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Completed

NCT Number: NCT06699173

Effect of Heat Aplication to Patients During Cystoscopy Procedure

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heat ped

Other

The hot ped was used during ricig cystoscopy

Primary outcomes

  1. Pain due to rigid cystoscopy

    Time frame: 20 minutes

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

  2. 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).

  3. Confort levels due to rigid cystoscopy

    Time frame: 5 minutes

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

Sponsors and collaborators

Lead sponsor

Emine Karakaya

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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