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Clinical Trials/NCT06669338
NCT06669338
Completed
Not Applicable

The Effect of Music Therapy and White Noise on Pre-procedural Fear, Anxiety and Vital Signs of Elderly Colonoscopy Patients: A Double-Blind Randomized Controlled Trial

Muğla Sıtkı Koçman University1 site in 1 country90 target enrollmentOctober 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonoscopy
Sponsor
Muğla Sıtkı Koçman University
Enrollment
90
Locations
1
Primary Endpoint
respiratory rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy.

The study was a double-blind, pre-test and post-test

Detailed Description

Colonoscopy patients experience high levels of fear and anxiety due to the procedure. Fear and anxiety can activate the patient's autonomic nervous system, leading to increased sweating, increased heart rate, blood pressure and respiratory rate, and procedure-related complications. Reducing fear and anxiety and relaxing the patient not only prevents potential harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to investigate the effects of music therapy and white noise listening on the fear, anxiety and vital signs of patients undergoing colonoscopy.

Registry
clinicaltrials.gov
Start Date
October 25, 2024
End Date
November 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Muğla Sıtkı Koçman University
Responsible Party
Principal Investigator
Principal Investigator

Mehtap Cullu

Phd lecturer

Muğla Sıtkı Koçman University

Eligibility Criteria

Inclusion Criteria

  • The one to be colonoscoped,
  • 65 years of age or older,
  • Participated in the research voluntarily
  • No vision, hearing and perception problems,
  • No communication problems (able to speak Turkish),
  • Those who are hemodynamically stable before colonoscopy,
  • No psychiatric diagnosis, no use of antidepressants, anxiolytics and sedative agents,
  • No analgesic or anesthetic medication 24 hours before the procedure.

Exclusion Criteria

  • Developing complications during the procedure,
  • Removing the headset during the procedure,
  • Participants with visual and hearing impairment or a medical history of dementia, cognitive impairments or psychiatric disorders
  • The general condition deteriorated during the procedure or a different intervention was performed with anesthesia,
  • Who wants to leave the study on their own accord.

Outcomes

Primary Outcomes

respiratory rate

Time Frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.

Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.

Secondary Outcomes

  • diastolic blood pressure(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • Visual Analog Scale (VAS)(20 minutes of music therapy, white noise and ambient sound before a colonoscopy.)
  • The State-Trait Anxiety Inventory (STAI-I)(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • heart rate(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • SpO2: peripheral oxygen saturation (%)(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • systolic blood pressure(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)

Study Sites (1)

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