- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07664800
Online Nursing Counseling and Colonoscopy Outcomes
23. juni 2026 oppdatert av: Sinem Bebek, Sanko University
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Tyrkia (Türkiye), 27090
- Sanko University Faculty of Health Sciences, Nursing Department
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Group
Patients receiving routine care without additional counseling
|
|
|
Eksperimentell: Intervention
Patients receiving nurse-delivered online counseling before colonoscopy
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
State Anxiety Level
Tidsramme: 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).
|
Before and after colonoscopy procedure (same day)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Level
Tidsramme: Before and after colonoscopy procedure (same day)
|
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.
|
Before and after colonoscopy procedure (same day)
|
|
Comfort Level
Tidsramme: Before and after colonoscopy procedure (same day)
|
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.
|
Before and after colonoscopy procedure (same day)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Yang 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.
- Millien 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.
- Shieh 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.
- 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.
- Alvarez-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.
- Elvas 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.
- Kurlander 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.
- Yılmaz E, Aslan A, Ergın E. Kolonoskopi Yapılacak Hastalarda Bağırsak Temizliğine Öz Etkililik Düzeylerinin Etkisi. CBU-SBED. 2018;5(4):192-198.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2023
Primær fullføring (Faktiske)
1. april 2023
Studiet fullført (Faktiske)
30. juni 2023
Datoer for studieregistrering
Først innsendt
7. mai 2026
Først innsendt som oppfylte QC-kriteriene
23. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SANKOU-HEMS-SBS-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be publicly available due to ethical and confidentiality considerations.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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