Colonoscopy (Procedure)NCT07664800
Online Nursing Counseling and Colonoscopy Outcomes
A study testing Online Nursing Counseling in people with Colonoscopy (Procedure) and 18 Years and Over, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study was conducted in the endoscopy unit of a private hospital between March and June 2023 to evaluate the effect of nurse-delivered counseling on pain, anxiety, and comfort levels in patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy (Procedure), 18 Years and Over, Literacy
- What is being tested?
- Online Nursing Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Literate
- No communication or hearing impairment
- Conscious and able to respond to questions
- Scheduled for colonoscopy
- Not using regular analgesic or antidepressant medications
Show all 13Show fewer
- Voluntary participation
- No prior colonoscopy
- No diagnosis of colorectal cancer
- No diagnosis of inflammatory bowel disease
- No diagnosis of Crohn's disease
- Access to the internet and a smartphone, tablet, or computer
- Able to use WhatsApp
Who cannot join
- Age <18 years
- Illiterate
- Presence of communication or hearing impairment
- Cognitive impairment or inability to provide informed consent
- Not scheduled for colonoscopy
- Regular use of analgesic or antidepressant medications
Show all 13Show fewer
- Refusal to participate
- History of prior colonoscopy
- Diagnosis of colorectal cancer
- Diagnosis of inflammatory bowel disease
- Diagnosis of Crohn's disease
- No access to the internet or lack of a smartphone, tablet, or computer
- Inability to use WhatsApp
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanko University Faculty of Health Sciences, Nursing Department
Gaziantep, Şehitkamil, 27090
About this study
Official title: The Effect of Nurse-Delivered Online Counseling on Invasive Pain, Anxiety, and Comfort Levels in Patients Undergoing Colonoscopy
This randomized controlled experimental study was conducted in the endoscopy unit of a private hospital between March and June 2023 to evaluate the effect of nurse-delivered counseling on pain, anxiety, and comfort levels in patients undergoing colonoscopy. Sixty patients were assigned to intervention (n=30) and control (n=30) groups. The intervention group received counseling beginning 24 hours before the procedure, including face-to-face education, telephone support, and reminder messages, while the control group received routine care. Anxiety was assessed using the State Anxiety Scale, and pain and comfort were evaluated using the Visual Analog Scale.
Read the detailed description
This randomized controlled experimental study was conducted in the endoscopy unit of a private hospital between March 2023 and June 2023. The study was designed to evaluate the effect of nurse-delivered online counseling on pain, anxiety, and comfort levels in patients undergoing colonoscopy. Sixty eligible patients were assigned to either an intervention group (n=30) or a control group (n=30) using the minimization method. Patients in the intervention group received online counseling based on standard colonoscopy preparation materials beginning approximately 24 hours before the procedure, including face-to-face education, telephone support, and reminder messages. Patients in the control group received routine care only. Anxiety was assessed using the State-Trait Anxiety Inventory, while pain and comfort were evaluated using the Visual Analog Scale. Outcome measures were collected before and after the colonoscopy procedure.
- Conditions
- Colonoscopy (Procedure), 18 Years and Over, Literacy, No Communication Difficulties, Orientation, Colonoscopy Preparation Acceptance
- Being tested
- Online Nursing Counseling
- Keywords
- colonoscopy, nursing, pain, anxiety, comfort
- Medical subject headings
- Literacy, Orientation, Spatial, Cell Phone Use, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Nursing CounselingOther
Participants received nurse-delivered online counseling based on standard colonoscopy preparation materials. The intervention started approximately 24 hours before the procedure and included an initial face-to-face education session, followed by 24-hour telephone support and reminder messages. Participants were also able to contact the nurse for questions during this period.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients receiving routine care without additional counseling |
| Intervention | Experimental | Patients receiving nurse-delivered online counseling before colonoscopy Receives: Other: Online Nursing Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level
Measured using the State-Trait Anxiety Inventory (State Anxiety Scale; score range 20-80, higher scores indicate higher anxiety).
Measured: Before and after colonoscopy procedure (same day)
Secondary outcomes (2)
Pain Level
Measured using the Visual Analog Scale (VAS), a self-reported scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Before and after colonoscopy procedure (same day)
Comfort Level
Measured using the Visual Analog Scale (VAS), a self-reported scale ranging from 0 to 10, where 0 indicates no comfort and 10 indicates maximum comfort. Higher scores indicate greater comfort.
Measured: Before and after colonoscopy procedure (same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Mar 2023
- Primary completion1 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy (Procedure)Studies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Bebek, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664800
- Sponsor's protocol ID
- SANKOU-HEMS-SBS-01
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to ethical and confidentiality considerations.
Publications
Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Richard Boland C, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2014 Oct;109(10):1528-45. doi: 10.1038/ajg.2014.272. Epub 2014 Sep 16. No abstract available.
PubMed 25223578Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep. 2020 May 6;22(6):28. doi: 10.1007/s11894-020-00764-4.
PubMed 32377915Shieh TY, Chen MJ, Chang CW, Hung CY, Hu KC, Kuo YC, Shih SC, Wang HY. Effect of physician-delivered patient education on the quality of bowel preparation for screening colonoscopy. Gastroenterol Res Pract. 2013;2013:570180. doi: 10.1155/2013/570180. Epub 2013 Dec 17.
PubMed 24454341Alvarez-Gonzalez MA, Pantaleon Sanchez MA, Bernad Cabredo B, Garcia-Rodriguez A, Frago Larramona S, Nogales O, Diez Redondo P, Puig Del Castillo I, Romero Mascarell C, Caballero N, Romero Sanchez-Miguel I, Perez Berbegal R, Hernandez Negrin D, Bujedo Sadornill G, Perez Oltra A, Casals Urquiza G, Amoros Martinez J, Seoane Urgorri A, Ibanez Zafon IA, Gimeno-Garcia AZ. Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial. Endoscopy. 2020 Nov;52(11):1026-1035. doi: 10.1055/a-1178-9844. Epub 2020 Jun 17.
PubMed 32557475Elvas L, Brito D, Areia M, Carvalho R, Alves S, Saraiva S, Cadime AT. Impact of Personalised Patient Education on Bowel Preparation for Colonoscopy: Prospective Randomised Controlled Trial. GE Port J Gastroenterol. 2017 Jan;24(1):22-30. doi: 10.1159/000450594. Epub 2016 Nov 1.
PubMed 28848777Kurlander JE, Sondhi AR, Waljee AK, Menees SB, Connell CM, Schoenfeld PS, Saini SD. How Efficacious Are Patient Education Interventions to Improve Bowel Preparation for Colonoscopy? A Systematic Review. PLoS One. 2016 Oct 14;11(10):e0164442. doi: 10.1371/journal.pone.0164442. eCollection 2016.
PubMed 27741260Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
PubMed 30385831Yılmaz E, Aslan A, Ergın E. Kolonoskopi Yapılacak Hastalarda Bağırsak Temizliğine Öz Etkililik Düzeylerinin Etkisi. CBU-SBED. 2018;5(4):192-198.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Delivered Online Counseling on Invasive Pain, Anxiety, and Comfort Levels in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT07664800
- Acronym / sponsor ID
- SANKOU-HEMS-SBS-01
- Conditions
- Colonoscopy (Procedure), 18 Years and Over, Literacy, No Communication Difficulties, Orientation, Colonoscopy Preparation Acceptance
- Keywords
- colonoscopy, nursing, pain, anxiety, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Jun 2026 (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.
This randomized controlled experimental study was conducted in the endoscopy unit of a private hospital between March and June 2023 to evaluate the effect of nurse-delivered counseling on pain, anxiety, and comfort levels in patients undergoing colonoscopy. Sixty patients were assigned to intervention (n=30) and control (n=30) groups. The intervention group received counseling beginning 24 hours before the procedure, including face-to-face education, telephone support, and reminder messages, while the control group received routine care. Anxiety was assessed using the State Anxiety Scale, and pain and comfort were evaluated using the Visual Analog Scale.
Detailed description
This randomized controlled experimental study was conducted in the endoscopy unit of a private hospital between March 2023 and June 2023. The study was designed to evaluate the effect of nurse-delivered online counseling on pain, anxiety, and comfort levels in patients undergoing colonoscopy. Sixty eligible patients were assigned to either an intervention group (n=30) or a control group (n=30) using the minimization method. Patients in the intervention group received online counseling based on standard colonoscopy preparation materials beginning approximately 24 hours before the procedure, including face-to-face education, telephone support, and reminder messages. Patients in the control group received routine care only. Anxiety was assessed using the State-Trait Anxiety Inventory, while pain and comfort were evaluated using the Visual Analog Scale. Outcome measures were collected before and after the colonoscopy procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients receiving routine care without additional counseling |
| Intervention | Experimental | Other: Online Nursing CounselingPatients receiving nurse-delivered online counseling before colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years
- Literate
- No communication or hearing impairment
- Conscious and able to respond to questions
- Scheduled for colonoscopy
Key exclusion criteria (13 listed)
- Age <18 years
- Illiterate
- Presence of communication or hearing impairment
- Cognitive impairment or inability to provide informed consent
- Not scheduled for colonoscopy
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 |
|---|---|---|
| Online Nursing CounselingParticipants received nurse-delivered online counseling based on standard colonoscopy preparation materials. The intervention started approximately 24 hours before the procedure and included an initial face-to-face education session, followed by 24-hour telephone support and reminder messages. Participants were also able to contact the nurse for questions during this period. | Other | Intervention |
Primary outcome
State Anxiety Level
Time frame: Before and after colonoscopy procedure (same day)
Measured using the State-Trait Anxiety Inventory (State Anxiety Scale; score range 20-80, higher scores indicate higher anxiety).
2 secondary outcomes
Pain Level
Time frame: Before and after colonoscopy procedure (same day)
Comfort Level
Time frame: Before and after colonoscopy procedure (same day)
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 24 Jun 2026.
- Background: PubMed 25223578Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Richard Boland C, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2014 Oct;109(10):1528-45. doi: 10.1038/ajg.2014.272. Epub 2014 Sep 16. No abstract available.
- Background: PubMed 32377915Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep. 2020 May 6;22(6):28. doi: 10.1007/s11894-020-00764-4.
- Background: PubMed 24454341Shieh TY, Chen MJ, Chang CW, Hung CY, Hu KC, Kuo YC, Shih SC, Wang HY. Effect of physician-delivered patient education on the quality of bowel preparation for screening colonoscopy. Gastroenterol Res Pract. 2013;2013:570180. doi: 10.1155/2013/570180. Epub 2013 Dec 17.
- Background: PubMed 32557475Alvarez-Gonzalez MA, Pantaleon Sanchez MA, Bernad Cabredo B, Garcia-Rodriguez A, Frago Larramona S, Nogales O, Diez Redondo P, Puig Del Castillo I, Romero Mascarell C, Caballero N, Romero Sanchez-Miguel I, Perez Berbegal R, Hernandez Negrin D, Bujedo Sadornill G, Perez Oltra A, Casals Urquiza G, Amoros Martinez J, Seoane Urgorri A, Ibanez Zafon IA, Gimeno-Garcia AZ. Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial. Endoscopy. 2020 Nov;52(11):1026-1035. doi: 10.1055/a-1178-9844. Epub 2020 Jun 17.
- Background: PubMed 28848777Elvas L, Brito D, Areia M, Carvalho R, Alves S, Saraiva S, Cadime AT. Impact of Personalised Patient Education on Bowel Preparation for Colonoscopy: Prospective Randomised Controlled Trial. GE Port J Gastroenterol. 2017 Jan;24(1):22-30. doi: 10.1159/000450594. Epub 2016 Nov 1.
- Background: PubMed 27741260Kurlander JE, Sondhi AR, Waljee AK, Menees SB, Connell CM, Schoenfeld PS, Saini SD. How Efficacious Are Patient Education Interventions to Improve Bowel Preparation for Colonoscopy? A Systematic Review. PLoS One. 2016 Oct 14;11(10):e0164442. doi: 10.1371/journal.pone.0164442. eCollection 2016.
- Background: PubMed 30385831Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
- BackgroundYılmaz E, Aslan A, Ergın E. Kolonoskopi Yapılacak Hastalarda Bağırsak Temizliğine Öz Etkililik Düzeylerinin Etkisi. CBU-SBED. 2018;5(4):192-198.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to ethical and confidentiality considerations.
Related trials for Colonoscopy (Procedure)
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Not yet recruiting
Effects of Low-Dose Ketamine Added to Propofol Sedation During Colonoscopy
Colonoscopy Procedures, Sedation
Not yet recruiting
Optical Diagnosis of Neoplasia Using Artificial Intelligence
Polyps Colorectal, Colonoscopy
Recruiting
A Clinic-wide Intervention (Primary Care-GI Connect) for Improving Rates of Colonoscopy After Abnormal Fecal Immunochemical Test Result in Patients at Federally Qualified Health Centers
Colorectal Carcinoma
Recruiting
Therapeutic Effects of Music on Procedural Outcomes
Procedural Sedation, Gastrointestinal Endoscopy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Nursing Counseling in people with Colonoscopy (Procedure) and 18 Years and Over, run by Sanko 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 13 inclusion and 13 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 24 Jun 2026. 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?
State Anxiety Level (time frame: Before and after colonoscopy procedure (same day)). 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 NCT07664800, which also lists 8 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 24 Jun 2026.