Chest PainNCT06670027
The Effects of Use of Auditory Stimulation Methods on Cardiac Patients' Clinical Outcomes
A study testing Family voice and Nature sound in people with Chest Pain and Anxiety, run by Damanhour University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Anxiety, Sleep
- What is being tested?
- Family voice and Nature sound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult (aged≥18 years).
- diagnosed with cardiac disease.
- patient with hemodynamic stability
- consciousness and ability to communicate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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)
- Conditions
- Chest Pain, Anxiety, Sleep
- Being tested
- Family voice, Nature sound
- Medical subject headings
- Chest Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family voiceOther
Group A receives the family voice
Nature soundOther
Group B receives the nature sound.
| Study group | Role | What they receive |
|---|---|---|
| Family voice | Experimental | The patient receives family voice from significant member Receives: Other: Family voice |
| Nature sound | Active comparator | Patient receives nature sounds such as waves sound, river streams, waterfalls, and walking in the forest Receives: Other: Nature sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three days after intervention
severity of chest pain
Visual analogue scale consisted of score from 0 to 10 zero mean no pain and 10 mean high pain
Measured: three days after intervention
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
Measured: three days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Group A will receive a family voice message and Group B will be received nature sound
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670027
- Sponsor's protocol ID
- Auditory stimulation
- Status last verified
- Jun 2024
- First submitted
- 31 Oct 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Auditory Stimulation Methods on Cardiac Patients' Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06670027
- Acronym / sponsor ID
- Auditory stimulation
- Conditions
- Chest Pain, Anxiety, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A will receive a family voice message and Group B will be received nature sound
| Arm | Type | Receives |
|---|---|---|
| Family voice | Experimental | Other: Family voiceThe patient receives family voice from significant member |
| Nature sound | Active comparator | Other: Nature soundPatient receives nature sounds such as waves sound, river streams, waterfalls, and walking in the forest |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adult (aged≥18 years).
- diagnosed with cardiac disease.
- patient with hemodynamic stability
- consciousness and ability to communicate.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family voiceGroup A receives the family voice | Other | Family voice |
| Nature soundGroup B receives the nature sound. | Other | Nature sound |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family voice and Nature sound in people with Chest Pain and Anxiety, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: three days after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.