The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing

NCT ID: NCT04894487

Last Updated: 2021-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies. The research was carried out with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38, Control Group: 38). Data were collected by using the "Baby Monitoring Form" and "FLACC Pain Scale".

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Procedural (During Sternum Dressing on Infants) Physiological Parameters During Sternum Dressing in Babies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled two groups ( control group and experiment group)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

The babies have got sternum incision after the pediatric cardiac surgery. Experiment is about the dressing of the sternum incision. There is no extra intervention during sternum dressing at control group like routine of pediatric cardiovascular surgery intensive care clinic. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing.

Group Type NO_INTERVENTION

No interventions assigned to this group

THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP

Baby mobile and Brahms Lullaby started before the 10 minutes of sternum dressing process and controlled permanence of the baby mobile and Brahms Lullaby during sternum dressing. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing.

Group Type EXPERIMENTAL

THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY

Intervention Type BEHAVIORAL

Using of baby mobile and listening Brahms Lullaby during sternum dressing process

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY

Using of baby mobile and listening Brahms Lullaby during sternum dressing process

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being 1-12 months
* Being volunteer for research
* Operated for Congenital Heart Disease
* Got Sternum incision
* No other chronic illness
* No similar surgical experiment before
* No visual impairment
* No hearing impairment
* No mental or neurological impairment
* Hospitalization experience

Exclusion Criteria

\-
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Okan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kamil KARAKAYA

Principal Investigator, RN, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Pediatric Cardiovascular Surgery Intensice Care Unit

Küçükçekmece, Istanbul, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15761188

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non-Pharmacological Methods in Heel Lance
NCT07348731 NOT_YET_RECRUITING NA