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Clinical Trials/NCT06699173
NCT06699173
Completed
Not Applicable

Effect of Heat Aplication to Patients During Cystoscopy Procedure on Pain, Anxiety and Comfort Level A: Randomized Controlled Trial

Emine Karakaya1 site in 1 country62 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urological Nursing
Sponsor
Emine Karakaya
Enrollment
62
Locations
1
Primary Endpoint
Pain due to rigid cystoscopy
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
November 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Emine Karakaya
Responsible Party
Sponsor Investigator
Principal Investigator

Emine Karakaya

Nurse

Celal Bayar University

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.

Outcomes

Primary Outcomes

Pain due to rigid cystoscopy

Time Frame: 20 minutes

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

Anxiety due to rigid cystoscopy

Time Frame: 5 minutes

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

Confort levels due to rigid cystoscopy

Time Frame: 5 minutes

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

Study Sites (1)

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