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Music Therapy for Women, Delivered Via Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111575
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eylem Toker, Kahramanmaras Sutcu Imam University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Postpartum Period Behavioral: Music Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: The Effect of Turkish Classical Music on Postpartum Pain and Anxiety in Women Who Delivered Via Cesarean Section
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: music therapy group 1
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.
Behavioral: Music Therapy
Music Therapy
Other Name: musicotherapy

Experimental: music therapy group 2
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.
Behavioral: Music Therapy
Music Therapy
Other Name: musicotherapy

No Intervention: control group
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.



Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111575


Locations
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Turkey
Eylem TOKER
Kahramanmaraş, Dulkadiroglu, Turkey, 46100
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Additional Information:
Publications of Results:
Other Publications:
Şahin, NH. Cesarean Section: Prevalence and Consequences. Journal of Maltepe University Nursing Science and Art 2009;2:93-98.
Altuntaş H., Dansuk R., Köse O. Evaluation of Cesarean Ratios in Terms of Several Variables. KÜ Tıp Fak Derg 2013;15: 1-7.
Yüksel N. Anxiety disorders. In: Yüksel N, ed. Mental Disorders. 3rd ed. Ankara:MN Medikal & Nobel; 2006:143-182.
Gürkan A, Bilge A. Alternative therapies and psychiatric nursing. Ege Univ JNurs High School. 2006;22:225-232.
Schmidt LA, Trainor LJ. Frontal brain electrical activity (EEG) distinguishes valence and intensity of musical emotions. Cogn Emot. 2001;15:487-500.
Procelli DE. The effects of music therapy and relaxation prior to breastfeeding on the anxiety of new mothers and the behavior state of their ınfants during feeding. F.S.U. College of Music, MA Thesis, Florida, United States; 2005.
Mamuk R, Davas Nİ. Non-pharmacological relaxation and sensual stimulation methods used in the control of delivery pain. Med Bull Sisli Etfal Hosp. 2010;44:137-144.
Ersanlı C. The effect of music listened by primigravidae treated with induction of labor through training during labor on delivery process. M.U. Health Sciences Institute, MA Thesis, Istanbul, Turkey; 2007.
Çatalgöl Ş. The effect of ney sound listened by primigravidae treated with induction of labor through training during labor on delivery process. E U. Health Sciences Institute, MA Thesis, İzmir; 2013

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Responsible Party: Eylem Toker, Assistant Professor Doctor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT04111575    
Other Study ID Numbers: 19.04.2017/No:7-35
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eylem Toker, Kahramanmaras Sutcu Imam University:
cesarean section
Music therapy
Anxiety
Pain