Effect of Heat Aplication to Patients During Cystoscopy Procedure

NCT06699173 | Completed DMC

• 1 other identifier: 221346001,CelalBayarU
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study was planned to determine the effect of hot application, which is one of the non-pharmacological methods that can be applied to reduce pain during the Rigid Cystoscopy procedure, on pain, anxiety and comfort levels on 62 persons.As a result, it was found that there was a statistically significant difference between the visual comparison scale scores during and after the procedure according to the participants' groups.

Conditions

Urological Nursing

Keywords

Anxiety; Confort; Cystoscopy; Heat Application; Pain; Bladder Tumor

Outcome Measures

Primary Outcomes (3)

• Pain due to rigid cystoscopy

  Vusiel analog scale was used(VAS, 0(good) - 10cm (worse)

  20 minutes

• Anxiety due to rigid cystoscopy

  The state anxiety scale scores .The highest score is 80 (worse) and the lowest score is 20(good).

  5 minutes

• Confort levels due to rigid cystoscopy

  General Comfort Scale Short Form (28(worse) -168(good)

  5 minutes

Study Arms (2)

İntervention Group

EXPERIMENTAL

Experimental : Heat application was not applied routinely to the intervention group, and unlike the intervention group, heat application was not applied only with thermophor to the control group. However, the scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used. Thermophor Prosedure Before the cystoscopy procedure, the temperature of the water was measured as 40-45°C. Approximately two-thirds of the bag was filled with hot water and the air in the bag was removed. The bag was dried and checked for leakage, then wrapped with the bag's cover and placed on the patient's lower abdomen body area 5 minutes before the cystoscopy procedure.

Other: Heat ped

Control Group

NO INTERVENTION

The scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used.

Interventions

Heat ped OTHER

The hot ped was used during ricig cystoscopy

İntervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rigid (rigid) cystoscopy was performed for diagnosis and / or treatment purposes (bladder tumor).

You may not qualify if:

• Urinary hematuria. Urinary tract infection Overactive bladder Pelvic pain etc. A mental health disease, who had communication problems. Under 18 years of age. Anesthesia, Not agree to participate in the research were excluded from the study.

Sponsors & Collaborators

• Emine Karakaya: lead

Study Sites (1)

Celal Bayar Üniversity

Manisa, Turkey (Türkiye)

Location

Related Publications (4)

• Seklehner S, Engelhardt PF, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Wehrberger C, Librenjak D, Hubner W, Breinl E, Riedl C. Anxiety and depression analyses of patients undergoing diagnostic cystoscopy. Qual Life Res. 2016 Sep;25(9):2307-14. doi: 10.1007/s11136-016-1264-z. Epub 2016 Mar 17.

  PMID: 26984467 BACKGROUND

• Kim SB, Yoon SG, Tae J, Kim JY, Shim JS, Kang SG, Cheon J, Lee JG, Kim JJ, Kang SH. Detection and recurrence rate of transurethral resection of bladder tumors by narrow-band imaging: Prospective, randomized comparison with white light cystoscopy. Investig Clin Urol. 2018 Mar;59(2):98-105. doi: 10.4111/icu.2018.59.2.98. Epub 2018 Feb 8.

  PMID: 29520385 BACKGROUND

• Kwon OS, Kwon B, Kim J, Kim BH. Effects of Heating Therapy on Pain, Anxiety, Physiologic Measures, and Satisfaction in Patients Undergoing Cystoscopy. Asian Nurs Res (Korean Soc Nurs Sci). 2022 May;16(2):73-79. doi: 10.1016/j.anr.2022.02.002. Epub 2022 Feb 20.

  PMID: 35196580 BACKGROUND

• Casteleijn NF, Vriesema JL, Stomps SP, van Balen OL, Cornel EB. The effect of office based flexible and rigid cystoscopy on pain experience in female patients. Investig Clin Urol. 2017 Jan;58(1):48-53. doi: 10.4111/icu.2017.58.1.48. Epub 2017 Jan 4.

  PMID: 28097268 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Kıvan Çevik Kaya

  Manisa Celal Bayar Üniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Model Details: randomize two grup intervention and control grup

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: November 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: November 1, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)