Effects of Planned Training and Music Listened to Before a Cesarean Section on Surgical Fear, Anxiety and Depression

Cesarean Section Clinical Trial

Official title:

Effects of Planned Training and Music Listened to Before a Cesarean Section on Surgical Fear, Anxiety and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570201
• Other study ID #: TRSIVAS 01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2022
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research was conducted to determine the effect of training and listening to music before a cesarean section on the surgical fear, anxiety and depression

Description:

The sample of the experimental study consisted of 120 pregnant women (music: 40, training: 40, control: 40). The data were collected using the Personal Information Form, Surgical Fear Questionnaire, and the Hospital Anxiety and Depression Scale. After the training and listening to music applications, statistically significant differences were found between the music, training, and the control groups in terms of the short-term, long-term sub-scale scores and the overall score of the Surgical Fear Questionnaire, and the anxiety sub-scale scores of the Hospital Anxiety and Depression Scale (p < .05). Listening to music before the cesarean section was effective in reducing women's short-term and general surgical fears, and the training was also effective in reducing their short-term, long-term, and general surgical fears and anxiety levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

Inclusion Criteria:

• Women who were hospitalized for planned cesarean section,
• Having the first pregnancy,
• Between the ages 19 and 35,
• Who had no diagnosis of a physical or mental disease,
• Who had no physical illness in her baby Exclusion Criteria: -

Related Conditions & MeSH terms

• Cesarean Section
• Depression

Intervention

Other:
• Control group
No intervention was applied to the women in the control group, only the questionnaires (pre-test, post-test) were filled out. Filling the questionnaires lasted 10-15 minutes on average in all groups

Locations

Country	Name	City	State
Turkey	Sukran Ertekin Pinar	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (17)

Baert IA, Lluch E, Mulder T, Nijs J, Noten S, Meeus M. Does pre-surgical central modulation of pain influence outcome after total knee replacement? A systematic review. Osteoarthritis Cartilage. 2016 Feb;24(2):213-23. doi: 10.1016/j.joca.2015.09.002. Epub 2015 Sep 14. Review. — View Citation

Bagdigen M, Karaman Özlü Z. Validation of the Turkish Version of the Surgical Fear Questionnaire. J Perianesth Nurs. 2018 Oct;33(5):708-714. doi: 10.1016/j.jopan.2017.05.007. Epub 2017 Sep 21. — View Citation

Bastani F, Hidarnia A, Montgomery KS, Aguilar-Vafaei ME, Kazemnejad A. Does relaxation education in anxious primigravid Iranian women influence adverse pregnancy outcomes?: a randomized controlled trial. J Perinat Neonatal Nurs. 2006 Apr-Jun;20(2):138-46. — View Citation

Cooke M, Chaboyer W, Schluter P, Hiratos M. The effect of music on preoperative anxiety in day surgery. J Adv Nurs. 2005 Oct;52(1):47-55. — View Citation

Eslami J, Hatami N, Amiri A, Akbarzadeh M. The potential beneficial effects of education and familiarity with cesarean section procedure and the operating room environment on promotion of anxiety and pain intensity: A randomized controlled clinical trial. J Educ Health Promot. 2020 Sep 28;9:240. doi: 10.4103/jehp.jehp_31_20. eCollection 2020. — View Citation

Hepp 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. — View Citation

Kiyohara LY, Kayano LK, Oliveira LM, Yamamoto MU, Inagaki MM, Ogawa NY, Gonzales PE, Mandelbaum R, Okubo ST, Watanuki T, Vieira JE. Surgery information reduces anxiety in the pre-operative period. Rev Hosp Clin Fac Med Sao Paulo. 2004 Apr;59(2):51-6. Epub 2004 Apr 26. — View Citation

Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x. — View Citation

Moutzouri M, Gleeson N, Billis E, Tsepis E, Panoutsopoulou I, Gliatis J. The effect of total knee arthroplasty on patients' balance and incidence of falls: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3439-3451. doi: 10.1007/s00167-016-4355-z. Epub 2016 Oct 19. Review. — View Citation

Ramesh C, Nayak BS, Pai VB, Patil NT, George A, George LS, Devi ES. Effect of Preoperative Education on Postoperative Outcomes Among Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis. J Perianesth Nurs. 2017 Dec;32(6):518-529.e2. doi: 10.1016/j.jopan.2016.11.011. Epub 2017 Apr 13. Review. Erratum in: J Perianesth Nurs. 2018 Oct;33(5):748. — View Citation

Ribeiro MKA, Alcântara-Silva TRM, Oliveira JCM, Paula TC, Dutra JBR, Pedrino GR, Simões K, Sousa RB, Rebelo ACS. Music therapy intervention in cardiac autonomic modulation, anxiety, and depression in mothers of preterms: randomized controlled trial. BMC Psychol. 2018 Dec 13;6(1):57. doi: 10.1186/s40359-018-0271-y. — View Citation

Ruhaiyem ME, Alshehri AA, Saade M, Shoabi TA, Zahoor H, Tawfeeq NA. Fear of going under general anesthesia: A cross-sectional study. Saudi J Anaesth. 2016 Jul-Sep;10(3):317-21. doi: 10.4103/1658-354X.179094. — View Citation

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Shimada BMO, Santos MDSOMD, Cabral MA, Silva VO, Vagetti GC. Interventions among Pregnant Women in the Field of Music Therapy: A Systematic Review. Rev Bras Ginecol Obstet. 2021 May;43(5):403-413. doi: 10.1055/s-0041-1731924. Epub 2021 Jun 28. — View Citation

Sun Y, Huang K, Hu Y, Yan S, Xu Y, Zhu P, Tao F. Pregnancy-specific anxiety and elective cesarean section in primiparas: A cohort study in China. PLoS One. 2019 May 15;14(5):e0216870. doi: 10.1371/journal.pone.0216870. eCollection 2019. — View Citation

Theunissen M, Peters ML, Schouten EG, Fiddelers AA, Willemsen MG, Pinto PR, Gramke HF, Marcus MA. Validation of the surgical fear questionnaire in adult patients waiting for elective surgery. PLoS One. 2014 Jun 24;9(6):e100225. doi: 10.1371/journal.pone.0100225. eCollection 2014. Erratum in: PLoS One. 2016;11(9):e0162737. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likert type scale	The scale is an 11-point Likert type scale, consisting of 8 items, scored between 0 and 10 points each. The scale consists of two sub-scales, consisting of 4 items each, measuring short-term fears and long-term fears related to the source of fear. The items in the scale are evaluated as "0:I am not afraid at all" to "10:I am very afraid".	15 months
Secondary	Anxiety and Depression sub-scale	It is used for diagnosing anxiety and depression in a short time and determining the risk group. It's a 4-point Likert-type scale consisting of 14 items in total. There are 7 items in the Anxiety and Depression sub-scale, and they are scored in the range of 0-3 points. The lowest and highest scores that can be taken in the sub-scales are 0 and 21, respectively.	15 months

External Links

•   Effect of Education and Musical Therapy Given During Labor on the Process of Birth in Induced Primipara Pregnant Women
•   Impact of Face-to-Face Educational Outreach Plus Printed Materials on Preoperative Anxiety level in Iranian Parturient Undergoing Elective Cesarean Section Delivery
•   Relationship Between Perceived Social Support and Anxiety Before and After Cesarean in the Pregnant Women