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

October 4, 2022 updated by: Sukran Ertekin Pinar, Cumhuriyet University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sivas, Turkey, 58140
        • Sukran Ertekin Pınar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental Group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert type scale
Time Frame: 15 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression sub-scale
Time Frame: 15 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Investigators

  • Principal Investigator: sukran Ertekin Pınar, Cumhuriyet Universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2019

Primary Completion (ACTUAL)

March 31, 2020

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (ACTUAL)

October 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRSİVAS 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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