AnxietyNCT07228884
Verbal Suggestion to Reduce Pain and Anxiety During Unsedated Colonoscopy
A study testing Verbal Suggestion in people with Anxiety and Pain, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy is an important diagnostic and screening procedure for colorectal diseases, but it can cause pain and anxiety, especially when performed without sedation. Verbal suggestion techniques - in which the physician provides calm, positive, and encouraging communication during the procedure - may help reduce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Pain, Colonoscopy
- What is being tested?
- Verbal Suggestion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 30 Dec 2025
- Phase
- Interventional
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
- Adults aged 18 to 70 years.
- Patients scheduled for elective, diagnostic, or screening colonoscopy without sedation.
- Ability to understand and provide written informed consent.
- Ability to communicate verbally with the endoscopist during the procedure.
- ASA (American Society of Anesthesiologists) physical status classification I-II.
Who cannot join
- Refusal or inability to provide informed consent.
- Known psychiatric or neurological disorders that could affect anxiety or pain perception.
- Use of anxiolytic, sedative, or analgesic drugs within 24 hours before the procedure.
- Colonoscopy performed under sedation or anesthesia.
- Severe cardiopulmonary comorbidities (ASA class ≥ III).
- Incomplete colonoscopy due to technical or anatomical reasons.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Yenimahalle, 06500
About this study
Official title: Improving Patient Comfort Without Sedation: The Impact of Verbal Suggestion on Anxiety and Pain During Colonoscopy
Colonoscopy is an important diagnostic and screening procedure for colorectal diseases, but it can cause pain and anxiety, especially when performed without sedation. Verbal suggestion techniques - in which the physician provides calm, positive, and encouraging communication during the procedure - may help reduce these unpleasant experiences.
This randomized controlled study aims to evaluate the effect of verbal suggestion on pain and anxiety levels of patients undergoing unsedated colonoscopy. Sixty adult patients will be randomly assigned to either a verbal suggestion group or a control group. In the verbal suggestion group, the endoscopist will use positive and supportive phrases during the procedure (for example: "You are doing great," "Take a deep breath, we'll get through this easily"). The control group will undergo colonoscopy without any verbal intervention.
Read more
Pain will be assessed using a Visual Analog Scale (VAS) and anxiety will be measured with the Beck Anxiety Inventory (BAI) before and after the procedure. Heart rate will also be monitored as an objective indicator of anxiety.
The goal of this study is to determine whether verbal suggestion can improve patient comfort and tolerance during colonoscopy without sedation, potentially providing a low-cost and practical method to enhance patient experience.
- Conditions
- Anxiety, Pain, Colonoscopy, Patient Comfort, Sedation-Free Procedure
- Being tested
- Verbal Suggestion
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal SuggestionBehavioural
During unsedated colonoscopy, the endoscopist will use positive verbal suggestions aimed at reducing patients' anxiety and perceived pain. The phrases include encouraging and calming statements such as "You are doing well," "Take a deep breath," and "We're almost done." The communication is supportive, consistent, and non-directive throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Verbal Suggestion Group | Experimental | Patients undergoing unsedated colonoscopy will receive positive verbal suggestion from the endoscopist throughout the procedure (e.g., "You are doing great," "Take a deep breath," "It will be over soon.") Receives: Behavioral: Verbal Suggestion |
| Control Group | No intervention | Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety level before and after colonoscopy
Anxiety will be assessed using the Beck Anxiety Inventory (BAI). BAI scores will be obtained immediately before the procedure and within 10 minutes after completion of the colonoscopy. Higher scores indicate greater anxiety.
Measured: Immediately before and within 10 minutes after the procedure
Pain intensity during colonoscopy
Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Pain scores will be recorded at 5 minutes after the start of the procedure and at 10-minute intervals thereafter during colonoscopy.
Measured: During colonoscopy
Secondary outcomes (2)
Heart rate during colonoscopy
Heart rate was recorded immediately before the procedure, at 5 minutes after the start of colonoscopy, and at 10-minute intervals thereafter during the procedure.
Measured: Before and during colonoscopy
Oxygen saturation (SpO₂) during colonoscopy
Peripheral oxygen saturation (SpO₂) was recorded immediately before the procedure, at 5 minutes after the start of colonoscopy, and at 10-minute intervals thereafter during the procedure.
Measured: Before and during colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start30 Apr 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Keskin, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228884
- Sponsor's protocol ID
- 2025-03/54
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No