ColonoscopyNCT05378165
Three Distraction Methods for Pain Reduction During Colonoscopy
A study testing Music group, Stress ball group and Video group in people with Colonoscopy and Colon Disease, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Colon Disease
- What is being tested?
- Music group, Stress ball group and Video group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2022to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Distraction Methods for Pain Reduction During Colonoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain and Anxiety
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
Read the 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.
- Conditions
- Colonoscopy, Colon Disease
- Being tested
- Music group, Stress ball group, Video group, Control group
- Keywords
- pain, anxiety, music, stress ball, virtual reality, nursing
- Medical subject headings
- Colonic Diseases, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music groupOther
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
Stress ball groupOther
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".
Video groupOther
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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". Receives: 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. Receives: Other: Video group |
| Control group | Other | Standard colonoscopy was performed on the patients in the control group, without any additional intervention. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 to 20 min before colonoscopy
Before Colonoscopy 2
When the patient comes to the endoscopy unit Patient's systolic blood pressure (mmHg)
Measured: 5 to 20 min before colonoscopy
Before Colonoscopy 3
When the patient comes to the endoscopy unit Diastolic blood pressures (mmHg)
Measured: 5 to 20 min before colonoscopy
Before Colonoscopy 4
When the patient comes to the endoscopy unit Heart rate (per minute)
Measured: 5 to 20 min before colonoscopy
Before Colonoscopy 5
When the patient comes to the endoscopy unit Oxygen saturation (SpO2)
Measured: 5 to 20 min before colonoscopy
Before Colonoscopy 6
When the patient comes to the endoscopy unit Pain levels (measured The Visual Analog Scale)
Measured: 5 to 20 min before colonoscopy
During colonoscopy 1
Patien's systolic blood pressures (mmHg) (within 5 minutes of the colonoscopy procedure)
Measured: During colonoscopy
During colonoscopy 2
Patient's diastolic blood pressures(mmHg) (within 5 minutes of the colonoscopy procedure)
Measured: During colonoscopy
During colonoscopy 3
Patient's heart rate (per minute) (within 5 minutes of the colonoscopy procedure)
Measured: During colonoscopy
During colonoscopy 4
Oxygen saturation (within 5 minutes of the colonoscopy procedure)
Measured: 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"
Measured: During colonoscopy
Secondary outcomes (6)
After colonoscopy 1
Patient systolic blood pressures (mmHg) (10 minutes after colonoscopy)
Measured: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 2
diastolic blood pressures(mmHg) (10 minutes after colonoscopy)
Measured: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 3
heart rate (per minute) (10 minutes after colonoscopy)
Measured: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 4
Oxygen saturation (10 minutes after colonoscopy)
Measured: 10-15 min after the colonoscopy procedure was complete.
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"
Measured: 10-15 min after the colonoscopy procedure was complete.
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.
Measured: 10-15 min after the colonoscopy procedure was complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start7 Feb 2022
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, open-label, randomized, parallel-group trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Karaveli Çakır, Kastamonu University
- Investigators
- Selda Karaveli Çakır, PhD, Principal investigator, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378165
- Sponsor's protocol ID
- 2020-KAEK-143-146
- Status last verified
- Mar 2023
- First submitted
- 29 Apr 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32056820Hudson 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.
PubMed 25641687Bashiri 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.
PubMed 30260780Sargin 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.
PubMed 27147784Sorkpor 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.
PubMed 33994100Karaveli 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.
PubMed 34231475
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Distraction Methods for Pain Reduction During Colonoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain and Anxiety
- ClinicalTrials.gov ID
- NCT05378165
- Acronym / sponsor ID
- 2020-KAEK-143-146
- Conditions
- Colonoscopy, Colon Disease
- Keywords
- pain, anxiety, music, stress ball, virtual reality, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Single centre, open-label, randomized, parallel-group trial
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: Music groupThe 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. |
| Stress ball group | Experimental | Other: Stress ball groupThe 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". |
| Video group | Experimental | Other: Video groupThe 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. |
| Control group | Other | Other: Control groupStandard colonoscopy was performed on the patients in the control group, without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music groupThe 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 | Music group |
| Stress ball groupThe 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 | Stress ball group |
| Video groupThe 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 | Video group |
| Control groupThe 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. | Other | Control group |
Primary outcome
Before Colonoscopy 1
Time frame: 5 to 20 min before colonoscopy
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
Time frame: 5 to 20 min before colonoscopy
When the patient comes to the endoscopy unit Patient's systolic blood pressure (mmHg)
Before Colonoscopy 3
Time frame: 5 to 20 min before colonoscopy
When the patient comes to the endoscopy unit Diastolic blood pressures (mmHg)
Before Colonoscopy 4
Time frame: 5 to 20 min before colonoscopy
When the patient comes to the endoscopy unit Heart rate (per minute)
Before Colonoscopy 5
Time frame: 5 to 20 min before colonoscopy
When the patient comes to the endoscopy unit Oxygen saturation (SpO2)
Before Colonoscopy 6
Time frame: 5 to 20 min before colonoscopy
When the patient comes to the endoscopy unit Pain levels (measured The Visual Analog Scale)
During colonoscopy 1
Time frame: During colonoscopy
Patien's systolic blood pressures (mmHg) (within 5 minutes of the colonoscopy procedure)
During colonoscopy 2
Time frame: During colonoscopy
Patient's diastolic blood pressures(mmHg) (within 5 minutes of the colonoscopy procedure)
During colonoscopy 3
Time frame: During colonoscopy
Patient's heart rate (per minute) (within 5 minutes of the colonoscopy procedure)
During colonoscopy 4
Time frame: During colonoscopy
Oxygen saturation (within 5 minutes of the colonoscopy procedure)
During colonoscopy 5
Time frame: During colonoscopy
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"
6 secondary outcomes
After colonoscopy 1
Time frame: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 2
Time frame: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 3
Time frame: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 4
Time frame: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 5
Time frame: 10-15 min after the colonoscopy procedure was complete.
After colonoscopy 6
Time frame: 10-15 min after the colonoscopy procedure was complete.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 32056820Celebi 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.
- Background: PubMed 25641687Hudson 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.
- Background: PubMed 30260780Bashiri 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.
- Background: PubMed 27147784Sargin 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 publication: PubMed 33994100Sorkpor 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 publication: PubMed 34231475Karaveli 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.
- Individual participant dataSharing planned: No
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Active, not recruiting
IMProving Adherence to Colonoscopy Through Teams and Technology
Colon Cancer, Cancer Colorectal
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
Active, not recruiting
Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Gastrointestinal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Karaveli Çakır, PhD principal investigator
Kastamonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music group, Stress ball group and Video group in people with Colonoscopy and Colon Disease, run by Kastamonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Before Colonoscopy 1 (time frame: 5 to 20 min before colonoscopy). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378165, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.