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CompletedNCT06670027Updated Jan 22, 2025

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

An interventional study of Family voice and Nature sound in Chest Pain, Anxiety and Sleep, sponsored by Damanhour University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Damanhour University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2024, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the 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)

02

Conditions studied

  • Chest Pain
  • Anxiety
  • Sleep

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03

In context

Chest Pain

381 studies on the registry are indexed under Chest Pain; 66 are open to participants now.

This study's enrollment of 80 is below the median of 143 across 201 interventional studies indexed under Chest Pain.

Browse Chest Pain studies →

Lead sponsor

Damanhour University is the lead sponsor of 76 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Family voice

    The patient receives family voice from significant member

    Other: 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

Interventions

  • OtherFamily voice

    Group A receives the family voice

  • OtherNature sound

    Group B receives the nature sound.

06

What researchers measure

Primary outcomes

  1. sleep quality

    sleep quality used Richards-Campbell Sleep Questionnaire (RCSQ). it consisted of five items score from zero mean poor pattern and 100 mean good

    Time frame: three days after intervention

  2. severity of chest pain

    Visual analogue scale consisted of score from 0 to 10 zero mean no pain and 10 mean high pain

    Time frame: three days after intervention

  3. level of anxiety and depression

    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

    Time frame: three days after intervention

07

Study locations

1 site
  • Faculty of nursing Damanhour university
    Damanhūr, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06670027
Lead sponsor
Damanhour University
Responsible party
Sponsor
First posted
Nov 1, 2024
Start date
Jul 1, 2024
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024
Last update
Jan 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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