Effects of Music Therapy and White Noise on Pre-procedural Fear, Anxiety by Elderly Colonoscopy Patients

Not Applicable

Completed

• Conditions: Colonoscopy; the Elderly; White Noise; Music Therapy; Fear; Anxiety

• Registration Number: NCT06669338
• Lead Sponsor: Muğla Sıtkı Koçman University

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.

Study Timeline

• Study Start: 2024-10-25
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-30
• Status Verified: 2024-11
• Study First Posted: 2024-11-01
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-25
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. The one to be colonoscoped,
2. 65 years of age or older,
3. Participated in the research voluntarily
4. No vision, hearing and perception problems,
5. No communication problems (able to speak Turkish),
6. Those who are hemodynamically stable before colonoscopy,
7. No psychiatric diagnosis, no use of antidepressants, anxiolytics and sedative agents,
8. No analgesic or anesthetic medication 24 hours before the procedure.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
respiratory rate	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 Outcome Measures

Name	Time	Method
diastolic blood pressure	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.
Visual Analog Scale (VAS)	20 minutes of music therapy, white noise and ambient sound before a colonoscopy.	Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
The State-Trait Anxiety Inventory (STAI-I)	20 minutes of music therapy, white noise and ambient sound before colonoscopy.	The scale is administered before colonoscopy, at the beginning and at the end of the music therapy, white noise and ambient sound listening intervention.
heart rate	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.
SpO2: peripheral oxygen saturation (%)	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.
systolic blood pressure	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.

Trial Locations

Locations (1)

Mugla; 🇹🇷 Muğla, Turkey