The Effects of Use of Auditory Stimulation Methods on Cardiac Patients' Clinical Outcomes

January 18, 2025 updated by: Damanhour University

The Effects of Using Auditory Stimulation Methods on Cardiac Patients' Clinical Outcomes

This study will be used to compare the effects of two auditory stimulation methods on improving vital signs parameters, reducing the severity of chest pain, and improving the sleep quality of cardiac patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to To evaluate the relative efficacy of two auditory stimulation techniques in enhancing cardiac patients' vital sign assessments.

  • This study aims to examine two auditory stimulations for their ability to alleviate chest pain in patients with heart conditions.
  • The goal of this study is to evaluate two audio stimulations for their potential to help heart patients have a better night's rest.

This research made use of two different therapies including audio stimulation. Group A used familiar auditory stimulus, which was a spoken message, and group B used sounds of nature.

Patients with preexisting cardiac conditions who were admitted to a predetermined critical care unit and who subsequently intended to have percutaneous coronary artery intervention (PCI)

Study Type

Interventional

Enrollment (Actual)

80

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

  • Egypt
      • Damanhūr, Egypt
        • Faculty of nursing Damanhour university

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • adult (aged≥18 years).
  • diagnosed with cardiac disease.
  • patient with hemodynamic stability
  • consciousness and ability to communicate.

Exclusion Criteria:

  • patients unable to comply with study interventions
  • patients with cognitive impairment
  • patients with severe unstable cardiac condition
  • having a history of hearing loss or the use of a hearing aid.

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family voice
The patient receives family voice from significant member
Other: Family voice
Group A receives the family voice
Active Comparator: Nature sound
Patient receives nature sounds such as waves sound, river streams, waterfalls, and walking in the forest
Other: Nature sound
Group B receives the nature sound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: three days after intervention
sleep quality used Richards-Campbell Sleep Questionnaire (RCSQ). it consisted of five items score from zero mean poor pattern and 100 mean good
three days after intervention
severity of chest pain
Time Frame: three days after intervention
Visual analogue scale consisted of score from 0 to 10 zero mean no pain and 10 mean high pain
three days after intervention
level of anxiety and depression
Time Frame: three days after intervention
The hospital Anxiety and Depression (HAD) questionnaire consisted of 14 questions 7 for anxiety and 7 for depression score score 0-7 mean normal; score 8-10 mean mild; score 11-15, mean moderate; and score 16-21, mean severely
three days after intervention

Collaborators and Investigators

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

Sponsor

Damanhour University

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)

July 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 18, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Auditory stimulation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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