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Completed

NCT Number: NCT06187233

The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation

The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation

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Key information

Conditions

Anxiety State Anxiety Disorders Behavior Health Behavior Mental Disorders Patient Satisfaction Tolerance Treatment Adherence and Compliance

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, 06200, Turkey (Türkiye)

About this study

It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 18-70 years old who had scheduled colonoscopy appointments

Exclusion criteria

  • Anxiety and panic disorders
  • Urgent endoscopic intervention
  • Advanced dementia
  • Hearing problems
  • Anatomical or inflammatory disorders in the external ear canals

Treatment and study plan

binaural music

Other

In the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied during the procedure.

Primary outcomes

  1. VAS-anxiety

    Time frame: immediately before being taken into the procedure room and 5 minutes after the procedure

    The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety

  2. VAS-pain

    Time frame: 5 minutes after the procedure

    The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety

  3. The Modified Gloucester Comfort Scale

    Time frame: During the procedure

    The endoscopy nurse recorded and analyzed data related to patient comfort, encompassing compliance and tolerance during the procedure, using the Modified Gloucester Comfort Scale.Discomfort, characterized by severe belching, retching, coughing, and non-compliance, was assessed on a scale where the absence of discomfort received a score of 1 point, while extreme discomfort during the procedure was assigned 5 points.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 5 minutes after the procedure

    After the procedure, the patients were asked a series of questions for procedure evaluation (worse than expected, as expected, better than expected) and their willingness to have endoscopy again for their health (no, yes). The binaural music group was asked a three-item question with "yes-not sure-no" responses, inquiring whether the music increased relaxation and if they would like to listen to the same music again during a repeat procedure.

  2. Heart rate

    Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure

    The comparison of heart rate in the music and control groups

  3. Blood pressure

    Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure

    The comparison of systolic and diastolic blood pressure in the music and control groups

  4. cecal insertion time(minutes)

    Time frame: during the procedure

    Insertion time, as defined, refers to the duration between the initiation of the colonoscopy procedure and the moment when the endoscope reaches the cecum, with identification of the appendiceal orifice.

  5. withdrawal time (minutes)

    Time frame: during the procedure

    Withdrawal time, as defined, refers to the period between the commencement of withdrawing the colonoscope from the cecum and the complete removal of the colonoscope from the patient.

  6. polyp detection rate

    Time frame: during the procedure

    It will be assessed by recording the encountered polyps during colonoscopy.

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2024
Registry last updated
Jan 2, 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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