PregnancyNCT06496932
Music for Anxiety Management in Cesarean Delivery
A study testing Listen to music in people with Pregnancy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Listen to music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Feb 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-35 years,
- Undergoing cesarean section under spinal anesthesia,
- Experiencing spontaneous and singleton pregnancy,
- With a gestational age greater than 37 weeks,
- Pregnant individuals who have had at least 4 routine check-ups during pregnancy conducted by a member of the research team,
- Scheduled for cesarean section (regardless of the number of previous cesarean sections).
Who cannot join
- Having high-risk pregnancies such as preeclampsia, early membrane rupture, and placental abruption, • Being scheduled for emergency cesarean section for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Anxiety and Vital Signs With Music in Cesarean Delivery: A Randomized Controlled Trial
A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs.
Read the detailed description
It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of anxiety and vita lsymptoms.
- Conditions
- Pregnancy
- Being tested
- Listen to music
- Keywords
- cesarean section, music, randomize trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listen to musicOther
Women in the intervention groups will listen to nature and bird sounds through over-the-ear headphones after spinal anesthesia for cesarean section until the suturing is completed.
| Study group | Role | What they receive |
|---|---|---|
| Listen to music group | Experimental | The study group will be played music during the cesarean section. Receives: Other: Listen to music |
| Standart cesarean procedure | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiete level
State-Trait Anxiety Inventory: It can be applied to individuals over the age of 14. It consists of 20 items that determine how an individual feels at a certain moment and under certain conditions. The highest score that can be obtained from the scale is 80 and the lowest score is 20. The higher the calculated total anxiety score, the higher the anxiety level of the person filling out the inventory.
Measured: 37th gestational weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Sep 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Dündar, Aydin Adnan Menderes University
- Investigators
- Tuğba Dündar, Study chair, AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496932
- Sponsor's protocol ID
- Interventional trial
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Anxiety and Vital Signs With Music in Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06496932
- Acronym / sponsor ID
- Interventional trial
- Conditions
- Pregnancy
- Keywords
- cesarean section, music, randomize trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 11 Jul 2024 (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.
A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs.
Detailed description
It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of anxiety and vita lsymptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Listen to music group | Experimental | Other: Listen to musicThe study group will be played music during the cesarean section. |
| Standart cesarean procedure | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18-35 years,
- Undergoing cesarean section under spinal anesthesia,
- Experiencing spontaneous and singleton pregnancy,
- With a gestational age greater than 37 weeks,
- Pregnant individuals who have had at least 4 routine check-ups during pregnancy conducted by a member of the research team,
Key exclusion criteria (1 listed)
- Having high-risk pregnancies such as preeclampsia, early membrane rupture, and placental abruption, • Being scheduled for emergency cesarean section for any reason
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 |
|---|---|---|
| Listen to musicWomen in the intervention groups will listen to nature and bird sounds through over-the-ear headphones after spinal anesthesia for cesarean section until the suturing is completed. | Other | Listen to music group |
Primary outcome
anxiete level
Time frame: 37th gestational weeks]
State-Trait Anxiety Inventory: It can be applied to individuals over the age of 14. It consists of 20 items that determine how an individual feels at a certain moment and under certain conditions. The highest score that can be obtained from the scale is 80 and the lowest score is 20. The higher the calculated total anxiety score, the higher the anxiety level of the person filling out the inventory.
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 12 Jul 2024.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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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.
Tuğba Dündar study chair
AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listen to music in people with Pregnancy, 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 6 inclusion and 1 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 12 Jul 2024. 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?
anxiete level (time frame: 37th gestational weeks]). 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 12 Jul 2024.