The Effect of Emotional Freedom Technique Applied to High-Risk Pregnant Women on Anxiety and Postpartum Depression: A Randomized Controlled Trial
Phase: NA
Conditions: High Risk Pregnancy
Sponsor: Mersin University

Study Protocol 
Study Title: The Effect of Emotional Freedom Technique Applied to High-Risk Pregnant 
Women on Anxiety and Postpartum Depression: A Randomized Controlled Trial 
ClinicalTrials.gov Identifier: 2024/99 
Document Date: October 30, 2025 
Sponsor / Institution: Mersin Universty 
Principal Investigator: [Meltem AYDIN BEŞEN] 
Study Design 
This study aims to evaluate the effect of the Emotional Freedom Technique (EFT) applied in 
the preoperative period on anxiety and postpartum depression (PPD) in high-risk pregnant 
women scheduled for cesarean section. 
The study was conducted between March and September 2024 at a City Hospital and 
followed a single-blind randomized controlled design. 
Participants 
The sample consisted of high-risk pregnant women according to the Ministry of Health Risk 
Assessment Form who met the inclusion criteria. Inclusion criteria included: women 
scheduled for C-section surgery, gestational age over 36 weeks, a State-Trait Anxiety Scale 
(STAI-S) mean score of 37 or higher, and voluntary consent to participate. The sample size 
was calculated using pilot study data. Based on the analysis using the (STAI-S) mean scores, 
it was assumed that a statistically significant difference of at least 5 points would occur 
between groups post-intervention. The study was planned with a 95% confidence level 
(α=0.05) and 80% statistical power (1-β=0.80), requiring at least 18 participants per group. 
To meet parametric test assumptions, 30 participants were assigned to each group. 
Randomization and Blinding 
Randomization was performed by a researcher not involved in the intervention using an 
online randomization tool (randomizer.org). Group assignments were sealed in opaque 
envelopes and delivered to the intervening researcher to ensure confidentiality. The study 
was conducted in a single-blind design, with participants unaware of their group 
assignments. 
Data Collection Instruments 
1. Introductory Information Form: Focuses on socio-demographic and obstetric 
characteristics. 
2. STAI-S: Developed by Spielberger et al. (1970) and adapted to Turkish by Öner and Le 
Compte (1983). It consists of 20 items scored on a 4-point Likert-type scale (range 20–80). 
Higher scores indicate greater anxiety. Cronbach’s alpha = 0.80. 
3. Edinburgh Postnatal Depression Scale (EPDS): Developed by Cox et al. (1987) and 

adapted to Turkish by Aydın et al. (2004). It consists of 10 items scored from 0–3, with 
scores ≥13 indicating risk of PPD. Cronbach’s alpha = 0.88. 
4. Subjective Units of Emotion (SUE) Scale: Assesses emotional intensity after EFT sessions 
(−10 to +10). 
Intervention 
Participants were randomized into two groups: EFT Group and Standard Care Group. 
 
EFT Group: Pregnant women meeting inclusion criteria were informed about the study and 
gave written consent. The introductory form and SUE scale were administered. EFT points 
were demonstrated, and trial applications were conducted. Sessions continued until 
participants reached +7 on the SUE scale. STAI-S was re-administered one hour before 
surgery. Postpartum, women were instructed to use EFT independently, and the EPDS was 
administered via telephone on postpartum day 21. 
 
EFT Application Stages: 
a) Symptom Severity: Initial SUE scale assessment. 
b) Engagement with the Problem: Focus on emotion and problem. 
c) Breathing and Acceptance: Deep breathing with an acceptance statement (“Even though I 
feel fear, I completely accept myself.”). 
d) Tapping: Light tapping on 14 acupressure points while repeating the acceptance 
statement. 
e) Interim Evaluation: SUE re-applied; repeat sessions if necessary. 
f) Affirmation: When SUE reaches 0, positive affirmations are added (“I am releasing my 
worry; I am safe; I am peacefully welcoming my baby.”). 
g) Termination: Process ends when positive energy reaches +7. 
 
Standard Care Group: Pregnant women in the control group received standard preoperative 
care. STAI-S was re-administered in the last hour before C-section, and EPDS was applied 
via telephone on postpartum day 21. 
Statistical Analysis 
Data were analyzed using statistical software. The Shapiro–Wilk test and skewness–
kurtosis were used to assess distribution normality. Normally distributed data were 
analyzed with Independent Samples T-test. One-Way ANOVA tested three or more 
variables, with Bonferroni and Tukey post hoc tests for pairwise comparisons. Paired 
Samples T-test was used to compare pre- and post-test data within groups. Pearson 
correlation analyzed relationships between continuous variables. Significance level was set 
at p < 0.05, and Bonferroni-adjusted significance at p < 0.01. 
Ethical Considerations 
Ethical approval was obtained from the university ethics committee (Approval No: 
2024/299). Participants were informed about the purpose of the study, and written 
informed consent was obtained from all who voluntarily agreed to participate.