Three Distraction Methods for Pain Reduction During Colonoscopy

NCT05378165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-15

No results posted yet for this study

Summary

Colonoscopy is a common procedure to evaluate the gastrointestinal tract. The colonoscopy procedure can sometimes be uncomfortable and painful for the patient.

The aim of this study was to compare the effects on pain and anxiety of distraction methods used during colonoscopy. Single centre, randomized, parallel-group trial.

Endoscopy unit of a training and research hospital in northern Turkey A total of 120 patients were recruited and randomized into four groups as music, stress ball, video, and control group. The data were collected using Visual Analog Scale for pain and satisfaction, State-Trait Anxiety Inventory for anxiety, and hemodynamic parameters.

Data collection continues

Conditions

  • Colonoscopy
  • Colon Disease

Interventions

OTHER

Music group

The study was divided into three stages; before; during; and after colonoscopy. Patient's hemodynamics parameters, including systolic and diastolic blood pressures, heart rate, and oxygen saturation, were measured about 5 to 10 min before, during and within 10 min after the colonoscopy procedure was complete. All of the patients who participated in the study underwent the standard protocol used in the Endoscopy Unit of our institution. Colonoscopy was performed on patients in all groups without the use of anesthesia. After positioning the patients in the left lateral position for the colonoscopy procedure, and vemcain local anesthetic and vaseline was applied to the anal area before starting colonoscopy using a Fujinon flexible colonoscope. The music group listened to Acemasiran-type classical Turkish music.Acemasiran-type music affects the human brain and provides a sense of creativity to people. This musical tone has pain- relieving and antispasmodic

OTHER

Stress ball group

The study was divided into three stages; before; during; and after colonoscopy. Patient's hemodynamics parameters, including systolic and diastolic blood pressures, heart rate, and oxygen saturation, were measured about 5 to 10 min before, during and within 10 min after the colonoscopy procedure was complete. Colonoscopy was performed on patients in all groups without the use of anesthesia. After positioning the patients in the left lateral position for the colonoscopy procedure, and vemcain local anesthetic and vaseline was applied to the anal area before starting colonoscopy using a Fujinon flexible colonoscope. The stress ball group was given stress balls which was medium hard and made of high-quality silicone approximately 10 minutes before colonoscopy. The patients in stress ball group were instructed to "squeeze the balls twice after counting up to five" and "repeat until the end of the entire procedure".

OTHER

Video group

The study was divided into three stages; before; during; and after colonoscopy. Patient's hemodynamics parameters, including systolic and diastolic blood pressures, heart rate, and oxygen saturation, were measured about 5 to 10 min before, during and within 10 min after the colonoscopy procedure was complete. All of the patients who participated in the study underwent the standard protocol used in the Endoscopy Unit of our institution. Colonoscopy was performed on patients in al groups without the use of anesthesia. After positioning the patients in the left lateral position for the colonoscopy procedure, and vemcain local anesthetic and vaseline was applied to the anal area before starting colonoscopy using a Fujinon flexible colonoscope. Video group allowed to watch a licensed virtual reality application,"A walk on the beach", through an Android mobile phone placed in Cardboard Super Flex Goggles, started 10 minute before the colonoscopy until the procedure was completed.

OTHER

Control group

The study was divided into three stages; (1) before; (2) during; and (3) after colonoscopy. Patient's hemodynamics parameters, including systolic and diastolic blood pressures, heart rate, and oxygen saturation, were measured about 5 to 10 min before, during and within 10 min after the colonoscopy procedure was complete. All of the patients who participated in the study underwent the standard protocol used in the Endoscopy Unit of our institution. Colonoscopy was performed on patients in al groups without the use of anesthesia. After positioning the patients in the left lateral position for the colonoscopy procedure, and vemcain local anesthetic and vaseline was applied to the anal area before starting colonoscopy using a Fujinon flexible colonoscope. Control group, without any additional intervention.

Sponsors & Collaborators

  • Kastamonu University

    lead OTHER

Principal Investigators

  • Selda Karaveli Çakır, PhD · Kastamonu University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2022-05-30
Completion
2022-05-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378165 on ClinicalTrials.gov