Clinical trial NCT06699173: Effect of Heat Aplication to Patients During Cystoscopy Procedure
Official title: Effect of Heat Aplication to Patients During Cystoscopy Procedure on Pain, Anxiety and Comfort Level A: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urological Nursing
Keywords: Anxiety
Confort
Cystoscopy
Heat Application
Pain
Bladder Tumor
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: randomize two grup intervention and control grup
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This 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.

This study is a randomized controlled experimental study to determine the effect of heat application on patients' pain, anxiety and comfort levels during the cystoscopy procedure. The population of the research consisted of individuals who were hospitalized in the Cystoscopy unit of Manisa Provincial Health Directorate Merkez Efendi State Hospital between November 2023 - June 2024, and the sample consisted of individuals who met the inclusion criteriaan dagreed to participate in the research. Participants (n=62) were randomized into two groups: intervention (n=31) and control group (n=31) in a 1:1 ratio, using random numbers generated by the simple randomization method on the computer. The intervention group consisted of 5 women and 26 men, the control group consisted of 8 women and 23 men, a total of 13 women and 49 men who is over over 18 years The sample group was presented according to the CONSORT diagram. 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.

Eligibility criteria: Inclusion Criteria:

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

Does not require anesthesia. Over 18 years old No communication barrier without severe disease Cystoscopy for the first time or for control purposes İndividuals who participated in this research for the first time and agreed to participate in the research constituted the inclusion criteria.

Exclusion Criteria:

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.

Primary outcomes:
measure: Pain due to rigid cystoscopy
timeFrame: 20 minutes
measure: Anxiety due to rigid cystoscopy
timeFrame: 5 minutes
measure: Confort levels due to rigid cystoscopy
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mani̇sa
country: Turkey
facility: Celal Bayar Üniversity
Study officials:
affiliation: Manisa Celal Bayar Üniversity
name: Kıvan Çevik Kaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.