AnxietyNCT07421063
The Effect of Emotional Freedom Technique on Parents' Anxiety Level: Newborn Hearing Screening
A study testing Emotional Freedom Technique in people with Anxiety and Parental Anxiety, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Parental Anxiety, Maternal Anxiety
- What is being tested?
- Emotional Freedom Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 31 Mar 2026to 24 Jun 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital, Newborn Hearing Screening Center
Bolu, 14030
Bolu Izzet Baysal State Hospital, Newborn Hearing Screening Center
Bolu, 14030
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Parental Anxiety, Maternal Anxiety
- Being tested
- Emotional Freedom Technique, No intervention
- Keywords
- Emotional Freedom Technique, Parental Health, Tapping, Complementary Therapies, Neonatal Screening, Acupressure, EFT, Newborn Hearing Screening, Anxiety, Procedure-Related
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom TechniqueBehavioural
15-minute guided acupoint tapping session
No interventionOther
15-minute waiting period without active guidance
| Study group | Role | What they receive |
|---|---|---|
| Emotional Freedom Technique Group | Experimental | 15-minute guided acupoint tapping session Receives: Behavioral: Emotional Freedom Technique |
| Control Group | Other | 15-minute waiting period without active guidance Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Pre-test) and 15 minutes after the baseline (Post-test)
Secondary outcomes (2)
Subjective Units of Distress Scale (SUDS)
A self-assessment scale for distress/anxiety. Scores range from 0 (no distress) to 10 (extreme distress).
Measured: Baseline (Pre-test) and 15 minutes after the baseline (Post-test).
State-Trait Anxiety Inventory - Trait (STAI-T) Score
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.
Measured: Baseline (Pre-test) and 15 minutes after the baseline (Post-test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start31 Mar 2026
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyra ALAN, Abant Izzet Baysal University
- Investigators
- Sümeyra Alan, PhD, Principal investigator, Bolu Abant İzzet Baysal Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421063
- Sponsor's protocol ID
- AIBU-SBF-SA-01
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Wolpe J. Subjective Units of Distress Scale (SUDS). APA PsycTests. 1969.
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.
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.
PubMed 26894319Oner N, Le Compte A. State-Trait Anxiety Inventory: Handbook. 2nd ed. Istanbul: Bogazici University Press; 1998.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Freedom Technique for Parental Anxiety Regarding Newborn Hearing Screening
- ClinicalTrials.gov ID
- NCT07421063
- Acronym / sponsor ID
- AIBU-SBF-SA-01
- Conditions
- Anxiety, Parental Anxiety, Maternal Anxiety
- Keywords
- Emotional Freedom Technique, Parental Health, Tapping, Complementary Therapies, Neonatal Screening, Acupressure, EFT, Newborn Hearing Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 19 Feb 2026 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Freedom Technique Group | Experimental | Behavioral: Emotional Freedom Technique15-minute guided acupoint tapping session |
| Control Group | Other | Other: No intervention15-minute waiting period without active guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 Technique15-minute guided acupoint tapping session | Behavioural | Emotional Freedom Technique Group |
| No intervention15-minute waiting period without active guidance | Other | Control Group |
Primary outcome
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.
2 secondary outcomes
Subjective Units of Distress Scale (SUDS)
Time frame: 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).
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 30 Jul 2026.
- BackgroundWolpe J. Subjective Units of Distress Scale (SUDS). APA PsycTests. 1969.
- BackgroundKim, 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: PubMed 26894319Clond 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.
- BackgroundOner N, Le Compte A. State-Trait Anxiety Inventory: Handbook. 2nd ed. Istanbul: Bogazici University Press; 1998.
- Individual participant dataSharing planned: Yes. 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.
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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.
Sümeyra Alan, PhD principal investigator
Bolu Abant İzzet Baysal Üniversitesi
2 sites 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 Anxiety and Parental Anxiety, run by Abant Izzet Baysal University at 2 sites 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 4 inclusion and 4 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
State Anxiety Inventory (STAI-S) Score (time frame: Baseline (Pre-test) and 15 minutes after the baseline (Post-test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07421063, which also lists 4 linked publications.
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 30 Jul 2026.