Clinical trial NCT06999564: Effects of EFT on Postpartum Safety Perception, Anxiety, and Postoperative Pain After Cesarean Section
Official title: The Effect of Eft applıed Before Cesarean sectıon on Postpartum feelıngs of Safety, anxıety and postoperatıve paın: RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Management
Anxiety
Keywords: caesarean section
anxiety
sense of course
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel randomized controlled trial on 60 primiparous women with cesarean section pain randomly allocated to EFT and control groups. The study was approved by the Ethics Committee of KTO Karatay University Faculty of Medicine. In addition, the protocol of this study was registered in the Clinical Trials Register. All participants gave written informed consent before data collection. Women were included according to the following criteria: at least primary school graduate, primiparous, planned cesarean section, and postoperative pain of 4 or more according to VAS. Women with chronic diseases such as heart disease, high blood pressure and diabetes, history of miscarriage, placenta previa, mental illness in the past year, use of psychoactive drugs, drug addiction, smoking, and pregnancy complications such as pre-eclampsia, bleeding, intrauterine death and preterm delivery were excluded.
Primary purpose: PREVENTION

Brief summary: This study is a parallel randomized controlled trial on 60 primiparous women with cesarean section pain randomly allocated to EFT and control groups. The study was approved by the Ethics Committee of KTO Karatay University Faculty of Medicine. In addition, the protocol of this study was registered in the Clinical Trials Register. All participants gave written informed consent before data collection. Women were included according to the following criteria: at least primary school graduate, primiparous, planned cesarean section, and postoperative pain of 4 or more according to VAS. Women with chronic diseases such as heart disease, high blood pressure and diabetes, history of miscarriage, placenta previa, mental illness in the past year, use of psychoactive drugs, drug addiction, smoking, and pregnancy complications such as pre-eclampsia, bleeding, intrauterine death and preterm delivery were excluded. Data collection started in April 2025 and was completed in June 2025.

Detailed description: Caesarean section is a surgical operation used when vaginal delivery is risky for the mother and fetus and can have both long and short-term effects on maternal and infant health. It is known that caesarean sections do not have a proven positive effect on mother-baby health, but may have negative consequences. After cesarean section, women may experience various problems such as inability to perform activities of daily living, breastfeeding problems, inability to actively take care of the newborn, decreased postpartum comfort, anxiety, depression, insomnia and pain.

Postoperative pain, one of the most common complications of cesarean section, plays an important role in ensuring skin-to-skin contact, establishing mother-baby bonding, initiating breastfeeding, the mother\&#39;s recovery process and maternal-infant health. In addition, women may experience various levels of stress, anxiety and insecurity after cesarean section. Factors such as spousal support, presence of social support resources, attitudes of health personnel, antenatal education about the postpartum period, general well-being of mother and baby, stress, anxiety, depression, mode of delivery, perception of delivery, birth experience, breastfeeding problems, early discharge are factors affecting mothers\&#39; sense of security in the postpartum period. Failure to provide a sense of security after birth increases the risk of anxiety and depression in the following periods. Factors that increase anxiety in women after cesarean section include surgical operation, prolonged transition to oral feeding, late mobilization, risk of infection, delayed mother-infant interaction and milk release.

Early detection of post-cesarean anxiety and postpartum sense of security and taking measures to address these conditions can improve the mother\&#39;s quality of life, reduce anxiety and worry, and contribute to the effective and efficient maintenance of the mother-infant relationship. Reducing postoperative pain is also of great importance in terms of preventing physical complications and chronic pain, relieving depression, improving the quality of life of the individual, providing postpartum comfort and supporting effective breastfeeding. The side effects of pharmacologic methods used to improve postoperative pain and comfort after cesarean section and the inadequacy of these methods have increased the interest in non-pharmacologic approaches. Nonpharmacological techniques include diaphragmatic breathing exercises, Lamaze methods, visualization, meditation, acupuncture, acupressure, reflexology, massage, hypnosis, aromatherapy, prayer therapy, music therapy and EFT. EFT (Emotional Freedom Techniques) envisages pressing and stimulating the meridian crossing points of the organs associated with these emotions in order to improve psychological conditions such as anger, sadness and anxiety. EFT can resolve emotional problems, reduce anxiety levels, make the person feel calmer and think more positively, supporting maternal and fetal health.

A review of the literature shows that mothers have the most problems with pain, breastfeeding and mobilization after cesarean section and need help with these problems; 78% of women who gave birth by cesarean section experience moderate to severe pain, which negatively affects maternal comfort, and mothers who undergo cesarean section experience unbearable pain of different intensities. In the world, anxiety and depression in the postpartum period have increased in the last decade, as Hada et al. (2019) reported in their study. Postpartum depression rates have been reported to be approximately 13% worldwide. Postpartum anxiety and depression are more common in the early postpartum period and in women who gave birth by cesarean section.

EFT has been reported to be effective in many other areas, including the treatment of disorders such as generalized or specific anxiety, morbid fears, depression, posttraumatic stress disorder, chronic pain and addiction. However, so far, no study has examined the effect of EFT on postpartum feelings of safety, anxiety and postoperative pain together. In the light of this information, unlike the studies in the literature, this study will be conducted to examine the effect of EFT applied before cesarean section on postpartum feelings of safety, anxiety and postoperative pain. In this context, anxiety levels, pain intensity and postpartum feelings of safety will be evaluated in the post-cesarean period. Therefore, it is thought that the results obtained from the study will guide future studies and make a significant contribution to the literature.

Eligibility criteria: Inclusion Criteria:

* primary school graduate
* primiparous
* planned cesarean section
* Postoperative pain of 4 or more according to VAS.

Exclusion Criteria:

* Heart disease
* high blood pressure
* chronic diseases such as diabetes
* history of miscarriage
* placenta previa
* mental illness in the last year
* use of psychoactive drugs
* drug addiction
* cigarette smoking
* preeclampsia
* bleeding
* intrauterine death
* premature birth

Primary outcomes:
measure: EFT for women who had a planned caesarean section
timeFrame: 0-24 hour
measure: 2. EFT for women with a planned cesarean section
timeFrame: 0-24 hour
Secondary outcomes:
measure: 3.EFT for women with a planned cesarean section
timeFrame: 0-24 hour
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Hafize Dağ Tüzmen
Study officials:
References: