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

NCT ID: NCT06669338

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2024-11-25

Brief Summary

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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

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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.

Conditions

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Colonoscopy the Elderly White Noise Music Therapy Fear Anxiety

Keywords

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Colonoscopy;anxiety;fear;vital signs;musictherapy;whitenoise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

experimental study with three groups.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
results evaluator

Study Groups

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music therapy group

The group that listened to music for 20 minutes before the colonoscopy

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

patients listen to music for 20 minutes with headphones before colonoscopy.

white noise group

The group that listened to white noise for 20 minutes before the colonoscopy

Group Type EXPERIMENTAL

listen to white noise

Intervention Type OTHER

patients listen to white noise with headphones for 20 minutes before colonoscopy.

control group

The group that listened to recorded ambient sound for 20 minutes before the colonoscopy.

Group Type PLACEBO_COMPARATOR

listen to hospital ambient sound

Intervention Type OTHER

patients listen to recorded ambient sound for 20 minutes with headphones before colonoscopy.

Interventions

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Music therapy

patients listen to music for 20 minutes with headphones before colonoscopy.

Intervention Type OTHER

listen to white noise

patients listen to white noise with headphones for 20 minutes before colonoscopy.

Intervention Type OTHER

listen to hospital ambient sound

patients listen to recorded ambient sound for 20 minutes with headphones before colonoscopy.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Mehtap Cullu

Phd lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehtap ÇULLU, PhD

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Locations

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Mugla

Muğla, Mentese, Turkey (Türkiye)

Site Status

Mugla

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MuglaSKU-HEM-MC-01

Identifier Type: -

Identifier Source: org_study_id