NCT07421063

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

February 12, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Emotional Freedom TechniqueParental HealthTappingComplementary TherapiesNeonatal ScreeningAcupressureEFTNewborn Hearing ScreeningAnxiety, Procedure-Related

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Inventory (STAI-S) Score

    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 Outcomes (2)

  • Subjective Units of Distress Scale (SUDS)

    Baseline (Pre-test) and 15 minutes after the baseline (Post-test).

  • State-Trait Anxiety Inventory - Trait (STAI-T) Score

    Baseline (Pre-test) and 15 minutes after the baseline (Post-test).

Study Arms (2)

Emotional Freedom Technique Group

EXPERIMENTAL

15-minute guided acupoint tapping session

Behavioral: Emotional Freedom Technique

Control Group

OTHER

15-minute waiting period without active guidance

Other: No intervention

Interventions

15-minute guided acupoint tapping session

Emotional Freedom Technique Group

15-minute waiting period without active guidance

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital, Newborn Hearing Screening Center

Bolu, 14030, Turkey (Türkiye)

Location

Bolu Izzet Baysal State Hospital, Newborn Hearing Screening Center

Bolu, 14030, Turkey (Türkiye)

Location

Related Publications (4)

  • Wolpe J. Subjective Units of Distress Scale (SUDS). APA PsycTests. 1969.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26894319BACKGROUND
  • Oner N, Le Compte A. State-Trait Anxiety Inventory: Handbook. 2nd ed. Istanbul: Bogazici University Press; 1998.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Sümeyra Alan, PhD

    Bolu Abant İzzet Baysal Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

March 31, 2026

Primary Completion

June 24, 2026

Study Completion

June 24, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this study, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal. The primary objective is to allow for secondary analyses that align with the original research goals. All data sharing will be conducted in strict accordance with the participant confidentiality protections outlined in the Informed Consent Form. A formal Data Use Agreement (DUA) must be signed before any data transfer occurs.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be made available beginning 6 months after the publication of the primary results and will remain accessible for a period of 3 years.
Access Criteria
Data access requests should be submitted via email to \[sumeyraalan@ibu.edu.tr\]. Proposals will be reviewed for scientific merit. Requestors must demonstrate that they have obtained necessary institutional ethical approvals and must agree to use the data only for the purposes specified in their approved proposal.

Locations