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NCT Number: NCT04641052

The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

This study aims to investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.

The study will be conducted with two groups: the intervention group (n=35) and the control group (n=35). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to music by the researchers for 15 minutes before the procedure.

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Key information

Conditions

Endoscopic Retrograde Cholangio-Pancreatography Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Sciences university Hospital

Afyonkarahisar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged 18 or above,
  • with a scheduled ERCP procedure
  • with the ASA grade level of I-II clinically
  • without a hearing/speech impairment
  • willing to participate in the research
  • without a mental problem or diagnosis of psychiatric disorder
  • without any a diagnosis of depression

Exclusion criteria

  • Patients with an emergency ERCP procedure
  • with a hearing/speech impairment
  • not willing to participate in the research
  • with a mental problem or diagnosis of psychiatric disorder
  • with a diagnosis of depression

Treatment and study plan

Music listening

Other

The music type will be chosen by the patients and researchers will not have any influence on their choices.

Primary outcomes

  1. Visual Analog Scale for Anxiety (VAS-A)

    Time frame: 1 Hour

    VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety"

  2. Visual Analog Scale for Pain (VAS)

    Time frame: 2 Hours

    VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.

Secondary outcomes

  1. Vital Signs

    Time frame: 4 Hours

    The systolic and diastolic blood pressure will be measured with " MICROLIFE BP A 150 AFIB" device by the researchers.

  2. Vital Signs

    Time frame: 4 hours

    Heart rate values of the patients will be measured with a finger type oximeter by the researchers.

  3. Vital Signs

    Time frame: 4 hours

    SpO2 values of the patients will be measured with a finger type oximeter by the researchers.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
Jan 4, 2023

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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