- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07664800
Online Nursing Counseling and Colonoscopy Outcomes
23. juni 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Tyrkiet (Türkiye), 27090
- Sanko University Faculty of Health Sciences, Nursing Department
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control Group
Patients receiving routine care without additional counseling
|
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2023
Primær færdiggørelse (Faktiske)
1. april 2023
Studieafslutning (Faktiske)
30. juni 2023
Datoer for studieregistrering
Først indsendt
7. maj 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SANKOU-HEMS-SBS-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be publicly available due to ethical and confidentiality considerations.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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