Cesarean SectionBreastfeedingNCT07481643
Evaluation Of The Effect Of Affirmations During Cesarean Section Accompanying By Musıc On Breastfeeding
A study testing pozitif affirmation with music and Music listening in people with Cesarean Section and Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Anxiety, Breastfeeding
- What is being tested?
- pozitif affirmation with music and Music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Aug 2024to 30 Jun 2025
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University Hospital
Aydin, Aydın, 09010
About this study
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.
Read the 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)].
- Conditions
- Cesarean Section, Anxiety, Breastfeeding, Lactation
- Being tested
- pozitif affirmation with music, Music listening
- Keywords
- oksitosin, prolaktin, pozitif olumlamalar, breastfeeding, Music Therapy, Anxiety, Cesarean Section
- Medical subject headings
- Anxiety Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pozitif affirmation with musicBehavioural
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.
Music listeningBehavioural
Participants listened to classical music for approximately 30 minutes during the perioperative period of cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Arm Title: Music Only | Experimental | Patients listen to classical music for 30 minutes before and during the cesarean section. Receives: Behavioral: Music listening |
| Arm Title: Music with Positive Affirmations | Experimental | Patients listen to classical music accompanied by positive affirmations during the perioperative period. Receives: Behavioral: pozitif affirmation with music |
| Control | No intervention | Participants in the control group received standard perioperative care without music or positive affirmations during the cesarean section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery).
Secondary outcomes (5)
sedation level
Sedation level assessed using the Patient State Index (PSI) recorded during the perioperative period.
Measured: 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
Maternal serum oxytocin levels measured after breastfeeding in the postpartum period.
Measured: Postoperative day 1 and postoperative day 2
Prolactin level
Maternal serum prolactin levels measured in the postpartum period after breastfeeding.
Measured: 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.
Measured: Within the first 48 hours after delivery
Breastfeeding intensity
Breastfeeding frequency recorded in the postpartum period.
Measured: Postoperative day 1 and postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start22 Aug 2024
- Primary completion5 Feb 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile kıyıkcı Taşkoparan, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481643
- Sponsor's protocol ID
- 2023234
- Other IDs
- TPF-24007
- Acronym
- Breastfeeding
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of Affirmations During Cesarean Section Accompanying By Musıc On Breastfeeding
- ClinicalTrials.gov ID
- NCT07481643
- Acronym / sponsor ID
- Breastfeeding / 2023234
- Conditions
- Cesarean Section, Anxiety, Breastfeeding, Lactation
- Keywords
- oksitosin, prolaktin, pozitif olumlamalar, breastfeeding, Music Therapy, Anxiety, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Mar 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.
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)].
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm Title: Music Only | Experimental | Behavioral: Music listeningPatients listen to classical music for 30 minutes before and during the cesarean section. |
| Arm Title: Music with Positive Affirmations | Experimental | Behavioral: pozitif affirmation with musicPatients listen to classical music accompanied by positive affirmations during the perioperative period. |
| Control | No intervention | –Participants in the control group received standard perioperative care without music or positive affirmations during the cesarean section. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| pozitif affirmation with musicParticipants 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. | Behavioural | Arm Title: Music with Positive Affirmations |
| Music listeningParticipants listened to classical music for approximately 30 minutes during the perioperative period of cesarean section. | Behavioural | Arm Title: Music Only |
Primary outcome
State-Trait Anxiety Inventory score
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
sedation level
Time frame: 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
Time frame: Postoperative day 1 and postoperative day 2
Prolactin level
Time frame: Postoperative day 1 and postoperative day 2
Time to first lactation
Time frame: Within the first 48 hours after delivery
Breastfeeding intensity
Time frame: Postoperative day 1 and postoperative day 2
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 19 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pozitif affirmation with music and Music listening in people with Cesarean Section and Anxiety, run by Aydin Adnan Menderes University at 1 site 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 5 inclusion and 6 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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-Trait Anxiety Inventory score (time frame: Baseline (preoperative ward assessment), after 30-minute intervention before surgery, and postoperative recovery unit (within 1 hour after cesarean section)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.