The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures

NCT03642015 | Completed

• 1 other identifier: TSGH-C97-151
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigated the effect of listening to self-selected music on anxiety and physiological responses in patients prior to gastroscopy. A randomized controlled trial was conducted, in which patients scheduled for gastroscopy in a medical center located in Taipei, Taiwan, were enrolled. The experimental group listened to self-selected music with earphones for 15 min before the procedure, whereas the control group rested for 15 min. Blood pressure (BP), heart rate, respiratory rate, and anxiety level were measured immediately before and after the intervention.

Conditions

Music; Anxiety

Keywords

music; anxiety; digestive tract endoscopy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Anxiety after intervention immediately

  Anxiety was measured using the Chinese version of the 20-item State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), which demonstrated high reliability (Cronbach's alpha of 0.91) in patients with anxiety disorders.32 Total scores for state anxiety ranged from 20 to 80; higher scores indicated higher levels of anxiety.

  baseline, 15 minute

Secondary Outcomes (3)

• Change from Baseline Blood pressure after intervention immediately

  baseline, 15 minute

• Change from Baseline Heart Rate after intervention immediately

  baseline, 15 minute

• Change from Baseline Respiratory Rate after intervention immediately

  baseline, 15 minute

Study Arms (2)

listening music

EXPERIMENTAL

The participants in the music group selected the music they preferred from different genres. During the 15-min intervention period before the gastroscopy procedure, the experimental group rested by listening to music and sitting on a comfortable chair

Behavioral: Music listening

Control

NO INTERVENTION

control group rested only by sitting on a comfortable chair

Interventions

Music listening BEHAVIORAL

listening the music 15 min

listening music

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• able to respond to questionnaires in Chinese. were excluded from the study.

You may not qualify if:

• with hearing loss who did not wear hearing aids
• patients who were unable to communicate verbally
• patients diagnosed with dementia, mental illness defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, or cognitive impairment

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 22, 2018
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: June 30, 2009
• Last Updated: August 22, 2018

Record last verified: 2018-08