Effect of Singing in Abdominal Surgery Patients | NCT06486701

Studies
Effect of Singing in Abdominal Surgery Patients

NCT06486701

Sponsor

Istanbul Aydın University

Status

Completed

Last Update Posted

Jul 3, 2024Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Abdominal Pain
Anxiety

Interventions

have a sing

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

Jun 2024

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

Jan 1, 2024Actual

Primary Completion Date

Feb 1, 2024Actual

Completion Date

Feb 9, 2024Actual

First Submitted Date

May 1, 2024

First Submission Date that Met QC Criteria

Jun 27, 2024

First Posted Date

Jul 3, 2024Actual

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

Jun 27, 2024

Last Update Posted Date

Jul 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SEMRA BÜLBÜLOĞLU, Clinical Assoc. Professor, Istanbul Aydın UniversityPrincipal Investigator

Lead Sponsor

Istanbul Aydın UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. Vital signs, pain and anxiety levels are measured before and after singing.

Detailed Description

This study is of a randomized controlled type. Patients who have undergone abdominal surgery are divided into experimental and control groups in the early postoperative period. No intervention is made to the control group by the researchers. Vital signs, pain and anxiety levels are measured half an hour apart as pre-test and post-test.

Patients in the experimental group are given a prompt in the postoperative period and asked to sing the song they remember. Pre-test before singing and post-test after singing, vital signs, pain and anxiety levels are measured. It is expected that singing will calm patients, stabilize their vital signs, and reduce anxiety and pain.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Singing	Behavioral: have a sing
No intervention	No Intervention	Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
have a sing	Behavioral	Singing	Experimental	Singing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and anxiety	It will be measure to sing a song after Abdominal Surgery	total of six month

Secondary Outcomes

Measure	Description	Time Frame
Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and Anxiety	No intervention, the control group abdominal surgery patients	total of six month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Abdominal surgery patiens
18 and more than age

Exclusion Criteria:

No abdominal surgery patients
under 18 age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 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
Medicana Kadikoy Hospital		Istanbul		34697	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

Condition Browse Module

MeSH Terms

ID	Term
D015746	Abdominal Pain
D001008	Anxiety Disorders
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063346	Singing

Ancestor Terms

ID	Term
D010699	Phonation
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided