Cesarean SectionNCT04111575
Music Therapy for Women, Delivered Via Cesarean Section
A study testing Music Therapy in people with Cesarean Section and Postpartum Period, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Musical therapy is a type of therapy which is performed under a regular method by adjusting the physiological and psychological effects of musical tones and melodies in accordance with various situations. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Postpartum Period
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2018to 26 Oct 2018
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being at the age of 18 and above,
- being healthy,
- having given a live birth,
- having no hearing impairment,
- complication not having developed either in the mother or the baby
Who cannot join
- being at the age of 17 and below,
- being unhealthy,
- having given a stillbirth,
- having hearing impairment,
- complication having developed either in the mother or the baby
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eylem TOKER
Kahramanmaraş, Dulkadiroglu, 46100
About this study
Official title: The Effect of Turkish Classical Music on Postpartum Pain and Anxiety in Women Who Delivered Via Cesarean Section
Musical therapy is a type of therapy which is performed under a regular method by adjusting the physiological and psychological effects of musical tones and melodies in accordance with various situations. Therefore, the study was carried out as a randomized controlled trial in order to evaluate the effect of music therapy on the level of pain and anxiety in the postpartum period in women who delivered via cesarean section.
Read the detailed description
Objectives: The study was carried out in order to determine the effect of music therapy on the level of postpartum pain and anxiety in women who delivered via cesarean section.
Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants. In the analysis of the data, one-way ANOVA, paired t-test, Kruskal Wallis-H and Wilcoxon tests were used.
Main outcome measures: State anxiety level and pain level.
- Conditions
- Cesarean Section, Postpartum Period
- Being tested
- Music Therapy
- Keywords
- cesarean section, Music therapy, Anxiety, Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Also called musicotherapy
Music Therapy
| Study group | Role | What they receive |
|---|---|---|
| music therapy group 1 | Experimental | The mothers in the experimental group 1 received music therapy for 30 minutes a day.They listened music for two consecutive days, considering the first day after the C-section as the beginning day. Receives: Behavioral: Music Therapy |
| music therapy group 2 | Experimental | The mothers in the experimental group 1 received music therapy for 30 minutes twice a day. They listened music for two consecutive days, considering the first day after the C-section as the beginning day. Receives: Behavioral: Music Therapy |
| control group | No intervention | the control group were made to rest in bed for 30 minutes a day for two consecutive days, considering the first day after the C-section as the beginning day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
Anxiety level by State-Trait Anxiety Inventory
Measured: On the first and second days after C-section, change from first anxiety level at 30 minutes.The inventory has a Likert type scale of 20 items which aim to measure the state anxiety level.Higher scores indicate greater anxiety
Visual Analog Scale (VAS)
Pain Level by Visual Analog Scale
Measured: On the first and second days after C-section, change from first pain level at 30 minute.The patient marks the pain he/she feels on a scale of 10 cm (100 mm), pain point 1 means "no pain", pain point 10 means "worst pain possible."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start5 Feb 2018
- Primary completion2 Jul 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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
- Model description
- Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem Toker, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111575
- Sponsor's protocol ID
- 19.04.2017/No:7-35
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu J, Chaplin W, Amico J, Butler M, Ojie MJ, Hennedy D, Clemow L. Music for surgical abortion care study: a randomized controlled pilot study. Contraception. 2012 May;85(5):496-502. doi: 10.1016/j.contraception.2011.09.018. Epub 2011 Nov 12.
PubMed 22079604Bally K, Campbell D, Chesnick K, Tranmer JE. Effects of patient-controlled music therapy during coronary angiography on procedural pain and anxiety distress syndrome. Crit Care Nurse. 2003 Apr;23(2):50-8. No abstract available.
PubMed 12725195Ebneshahidi A, Mohseni M. The effect of patient-selected music on early postoperative pain, anxiety, and hemodynamic profile in cesarean section surgery. J Altern Complement Med. 2008 Sep;14(7):827-31. doi: 10.1089/acm.2007.0752.
PubMed 18803492Tournaire M, Theau-Yonneau A. Complementary and alternative approaches to pain relief during labor. Evid Based Complement Alternat Med. 2007 Dec;4(4):409-17. doi: 10.1093/ecam/nem012.
PubMed 18227907Toker E, Komurcu N. Effect of Turkish classical music on prenatal anxiety and satisfaction: A randomized controlled trial in pregnant women with pre-eclampsia. Complement Ther Med. 2017 Feb;30:1-9. doi: 10.1016/j.ctim.2016.11.005. Epub 2016 Nov 18.
PubMed 28137517Bekiroglu T, Ovayolu N, Ergun Y, Ekerbicer HC. Effect of Turkish classical music on blood pressure: a randomized controlled trial in hypertensive elderly patients. Complement Ther Med. 2013 Jun;21(3):147-54. doi: 10.1016/j.ctim.2013.03.005. Epub 2013 Apr 2.
PubMed 23642944Shin HS, Kim JH. Music Therapy on Anxiety, Stress and Maternal-fetal Attachment in Pregnant Women During Transvaginal Ultrasound. Asian Nurs Res (Korean Soc Nurs Sci). 2011 Mar;5(1):19-27. doi: 10.1016/S1976-1317(11)60010-8. Epub 2011 Apr 5.
PubMed 25029946Laopaiboon M, Lumbiganon P, Martis R, Vatanasapt P, Somjaivong B. Music during caesarean section under regional anaesthesia for improving maternal and infant outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006914. doi: 10.1002/14651858.CD006914.pub2.
PubMed 19370660Handan E, Sahiner NC, Bal MD, Dissiz M. Effects of Music during Multiple Cesarean Section Delivery. J Coll Physicians Surg Pak. 2018 Mar;28(3):247-249. doi: 10.29271/jcpsp.2018.03.247.
PubMed 29544589Hepp P, Hagenbeck C, Gilles J, Wolf OT, Goertz W, Janni W, Balan P, Fleisch M, Fehm T, Schaal NK. Effects of music intervention during caesarean delivery on anxiety and stress of the mother a controlled, randomised study. BMC Pregnancy Childbirth. 2018 Nov 3;18(1):435. doi: 10.1186/s12884-018-2069-6.
PubMed 30390639Moradipanah F, Mohammadi E, Mohammadil AZ. Effect of music on anxiety, stress, and depression levels in patients undergoing coronary angiography. East Mediterr Health J. 2009 May-Jun;15(3):639-47.
PubMed 19731780Ferrer AJ. The effect of live music on decreasing anxiety in patients undergoing chemotherapy treatment. J Music Ther. 2007 Fall;44(3):242-55. doi: 10.1093/jmt/44.3.242.
PubMed 17645387Tseng YF, Chen CH, Lee CS. Effects of listening to music on postpartum stress and anxiety levels. J Clin Nurs. 2010 Apr;19(7-8):1049-55. doi: 10.1111/j.1365-2702.2009.02998.x.
PubMed 20492049Kafali H, Derbent A, Keskin E, Simavli S, Gozdemir E. Effect of maternal anxiety and music on fetal movements and fetal heart rate patterns. J Matern Fetal Neonatal Med. 2011 Mar;24(3):461-4. doi: 10.3109/14767058.2010.501122. Epub 2010 Jul 7.
PubMed 20608798Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95.
PubMed 19713801
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Turkish Classical Music on Postpartum Pain and Anxiety in Women Who Delivered Via Cesarean Section
- ClinicalTrials.gov ID
- NCT04111575
- Acronym / sponsor ID
- 19.04.2017/No:7-35
- Conditions
- Cesarean Section, Postpartum Period
- Keywords
- cesarean section, Music therapy, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 1 Oct 2019 (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.
Musical therapy is a type of therapy which is performed under a regular method by adjusting the physiological and psychological effects of musical tones and melodies in accordance with various situations. Therefore, the study was carried out as a randomized controlled trial in order to evaluate the effect of music therapy on the level of pain and anxiety in the postpartum period in women who delivered via cesarean section.
Detailed description
Objectives: The study was carried out in order to determine the effect of music therapy on the level of postpartum pain and anxiety in women who delivered via cesarean section.
Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants. In the analysis of the data, one-way ANOVA, paired t-test, Kruskal Wallis-H and Wilcoxon tests were used.
Main outcome measures: State anxiety level and pain level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants.
| Arm | Type | Receives |
|---|---|---|
| music therapy group 1 | Experimental | Behavioral: Music TherapyThe mothers in the experimental group 1 received music therapy for 30 minutes a day.They listened music for two consecutive days, considering the first day after the C-section as the beginning day. |
| music therapy group 2 | Experimental | Behavioral: Music TherapyThe mothers in the experimental group 1 received music therapy for 30 minutes twice a day. They listened music for two consecutive days, considering the first day after the C-section as the beginning day. |
| control group | No intervention | –the control group were made to rest in bed for 30 minutes a day for two consecutive days, considering the first day after the C-section as the beginning day. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- being at the age of 18 and above,
- being healthy,
- having given a live birth,
- having no hearing impairment,
- complication not having developed either in the mother or the baby
Key exclusion criteria (5 listed)
- being at the age of 17 and below,
- being unhealthy,
- having given a stillbirth,
- having hearing impairment,
- complication having developed either in the mother or the baby
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 |
|---|---|---|
| Music TherapyAlso: musicotherapyMusic Therapy | Behavioural | music therapy group 1, music therapy group 2 |
Primary outcome
State-Trait Anxiety Inventory
Time frame: On the first and second days after C-section, change from first anxiety level at 30 minutes.The inventory has a Likert type scale of 20 items which aim to measure the state anxiety level.Higher scores indicate greater anxiety
Anxiety level by State-Trait Anxiety Inventory
Visual Analog Scale (VAS)
Time frame: On the first and second days after C-section, change from first pain level at 30 minute.The patient marks the pain he/she feels on a scale of 10 cm (100 mm), pain point 1 means "no pain", pain point 10 means "worst pain possible."
Pain Level by Visual Analog Scale
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 1 Oct 2019.
- Background: PubMed 22079604Wu J, Chaplin W, Amico J, Butler M, Ojie MJ, Hennedy D, Clemow L. Music for surgical abortion care study: a randomized controlled pilot study. Contraception. 2012 May;85(5):496-502. doi: 10.1016/j.contraception.2011.09.018. Epub 2011 Nov 12.
- Background: PubMed 12725195Bally K, Campbell D, Chesnick K, Tranmer JE. Effects of patient-controlled music therapy during coronary angiography on procedural pain and anxiety distress syndrome. Crit Care Nurse. 2003 Apr;23(2):50-8. No abstract available.
- Background: PubMed 18803492Ebneshahidi A, Mohseni M. The effect of patient-selected music on early postoperative pain, anxiety, and hemodynamic profile in cesarean section surgery. J Altern Complement Med. 2008 Sep;14(7):827-31. doi: 10.1089/acm.2007.0752.
- Background: PubMed 18227907Tournaire M, Theau-Yonneau A. Complementary and alternative approaches to pain relief during labor. Evid Based Complement Alternat Med. 2007 Dec;4(4):409-17. doi: 10.1093/ecam/nem012.
- Background: PubMed 28137517Toker E, Komurcu N. Effect of Turkish classical music on prenatal anxiety and satisfaction: A randomized controlled trial in pregnant women with pre-eclampsia. Complement Ther Med. 2017 Feb;30:1-9. doi: 10.1016/j.ctim.2016.11.005. Epub 2016 Nov 18.
- Background: PubMed 23642944Bekiroglu T, Ovayolu N, Ergun Y, Ekerbicer HC. Effect of Turkish classical music on blood pressure: a randomized controlled trial in hypertensive elderly patients. Complement Ther Med. 2013 Jun;21(3):147-54. doi: 10.1016/j.ctim.2013.03.005. Epub 2013 Apr 2.
- Background: PubMed 25029946Shin HS, Kim JH. Music Therapy on Anxiety, Stress and Maternal-fetal Attachment in Pregnant Women During Transvaginal Ultrasound. Asian Nurs Res (Korean Soc Nurs Sci). 2011 Mar;5(1):19-27. doi: 10.1016/S1976-1317(11)60010-8. Epub 2011 Apr 5.
- Background: PubMed 19370660Laopaiboon M, Lumbiganon P, Martis R, Vatanasapt P, Somjaivong B. Music during caesarean section under regional anaesthesia for improving maternal and infant outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006914. doi: 10.1002/14651858.CD006914.pub2.
- Background: PubMed 29544589Handan E, Sahiner NC, Bal MD, Dissiz M. Effects of Music during Multiple Cesarean Section Delivery. J Coll Physicians Surg Pak. 2018 Mar;28(3):247-249. doi: 10.29271/jcpsp.2018.03.247.
- Background: PubMed 30390639Hepp P, Hagenbeck C, Gilles J, Wolf OT, Goertz W, Janni W, Balan P, Fleisch M, Fehm T, Schaal NK. Effects of music intervention during caesarean delivery on anxiety and stress of the mother a controlled, randomised study. BMC Pregnancy Childbirth. 2018 Nov 3;18(1):435. doi: 10.1186/s12884-018-2069-6.
- Background: PubMed 19731780Moradipanah F, Mohammadi E, Mohammadil AZ. Effect of music on anxiety, stress, and depression levels in patients undergoing coronary angiography. East Mediterr Health J. 2009 May-Jun;15(3):639-47.
- Background: PubMed 17645387Ferrer AJ. The effect of live music on decreasing anxiety in patients undergoing chemotherapy treatment. J Music Ther. 2007 Fall;44(3):242-55. doi: 10.1093/jmt/44.3.242.
- The World Health Statistics 2014. Accessed from: 2018Link provided by the sponsor.
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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 Music Therapy in people with Cesarean Section and Postpartum Period, run by Kahramanmaras Sutcu Imam 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 5 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 1 Oct 2019. 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 (time frame: On the first and second days after C-section, change from first anxiety level at 30 minutes.The inventory has a Likert type scale of 20 items which aim to measure the state anxiety level.Higher scores indicate greater anxiety). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111575, which also lists 36 linked publications.
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 1 Oct 2019.