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Completed

NCT Number: NCT06669338

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

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

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Key information

Conditions

Colonoscopy Anxiety Anxiety Disorders Fear Mental Disorders Music Therapy White Noise the Elderly

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mugla, Muğla, Mentese, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Other

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

listen to white noise

Other

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

listen to hospital ambient sound

Other

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

Primary outcomes

  1. 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

  1. diastolic blood pressure

    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.

  2. Visual Analog Scale (VAS)

    Time frame: 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.

  3. The State-Trait Anxiety Inventory (STAI-I)

    Time frame: 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.

  4. heart 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.

  5. SpO2: peripheral oxygen saturation (%)

    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.

  6. systolic blood pressure

    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.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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