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| ID | Type | Description | Link |
|---|---|---|---|
| TPF-24007 | Other Grant/Funding Number | Aydin Adnan Menderes University BAP |
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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.
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)].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Title: Music Only | Experimental | Patients listen to classical music for 30 minutes before and during the cesarean section. |
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| Arm Title: Music with Positive Affirmations | Experimental | Patients listen to classical music accompanied by positive affirmations during the perioperative period. |
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| Control | No Intervention | Participants in the control group received standard perioperative care without music or positive affirmations during the cesarean section. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pozitif affirmation with music | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory score | Maternal anxiety level assessed using the State-Trait Anxiety Inventory (STAI). Scores range from 20 to 80, with higher scores indicating greater anxiety. | Baseline (preoperative ward assessment), after 30-minute intervention before surgery, and postoperative recovery unit (within 1 hour after cesarean section) |
| Hospital Anxiety and Depression Scale - Anxiety subscale | 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. | Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery). |
| Visual Analog Scale for Anxiety | Maternal anxiety assessed using a Visual Analog Scale ranging from 0 to 10, where higher scores indicate greater anxiety. | Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery). |
| Measure | Description | Time Frame |
|---|---|---|
| sedation level | Sedation level assessed using the Patient State Index (PSI) recorded during the perioperative period. | Baseline (preoperative ward assessment), after the 30-minute intervention before surgery, and in the postoperative recovery unit within 1 hour after cesarean section. |
| Oxytocin level |
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Inclusion Criteria:
Exclusion Criteria:
Only pregnant women scheduled for elective cesarean section are eligible to participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydin Adnan Menderes University Hospital | Aydin | Aydın | 09010 | Turkey (Türkiye) |
Deidentified individual participant data collected during the study, including demographic data, anxiety scores, sedation levels, and breastfeeding outcomes, will be available upon reasonable request from the corresponding investigator after publication of the study results.
Deidentified individual participant data will be available beginning 6 months after publication of the study results and will remain available for 5 years upon reasonable request to the corresponding investigator.
Qualified researchers may request access to deidentified individual participant data for scientific purposes. Access will be granted upon reasonable request to the corresponding investigator and after approval of a research proposal.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 29, 2026 | |
| Reset | May 26, 2026 | |
| Release | Jun 1, 2026 | |
| Reset | Jun 25, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2026 | May 26, 2026 | |||
| Jun 1, 2026 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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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.
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| Music listening | Behavioral | Participants listened to classical music for approximately 30 minutes during the perioperative period of cesarean section. |
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Maternal serum oxytocin levels measured after breastfeeding in the postpartum period. |
| Postoperative day 1 and postoperative day 2 |
| Prolactin level | Maternal serum prolactin levels measured in the postpartum period after breastfeeding. | Postoperative day 1 and postoperative day 2 |
| Time to first lactation | Time from delivery to the first breast milk expression recorded in the postpartum period. | Within the first 48 hours after delivery |
| Breastfeeding intensity | Breastfeeding frequency recorded in the postpartum period. | Postoperative day 1 and postoperative day 2 |
| Jun 25, 2026 |