NCT05570201

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 4, 2022

Last Update Submit

October 4, 2022

Conditions

Keywords

Anxiety and depressionfear of surgerylistening to musicplanned trainingcesarean section

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Anxiety and Depression sub-scale

    15 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

By visiting the women who met the research criteria, the purpose of the study was explained and their written informed consent was obtained. This study was conducted in two sessions using pre- and post-tests. The Personal Information Form, the SFQ, and the HADS were filled out using the face-to-face interview method by the researcher for the women included in the music and training on the day of their hospitalization, which lasted for 30-45 minutes.

Other: Control group

Interventions

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

Experimental Group

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sukran Ertekin Pınar

Sivas, 58140, Turkey (Türkiye)

Location

Related 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.

    PMID: 26382109BACKGROUND
  • 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. doi: 10.1097/00005237-200604000-00007.

    PMID: 16714913BACKGROUND
  • 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. doi: 10.1111/j.1365-2648.2005.03563.x.

    PMID: 16149980BACKGROUND
  • 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.

    PMID: 33209932BACKGROUND
  • 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.

    PMID: 30390639BACKGROUND
  • Shabel'nik DIa, Grinchishin SA. [Polychlorpinene poisoning]. Sud Med Ekspert. 1969 Jul-Sep;12(3):47-8. No abstract available. Russian.

    PMID: 5382598BACKGROUND
  • 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. doi: 10.1590/s0041-87812004000200001. Epub 2004 Apr 26.

    PMID: 15122417BACKGROUND
  • 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.

    PMID: 20492051BACKGROUND
  • 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.

    PMID: 27761627BACKGROUND
  • 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.

    PMID: 29157759BACKGROUND
  • Ribeiro MKA, Alcantara-Silva TRM, Oliveira JCM, Paula TC, Dutra JBR, Pedrino GR, Simoes 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.

    PMID: 30545420BACKGROUND
  • 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.

    PMID: 27375388BACKGROUND
  • 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.

    PMID: 34182584BACKGROUND
  • 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.

    PMID: 31091276BACKGROUND
  • 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.

    PMID: 24960025BACKGROUND
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND
  • Bagdigen M, Karaman Ozlu 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.

    PMID: 30236578BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • sukran Ertekin Pınar

    Cumhuriyet Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.Dr.

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

December 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations