Effect of Preoperative Music on Anxiety | NCT03816501

Studies
Effect of Preoperative Music on Anxiety

NCT03816501

Sponsor

Ankara Diskapi Training and Research Hospital

Status

Completed

Last Update Posted

Sep 25, 2019Actual

Enrollment

117Actual

Phase

Not Applicable

Conditions

Music on Postoperative Anxiety

Interventions

music
no music

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

May 15, 2019Actual

First Submitted Date

Jan 23, 2019

First Submission Date that Met QC Criteria

Jan 23, 2019

First Posted Date

Jan 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2019

Last Update Posted Date

Sep 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fatma Kavak Akelma, anesthesiology and reanimation specialist doctor, Ankara Diskapi Training and Research HospitalPrincipal Investigator

Lead Sponsor

Ankara Diskapi Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to postoperative anxiety.

Detailed Description

Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) I and II.

117 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into two groups as preoperative music played and not played. The list of patients listening to the music will be played through the headphones which are the preference of the patients. The postoperative STAI questionnaire will be applied again. results will be evaluated statistically

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
music	Other	The preference of the patients will be listened to preoperatively through the headphones.	Other: music
no music	Other	preoperative music will not be listened	Other: no music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
music	Other	The preference of the patients will be listened to preoperatively through the headphones	music

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
STAI score	preoperative and postoperative STAI I and II score questions will be asked.	24 hours
11-point numerical rating scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

inguinal hernia surgery
speak Turkish language

Exclusion Criteria:

Patients with dementia and psychiatric disorders
anxiolytic and psychiatric drug users
patients without written consent
poor vision,
significant hearing loss,
active opioid use,
unwillingness to participate in the study
unwillingness to listening to music

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diskapi Teaching and Research Hospital		Ankara	Altindag		Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided