Anxiety, Breastfeeding, Cesarean Section, Lactation
Conditions
Keywords
oksitosin, prolaktin, pozitif olumlamalar, breastfeeding, Music Therapy, Anxiety, Cesarean Section
Brief summary
In pregnant women, non-pharmacological methods such as music, massage, yoga, meditation, relaxation breathing exercises, and acupuncture have been tried to reduce anxiety during childbirth, and there are studies on these in the literature. However, researchers have not come across a study in the literature that evaluates the effect of positive affirmations on perioperative maternal anxiety and breastfeeding together. Researchers aim is to evaluate the relationship between anxiety, sedation, and breastfeeding levels in pregnant women who underwent positive affirmations and music therapy during cesarean section.
Detailed description
The study was designed as a prospective randomized study. Patients were randomly assigned to groups using computer-assisted methods. Clinical study registration was completed after obtaining approval number 2023/234 from the Non-Interventional Ethics Committee of Adnan Menderes University Hospital. Pregnant women undergoing cesarean section were divided into three groups: Group 1 received pre-operative affirmations accompanied by music, Group 2 received only music, and the control group (Group 3) received neither music nor affirmations. After the operation, all three groups were assessed using the State-Trait Anxiety Scale (STAI), Hospital Anxiety and Depression Scale (HADS), and Visual Analog Scale-Anxiety (VAS-A) for anxiety level tests. Patient status index, hormones (prolactin, oxytocin), time to first milk production, and breastfeeding intensity were compared. Breastfeeding intensity was calculated as \[weekly number of breastfeeding sessions / (weekly number of breastfeeding sessions + formula feeding sessions)\].
Interventions
BEHAVIORALpozitif affirmation with music
Participants listened to classical music accompanied by positive affirmations for approximately 30 minutes during the perioperative period of cesarean section in order to reduce maternal anxiety and improve breastfeeding outcomes.
BEHAVIORALMusic listening
Participants listened to classical music for approximately 30 minutes during the perioperative period of cesarean section.
Sponsors
Aydin Adnan Menderes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study is a prospective randomized parallel-group trial including three groups: music with positive affirmations, music only, and a control group receiving no intervention. Participants are randomly assigned to one of the three groups and outcomes are compared between groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women aged 18-45 years * ASA physical status I-II * Scheduled for elective cesarean section under regional anesthesia * Ability to understand and complete the anxiety questionnaires * Provided written informed consent
Exclusion criteria
* Refusal to participate in the study * Hearing impairment preventing music listening * Psychiatric disorders affecting anxiety assessment * Emergency cesarean section * Known endocrine disorders affecting prolactin or oxytocin levels * İnability to communicate or complete the questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory score | Baseline (preoperative ward assessment), after 30-minute intervention before surgery, and postoperative recovery unit (within 1 hour after cesarean section) | Maternal anxiety level assessed using the State-Trait Anxiety Inventory (STAI). Scores range from 20 to 80, with higher scores indicating greater anxiety. |
| Hospital Anxiety and Depression Scale - Anxiety subscale | Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery). | Maternal anxiety level measured using the Hospital Anxiety and Depression Scale - Anxiety subscale. Scores range from 0 to 21, with higher scores indicating greater anxiety. |
| Visual Analog Scale for Anxiety | Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery). | Maternal anxiety assessed using a Visual Analog Scale ranging from 0 to 10, where higher scores indicate greater anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sedation level | Baseline (preoperative ward assessment), after the 30-minute intervention before surgery, and in the postoperative recovery unit within 1 hour after cesarean section. | Sedation level assessed using the Patient State Index (PSI) recorded during the perioperative period. |
| Oxytocin level | Postoperative day 1 and postoperative day 2 | Maternal serum oxytocin levels measured after breastfeeding in the postpartum period. |
| Prolactin level | Postoperative day 1 and postoperative day 2 | Maternal serum prolactin levels measured in the postpartum period after breastfeeding. |
| Time to first lactation | Within the first 48 hours after delivery | Time from delivery to the first breast milk expression recorded in the postpartum period. |
| Breastfeeding intensity | Postoperative day 1 and postoperative day 2 | Breastfeeding frequency recorded in the postpartum period. |
Countries
Turkey (Türkiye)
Outcome results
None listed