Verbale forslag for å redusere smerte og angst under ubedøvet koloskopi
Forbedre pasientkomfort uten sedasjon: Effekten av verbal suggestjon på angst og smerte under koloskopi
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.
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Yenimahalle
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Ankara, Yenimahalle, Tyrkia (Türkiye), 06500
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Verbal Suggestion Group
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.") |
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. |
|
Ingen inngripen: Control Group
Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in anxiety level before and after colonoscopy
Tidsramme: Immediately before and within 10 minutes after the procedure
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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. |
Immediately before and within 10 minutes after the procedure
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|
Pain intensity during colonoscopy
Tidsramme: 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. |
During colonoscopy
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart rate during colonoscopy
Tidsramme: Before and 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. |
Before and during colonoscopy
|
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Oxygen saturation (SpO₂) during colonoscopy
Tidsramme: Before and during colonoscopy
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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. |
Before and during colonoscopy
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-03/54
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