- 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 maternal 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 were randomly assigned to either an intervention group, where they perform a structured acupoint tapping sequence, or a control group that received no active intervention. Anxiety was assessed using validated scales immediately before and after the 15-minute period to capture acute changes in distress. Due to clinical environment conditions and hospital accompaniment patterns, the study was completed with a final sample of 70 mothers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design and Randomization: This prospective, controlled experimental study utilized a pretest-posttest design to evaluate the effects of the Emotional Freedom Technique (EFT) on maternal anxiety. A total of 72 eligible mothers were recruited from the Newborn Hearing Screening (NHS) Units of two public hospitals. Participants were assigned to either the EFT intervention group (n=36) or a non-intervention control group (n=34) using stratified block randomization based on hospital site and baseline state anxiety levels.
Procedural Standardization and Participant Management: To maintain internal validity and ensure the stability of pre-procedural anxiety measurements, specific situational controls were implemented. Participants were excluded if acute situational triggers-such as neonatal crying or breastfeeding-occurred immediately before or during the intervention period. In accordance with this criterion, two participants were excluded from the study due to persistent neonatal crying during the session. To minimize external distractions and allow the participant to focus entirely on the protocol, relatives provided care for the neonates during the 30-35 minute study duration.
Intervention Protocols:
- EFT Group: Participants received a 15-minute guided session led by a certified practitioner. The session began with the "Karate Chop" point setup, where the participant repeated a specific acceptance sentence three times. This was 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 were completed within the 15-minute timeframe.
- Control Group: Participants underwent identical pre-test assessments but remained in a designated waiting area for 15 minutes without any active intervention, guidance, or therapeutic contact.
Data Collection and Measurement: Baseline assessments (Pre-tests) included a Parental Information Form, the Subjective Units of Distress Scale (SUDS), and the State-Trait Anxiety Inventory (STAI). Post-test assessments (SUDS and STAI) were administered to both groups immediately following the 15-minute intervention or waiting period. The STAI evaluated both situational (state) and general (trait) anxiety on a scale ranging from 20 to 80, while the SUDS provided a subjective distress rating from 0 to 10.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bolu, Turkey (Türkiye), 14030
- Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital, Newborn Hearing Screening Center
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Bolu, Turkey (Türkiye), 14030
- Bolu Izzet Baysal State Hospital, Newborn Hearing Screening Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mothers 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 (Actual)
Study Completion (Actual)
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
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