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

NCT06670027 | Completed

• 1 other identifier: Auditory stimulation
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chest Pain; Anxiety; Sleep

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  three days after intervention

Study Arms (2)

Family voice

EXPERIMENTAL

The patient receives family voice from significant member

Other: Family voice

Nature sound

ACTIVE COMPARATOR

Patient receives nature sounds such as waves sound, river streams, waterfalls, and walking in the forest

Other: Nature sound

Interventions

Family voice OTHER

Group A receives the family voice

Family voice

Nature sound OTHER

Group B receives the nature sound.

Nature sound

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Faculty of nursing Damanhour university

Damanhūr, Egypt

Location

MeSH Terms

Conditions

Chest Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A will receive a family voice message and Group B will be received nature sound

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-06

Locations

EG (1)