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Three Distraction Methods for Pain Reduction During Colonoscopy

Primary Purpose

Colonoscopy, Colon Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music group
Stress ball group
Video group
Control group
Sponsored by
Kastamonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonoscopy focused on measuring pain, anxiety, music, stress ball, virtual reality, nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Kastamonu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Music group

Stress ball group

Video group

Control group

Arm Description

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.

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".

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.

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

Outcomes

Primary Outcome Measures

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.
Before Colonoscopy 2
When the patient comes to the endoscopy unit Patient's systolic blood pressure (mmHg)
Before Colonoscopy 3
When the patient comes to the endoscopy unit Diastolic blood pressures (mmHg)
Before Colonoscopy 4
When the patient comes to the endoscopy unit Heart rate (per minute)
Before Colonoscopy 5
When the patient comes to the endoscopy unit Oxygen saturation (SpO2)
Before Colonoscopy 6
When the patient comes to the endoscopy unit Pain levels (measured The Visual Analog Scale)
During colonoscopy 1
Patien's systolic blood pressures (mmHg) (within 5 minutes of the colonoscopy procedure)
During colonoscopy 2
Patient's diastolic blood pressures(mmHg) (within 5 minutes of the colonoscopy procedure)
During colonoscopy 3
Patient's heart rate (per minute) (within 5 minutes of the colonoscopy procedure)
During colonoscopy 4
Oxygen saturation (within 5 minutes of the colonoscopy procedure)
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"

Secondary Outcome Measures

After colonoscopy 1
Patient systolic blood pressures (mmHg) (10 minutes after colonoscopy)
After colonoscopy 2
diastolic blood pressures(mmHg) (10 minutes after colonoscopy)
After colonoscopy 3
heart rate (per minute) (10 minutes after colonoscopy)
After colonoscopy 4
Oxygen saturation (10 minutes after colonoscopy)
After colonoscopy 5
pain were measured (measured The Visual Analog Scale) (10 minutes after colonoscopy) Pain intensity is scored between 0-10, absence of pain is "0" point, whereas the most severe pain is scored "10"
After colonoscopy 6
State anxiety levels (measured The State Anxiety Inventory) (15 minutes after colonoscopy procedure) evaluated. 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.

Full Information

First Posted
April 29, 2022
Last Updated
March 14, 2023
Sponsor
Kastamonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05378165
Brief Title
Three Distraction Methods for Pain Reduction During Colonoscopy
Official Title
Three Distraction Methods for Pain Reduction During Colonoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kastamonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Colonoscopy is one of the endoscopic procedures used for the diagnostic and interventional procedures of the intestines. Compared to other radiological imaging methods, the most important advantage of colonoscopy is that it can be used to evaluate symptoms and complaints as well as to obtain a biopsy when a differential diagnosis is needed. In recent years, therefore, colonoscopy has been recognized as the gold standard for colon cancer screening. Most patients consider colonoscopy a painful and uncomfortable procedure. Studies revealed that patients experience moderate anxiety during the colonoscopy procedure. The reflex spasm resulting from stimulation of the colon in order to obtain a better image during colonoscopy, and acute distension resulting from flatulence may cause patients to experience pain during and after the procedure. Studies have shown that patients experience pain and anxiety during the colonoscopy procedure. The pain and anxiety that patients experience is not only related to the procedure, but also to the stress of the likelihood of getting cancer over time. Performing colonoscopy under sedation is widely used in clinical practice. However, sedation increases complications associated with colonoscopy, and has potential risks, such as hypoxemia, hypoventilation, aspiration pneumonia, pulmonary embolism and myocardial infarction. Different drug regimens are used to manage pain during colonoscopy; however, the optimal regime is still debated. In recent years, in addition to pharmacological methods, non-pharmacological methods such as distraction applications such as music and virtual reality have been used to reduce anxiety and pain during the colonoscopy procedure.There are randomized controlled studies showing that simple distraction methods used during the colonoscopy procedure reduce pain and anxiety.Although there are few studies comparing the effectiveness of multiple simple distraction methods such as music, stress ball, and video on pain and anxiety during painful procedures, there are no studies in the literature comparing the effects of three different distraction methods during the colonoscopy procedure. 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. The patients who met the inclusion criteria were assigned to one of four groups: (1) music; (2) stress ball; (3) video or (4) control group. The patients who met the inclusion criteria were assigned to one of four groups: (1) music; (2) stress ball; (3) video or (4) control group. 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. Acemasiran-type music affects the human brain and provides a sense of creativity to people. This musical tone has pain- relieving and antispasmodic 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". 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. Standard colonoscopy was performed on the patients in the control group, without any additional intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Colon Disease
Keywords
pain, anxiety, music, stress ball, virtual reality, nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single centre, open-label, randomized, parallel-group trial
Masking
Outcomes Assessor
Masking Description
While participants and researchers were not blinded to group allocation, the biostatistician remained blinded.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music group
Arm Type
Experimental
Arm Description
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.
Arm Title
Stress ball group
Arm Type
Experimental
Arm Description
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".
Arm Title
Video group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Standard colonoscopy was performed on the patients in the control group, without any additional intervention.
Intervention Type
Other
Intervention Name(s)
Music group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Stress ball group
Intervention Description
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".
Intervention Type
Other
Intervention Name(s)
Video group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Before Colonoscopy 1
Description
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.
Time Frame
5 to 20 min before colonoscopy
Title
Before Colonoscopy 2
Description
When the patient comes to the endoscopy unit Patient's systolic blood pressure (mmHg)
Time Frame
5 to 20 min before colonoscopy
Title
Before Colonoscopy 3
Description
When the patient comes to the endoscopy unit Diastolic blood pressures (mmHg)
Time Frame
5 to 20 min before colonoscopy
Title
Before Colonoscopy 4
Description
When the patient comes to the endoscopy unit Heart rate (per minute)
Time Frame
5 to 20 min before colonoscopy
Title
Before Colonoscopy 5
Description
When the patient comes to the endoscopy unit Oxygen saturation (SpO2)
Time Frame
5 to 20 min before colonoscopy
Title
Before Colonoscopy 6
Description
When the patient comes to the endoscopy unit Pain levels (measured The Visual Analog Scale)
Time Frame
5 to 20 min before colonoscopy
Title
During colonoscopy 1
Description
Patien's systolic blood pressures (mmHg) (within 5 minutes of the colonoscopy procedure)
Time Frame
During colonoscopy
Title
During colonoscopy 2
Description
Patient's diastolic blood pressures(mmHg) (within 5 minutes of the colonoscopy procedure)
Time Frame
During colonoscopy
Title
During colonoscopy 3
Description
Patient's heart rate (per minute) (within 5 minutes of the colonoscopy procedure)
Time Frame
During colonoscopy
Title
During colonoscopy 4
Description
Oxygen saturation (within 5 minutes of the colonoscopy procedure)
Time Frame
During colonoscopy
Title
During colonoscopy 5
Description
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"
Time Frame
During colonoscopy
Secondary Outcome Measure Information:
Title
After colonoscopy 1
Description
Patient systolic blood pressures (mmHg) (10 minutes after colonoscopy)
Time Frame
10-15 min after the colonoscopy procedure was complete.
Title
After colonoscopy 2
Description
diastolic blood pressures(mmHg) (10 minutes after colonoscopy)
Time Frame
10-15 min after the colonoscopy procedure was complete.
Title
After colonoscopy 3
Description
heart rate (per minute) (10 minutes after colonoscopy)
Time Frame
10-15 min after the colonoscopy procedure was complete.
Title
After colonoscopy 4
Description
Oxygen saturation (10 minutes after colonoscopy)
Time Frame
10-15 min after the colonoscopy procedure was complete.
Title
After colonoscopy 5
Description
pain were measured (measured The Visual Analog Scale) (10 minutes after colonoscopy) Pain intensity is scored between 0-10, absence of pain is "0" point, whereas the most severe pain is scored "10"
Time Frame
10-15 min after the colonoscopy procedure was complete.
Title
After colonoscopy 6
Description
State anxiety levels (measured The State Anxiety Inventory) (15 minutes after colonoscopy procedure) evaluated. 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.
Time Frame
10-15 min after the colonoscopy procedure was complete.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda Karaveli Çakır, PhD
Organizational Affiliation
Kastamonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kastamonu University
City
Kastamonu
ZIP/Postal Code
37100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32056820
Citation
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.
Results Reference
background
PubMed Identifier
25641687
Citation
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.
Results Reference
background
PubMed Identifier
30260780
Citation
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.
Results Reference
background
PubMed Identifier
27147784
Citation
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.
Results Reference
background
PubMed Identifier
33994100
Citation
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.
Results Reference
result
PubMed Identifier
34231475
Citation
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.
Results Reference
result

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Three Distraction Methods for Pain Reduction During Colonoscopy

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