis. 2016 May;204(5):388-95. doi: 10.1097/NMD.0000000000000483.
- Kim, D., Bae, H., & Chon Park, Y. (2008). Validity of the Subjective Units of Disturbance Scale in EMDR. Journal of EMDR Practice and Research, 2, 57 - 62.
- Oner N, Le Compte A. State-Trait Anxiety Inventory: Handbook. 2nd ed. Istanbul: Bogazici University Press; 1998.
- Wolpe J. Subjective Units of Distress Scale (SUDS). APA PsycTests. 1969.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-SBF-SA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
University of Colorado, BoulderEnrolling by invitationStress | Anxiety | Social AnxietyUnited States
Clinical Trials on Emotional Freedom Technique
-
Bingol UniversityActive, not recruitingCesarean Section | Preoperative AnxietyTurkey (Türkiye)
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
Soul Medicine InstituteCompletedStress Disorders, Post-TraumaticUnited States
-
Ataturk UniversityNot yet recruiting
-
Uşak UniversityRecruiting
-
Bitlis Eren UniversityCompletedAnxiety | Compliance, Patient | Complication,Postoperative | Limb Injury | Complication Diabetic | Limb IschemiaTurkey (Türkiye)
-
Inonu UniversityCompletedAnxiety | Nausea Gravidarum | Emotion Regulation | Vomiting of PregnancyTurkey
-
Saglik Bilimleri UniversitesiNot yet recruitingPreoperative Anxiety | Thyroid Surgery | Fear and AnxietyTurkey (Türkiye)
-
Marmara UniversityActive, not recruitingAnxiety | Nursing Caries | EFTsTurkey
-
Istanbul Saglik Bilimleri UniversityCompleted