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

Sponsor

Cumhuriyet University (Other)

Overall Status

Completed

CT.gov ID

NCT05570201

Collaborator

(none)

120

Enrollment

Location

Arm

Actual Duration (Months)

30.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Other: Control group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Likert type scale [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".

Secondary Outcome Measures

Anxiety and Depression sub-scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sukran Ertekin Pınar	Sivas		Turkey	58140

Sponsors and Collaborators

Cumhuriyet University

Investigators

Principal Investigator: sukran Ertekin Pınar, Cumhuriyet Universty

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Sukran Ertekin Pinar, Assoc. Prof.Dr., Cumhuriyet University

ClinicalTrials.gov Identifier:

NCT05570201

Other Study ID Numbers:

TRSİVAS 01

First Posted:

Oct 6, 2022

Last Update Posted:

Oct 6, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sukran Ertekin Pinar, Assoc. Prof.Dr., Cumhuriyet University

Anxiety and depression

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Oct 6, 2022