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

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety; Colonoscopy; Fear; Music Therapy; the Elderly; White Noise
• Intervention / Treatment: Other: Music therapy; Other: listen to white noise; Other: listen to hospital ambient sound

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muğla, Turkey, 48000
    • Muğla
  • Mentese
    • Mugla, Mentese, Turkey, 48000
      • Muğla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: music therapy group; The group that listened to music for 20 minutes before the colonoscopy	Other: Music therapy; patients listen to music for 20 minutes with headphones before colonoscopy.
Experimental: white noise group; The group that listened to white noise for 20 minutes before the colonoscopy	Other: listen to white noise; patients listen to white noise with headphones for 20 minutes before colonoscopy.
Placebo Comparator: control group; The group that listened to recorded ambient sound for 20 minutes before the colonoscopy.	Other: listen to hospital ambient sound; patients listen to recorded ambient sound for 20 minutes with headphones before colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory rate	Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.	20 minutes of music therapy, white noise and ambient sound before colonoscopy.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Principal Investigator: Mehtap ÇULLU, PhD, Muğla Sıtkı Koçman University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Colonoscopy;anxiety;fear;vital signs;musictherapy;whitenoise
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MuglaSKU-HEM-MC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Taking time to share data and not having the time to do so,

There is no benefit in sharing data,

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No