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Cesarean SectionNCT05570201

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

A study of Cesarean Section, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 19 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Section
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2019to 31 Mar 2020
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 19 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Sukran Ertekin Pınar

    Sivas, 58140

Other trials in Turkey (Türkiye)

About this study

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

Read the detailed 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.

Being tested
Control group
Keywords
Anxiety and depression, fear of surgery, listening to music, planned training, cesarean section
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupOther

    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

Study groups in NCT05570201
Study groupRoleWhat they receive
Experimental GroupExperimentalBy 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.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 15 months

Secondary outcomes (1)

  1. 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.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start1 Dec 2019
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05570201
Sponsor's protocol ID
TRSİVAS 01
Status last verified
Oct 2022
First submitted
4 Oct 2022
Last updated
6 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • 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.

    PubMed 26382109

  • 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.

    PubMed 16714913

  • 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.

    PubMed 16149980

  • 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.

    PubMed 33209932

  • 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.

    PubMed 30390639

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

    PubMed 5382598

  • 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.

    PubMed 15122417

  • 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.

    PubMed 20492051

  • 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.

    PubMed 27761627

  • 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.

    PubMed 29157759

  • 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.

    PubMed 30545420

  • 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.

    PubMed 27375388

  • 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.

    PubMed 34182584

  • 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.

    PubMed 31091276

  • 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.

    PubMed 24960025

Questions about this trial

What is this clinical trial studying?

A study of Cesarean Section, run by Cumhuriyet 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 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 6 Oct 2022. 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?

Likert type scale (time frame: 15 months). 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 NCT05570201, which also lists 17 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 6 Oct 2022.

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