Colonoscopy Clinical Trial
Official title:
Three Distraction Methods for Pain Reduction During Colonoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain and Anxiety
Verified date | March 2023 |
Source | Kastamonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | May 30, 2022 |
Est. primary completion date | May 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Kastamonu University | Kastamonu |
Lead Sponsor | Collaborator |
---|---|
Kastamonu University |
Turkey,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Before Colonoscopy 2 | When the patient comes to the endoscopy unit Patient's systolic blood pressure (mmHg) | 5 to 20 min before colonoscopy | |
Primary | Before Colonoscopy 3 | When the patient comes to the endoscopy unit Diastolic blood pressures (mmHg) | 5 to 20 min before colonoscopy | |
Primary | Before Colonoscopy 4 | When the patient comes to the endoscopy unit Heart rate (per minute) | 5 to 20 min before colonoscopy | |
Primary | Before Colonoscopy 5 | When the patient comes to the endoscopy unit Oxygen saturation (SpO2) | 5 to 20 min before colonoscopy | |
Primary | Before Colonoscopy 6 | When the patient comes to the endoscopy unit Pain levels (measured The Visual Analog Scale) | 5 to 20 min before colonoscopy | |
Primary | During colonoscopy 1 | Patien's systolic blood pressures (mmHg) (within 5 minutes of the colonoscopy procedure) | During colonoscopy | |
Primary | During colonoscopy 2 | Patient's diastolic blood pressures(mmHg) (within 5 minutes of the colonoscopy procedure) | During colonoscopy | |
Primary | During colonoscopy 3 | Patient's heart rate (per minute) (within 5 minutes of the colonoscopy procedure) | During colonoscopy | |
Primary | During colonoscopy 4 | Oxygen saturation (within 5 minutes of the colonoscopy procedure) | During colonoscopy | |
Primary | 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 | After colonoscopy 1 | Patient systolic blood pressures (mmHg) (10 minutes after colonoscopy) | 10-15 min after the colonoscopy procedure was complete. | |
Secondary | After colonoscopy 2 | diastolic blood pressures(mmHg) (10 minutes after colonoscopy) | 10-15 min after the colonoscopy procedure was complete. | |
Secondary | After colonoscopy 3 | heart rate (per minute) (10 minutes after colonoscopy) | 10-15 min after the colonoscopy procedure was complete. | |
Secondary | After colonoscopy 4 | Oxygen saturation (10 minutes after colonoscopy) | 10-15 min after the colonoscopy procedure was complete. | |
Secondary | 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" | 10-15 min after the colonoscopy procedure was complete. | |
Secondary | 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. | 10-15 min after the colonoscopy procedure was complete. |
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