Three Distraction Methods for Pain Reduction During Colonoscopy

NCT05378165 | Completed

• 1 other identifier: 2020-KAEK-143-146
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain; anxiety; music; stress ball; virtual reality; nursing

Outcome Measures

Primary Outcomes (11)

• Before Colonoscopy 1

  When the patient comes to the endoscopy unit State anxiety levels (measured The State Anxiety Inventory) The State Anxiety Inventory requires individuals to described heir feelings at a specific moment under specific circumstances. Scores on the entire scale range from 20 to 80, with higher scores indicating higher anxiety levels.

  5 to 20 min before colonoscopy

• Before Colonoscopy 2

  When the patient comes to the endoscopy unit Patient's systolic blood pressure (mmHg)

  5 to 20 min before colonoscopy

• Before Colonoscopy 3

  When the patient comes to the endoscopy unit Diastolic blood pressures (mmHg)

  5 to 20 min before colonoscopy

• Before Colonoscopy 4

  When the patient comes to the endoscopy unit Heart rate (per minute)

  5 to 20 min before colonoscopy

• Before Colonoscopy 5

  When the patient comes to the endoscopy unit Oxygen saturation (SpO2)

  5 to 20 min before colonoscopy

• Before Colonoscopy 6

  When the patient comes to the endoscopy unit Pain levels (measured The Visual Analog Scale)

  5 to 20 min before colonoscopy

• During colonoscopy 1

  Patien's systolic blood pressures (mmHg) (within 5 minutes of the colonoscopy procedure)

  During colonoscopy

• During colonoscopy 2

  Patient's diastolic blood pressures(mmHg) (within 5 minutes of the colonoscopy procedure)

  During colonoscopy

• During colonoscopy 3

  Patient's heart rate (per minute) (within 5 minutes of the colonoscopy procedure)

  During colonoscopy

• During colonoscopy 4

  Oxygen saturation (within 5 minutes of the colonoscopy procedure)

  During colonoscopy

• During colonoscopy 5

  Pain were measured (measured The Visual Analog Scale) (within 5 minutes of the colonoscopy procedure) Pain intensity is scored between 0-10, absence of pain is "0" point, whereas the most severe pain is scored "10"

  During colonoscopy

Secondary Outcomes (6)

• After colonoscopy 1

  10-15 min after the colonoscopy procedure was complete.

• After colonoscopy 2

  10-15 min after the colonoscopy procedure was complete.

• After colonoscopy 3

  10-15 min after the colonoscopy procedure was complete.

• After colonoscopy 4

  10-15 min after the colonoscopy procedure was complete.

• After colonoscopy 5

  10-15 min after the colonoscopy procedure was complete.

Study Arms (4)

Music group

EXPERIMENTAL

The music group listened to Acemasiran-type classical Turkish music with a headset from an MP3 player starting at about 10 min before colonoscopy until completion of the procedure.

Other: Music group

Stress ball group

EXPERIMENTAL

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: Stress ball group

Video group

EXPERIMENTAL

The patients in the 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: Video group

Control group

OTHER

Standard colonoscopy was performed on the patients in the control group, without any additional intervention.

Other: Control group

Interventions

Music group OTHER

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

Music group

Stress ball group OTHER

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".

Stress ball group

Video group OTHER

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.

Video group

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent colonoscopy without anesthesia
• Patients who were over 18 years of age
• Patients who did not have vision problems
• Patients who did not have hearing problems
• Patients who did not have cognitive problems

You may not qualify if:

• Patients who underwent colonoscopy with anesthesia
• Patients who were under 18 years of age
• Patients who have vision problems
• Patients who have hearing problems
• Patients who have cognitive problems

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Kastamonu University

Kastamonu, 37100, Turkey (Türkiye)

Location

Related Publications (6)

• Celebi D, Yilmaz E, Sahin ST, Baydur H. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101084. doi: 10.1016/j.ctcp.2019.101084. Epub 2019 Dec 23.

  PMID: 32056820 BACKGROUND

• Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.

  PMID: 25641687 BACKGROUND

• Bashiri M, Akcali D, Coskun D, Cindoruk M, Dikmen A, Cifdaloz BU. Evaluation of pain and patient satisfaction by music therapy in patients with endoscopy/colonoscopy. Turk J Gastroenterol. 2018 Sep;29(5):574-579. doi: 10.5152/tjg.2018.18200.

  PMID: 30260780 BACKGROUND

• Sargin M, Uluer MS, Aydogan E, Hanedan B, Tepe MI, Eryilmaz MA, Ebem E, Ozmen S. Anxiety Levels in Patients Undergoing Sedation for Elective Upper Gastrointestinal Endoscopy and Colonoscopy. Med Arch. 2016 Apr;70(2):112-5. doi: 10.5455/medarh.2016.70.112-115. Epub 2016 Apr 1.

  PMID: 27147784 BACKGROUND

• Sorkpor SK, Johnson CM, Santa Maria DM, Miao H, Moore C, Ahn H. The Effect of Music Listening on Pain in Adults Undergoing Colonoscopy: A Systematic Review and Meta-Analysis. J Perianesth Nurs. 2021 Oct;36(5):573-580.e1. doi: 10.1016/j.jopan.2020.12.012. Epub 2021 May 12.

  PMID: 33994100 RESULT

• Karaveli Cakir S, Evirgen S. The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial. Turk J Gastroenterol. 2021 May;32(5):451-457. doi: 10.5152/tjg.2021.191081.

  PMID: 34231475 RESULT

MeSH Terms

Conditions

Colonic Diseases; Pain; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Selda Karaveli Çakır, PhD

  Kastamonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: While participants and researchers were not blinded to group allocation, the biostatistician remained blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Single centre, open-label, randomized, parallel-group trial

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 18, 2022
• Study Start: February 7, 2022
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)